Efficacy and safety of 7 versus 14 days of antibiotic treatment for bacteremia produced by Pseudomonas aeruginosa: a multicenter, randomized (SHORTEN-2) clinical trial with a DOOR/RADAR analysis.

2023-508441-41-00 Protocol SHORTEN-II Therapeutic use (Phase IV) Authorised, recruiting

Start 8 Jul 2024 · Status Authorised, recruiting · 1 EU/EEA countries · 37 sites · Protocol SHORTEN-II

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruiting
Participants planned 306
Countries 1
Sites 37

Bacteriemia producida por P. aeruginosa.

Determine if a 7-day antibiotic treatment regimen is superior to a 14-day regimen in the treatment of P. aeruginosa bacteremia, evaluating in an integrated manner both the effectiveness of the short regime and its potential to reduce serious adverse events and antibiotic exposure.

Key facts

Sponsor
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Bacterial Infections and Mycoses [C01]
Trial duration
8 Jul 2024 → ongoing
Decision date (initial)
2024-07-08
Transition trial
Yes
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No
Funding sources
ICI21/00075 (ISCIII)

External identifiers

EU CT number
2023-508441-41-00
EudraCT number
2021-003847-10
ClinicalTrials.gov
NCT05210439

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Prophylaxis, Safety, Therapy

Determine if a 7-day antibiotic treatment regimen is superior to a 14-day regimen in the treatment of P. aeruginosa bacteremia, evaluating in an integrated manner both the effectiveness of the short regime and its potential to reduce serious adverse events and antibiotic exposure.

Secondary objectives 6

  1. Determine whether the short regime is non-inferior to the long regime in terms of recurrence of infection and mortality, and whether the interruption of antibiotic treatment is can safely apply at the individual level using a simple clinic decision.
  2. Describe the adverse effects and superinfections, and specifically the produced by multidrug-resistant bacteria and C. difficile in both treatment regimens.
  3. To analyze the efficiency of short regimens in terms of number of treatment days and days of hospital stay avoided at the end of the follow-up period.
  4. Determine risk factors related to treatment failure and risk of recurrence.
  5. Confirm recurrence of infections by sequencing P. aeruginosa isolates that occur during follow-up.
  6. Compare the effect of short and long treatment regimens on preservation of the diversity of the intestinal microbiota.

Conditions and MedDRA coding

Bacteriemia producida por P. aeruginosa.

VersionLevelCodeTermSystem organ class
20.0 LLT 10021860 Infection Pseudomonas aeruginosa 10021881

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Adult patients (18 years or older).
  2. Present bacteremia due to P. aeruginosa.
  3. Having received 6 days (+/-1) of active antibiotic treatment against bacteremia counted from the date of extraction of the first positive blood culture and until the moment of randomization.
  4. Have signed the informed consent for the trial.

Exclusion criteria 13

  1. Minors under 18 years of age.
  2. Pregnant or breastfeeding women. Potentially fertile patients must have a negative pregnancy test.
  3. Focus of bacteremia not adequately controlled at least 72 hours before randomization.
  4. Bacteremia secondary to an infection that necessarily requires prolonged antibiotic treatment, greater than 7 days, including: -Post-obstructive or necrotizing pneumonia. -Lung abscesses. -Acute prostatitis. -Bone and joint infections. -Central nervous system infections. -Endovascular infections related to vascular prostheses. -Any other at the discretion of the doctor responsible for the patient.
  5. Coexistence of a different infection at the time of diagnosis of bacteremia that also requires antibiotic treatment if their treatment will be extended beyond 7 days from the diagnosis of bacteremia by P. aeruginosa. On the contrary, in the event that an infection coexists whose treatment ends before randomization, the patient may be included. Also in case there are isolates other than P. aeruginosa in samples corresponding to colonizations that do not require antibiotic treatment (asymptomatic bacteriuria, contamination of blood cultures by colonizers usual, bronchoaspirates without symptoms or signs suggestive of infection respiratory), the patient may be included in the trial..
  6. Bacteremic pneumonia in severely immunocompromised patients, defined as: -Patients with severe neutropenia (<500 cells/mm3). -Recipients of allogeneic hematopoietic stem cell or solid organ transplant, during the first year after the transplant. -Active graft-versus-host disease requiring immunosuppressive treatment. -Patients with solid tumors who are receiving chemotherapy. -Untreated HIV infection with CD4 < 200 cells/mm3. -Patients with primary combined immunodeficiency. -Steroid treatment with prednisone > 20 mg/day (or equivalent) for 14 days prior to randomization.
  7. Bacteremia of any origin in patients with severe neutropenia (<500 cells/mm3) at the time of randomization.
  8. Bacteremia of any origin in large burns.
  9. Bacteremia produced by strains resistant to all beta-lactams and quinolones.
  10. Polymicrobial bacteremia including microorganisms other than P. aeruginosa. Polymicrobial bacteremia is considered the isolation in blood of more than one bacteria other than P.aeruginosa with clinical significance. P.aeruginosa bacteremias that are accompanied by isolates considered as contaminations (coagulase-negative staphylococci or viridans group streptococci, etc.) without clinical significance can be recruited for the trial, since these will not require specific treatment, and should not be considered polymicrobial bacteremia for the purposes of the assay.
  11. Patients in palliative care or with an expected survival of less than 48 hours at the time of randomization.
  12. Bacteremia due to P. aeruginosa in the previous 30 days as long as the previous infection has not been resolved.
  13. The doctor responsible for the patient does not want to include the patient in the clinical trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Days of antibiotic treatment and DOOR scale category (Desirability of Outcome Ranking) at the end of follow-up: Day +30 after the end of aproppriate antibiotic treatment.

Secondary endpoints 2

  1. All-cause mortality, clinical cure and treatment failure: Days +30 and +90 after the end of aproppriate antibiotic treatment.
  2. Superinfections, serious adverse events, days of hospital stay, and recurrences (proven, probable or possible): Day +90 after the end of aproppriate antibiotic treatment.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 19

Fetcroja 1 g powder for concentrate for solution for infusion

PRD8030186 · Product

Active substance
Cefiderocol
Substance synonyms
S-649266
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
3 g gram(s)
Max total dose
21 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01DI04 — -
Marketing authorisation
EU/1/20/1434/001
MA holder
SHIONOGI B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Levofloxacino Kabi 5 mg/ml solución para perfusión.

PRD2054373 · Product

Active substance
Levofloxacin Hemihydrate
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1 g gram(s)
Max total dose
7 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01MA12 — LEVOFLOXACIN
Marketing authorisation
72160
MA holder
FRESENIUS KABI ESPAÑA S.A.U.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Quofenix 450 mg tablets

PRD7784298 · Product

Active substance
Delafloxacin
Substance synonyms
RX-3341-83
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
0.9 g gram(s)
Max total dose
6.3 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01MA23 — -
Marketing authorisation
EU/1/19/1393/004
MA holder
A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Colistimetato de sodio Altan Pharma 2 millones de UI polvo para solución inyectable y para perfusión

PRD990683 · Product

Active substance
Colistimethate Sodium
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS
Max daily dose
9 million IU million international units
Max total dose
63 million IU million international units
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01XB01 — COLISTIN
Marketing authorisation
78300
MA holder
ALTAN PHARMACEUTICALS S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cefepima Accord 1 g polvo para solución inyectable y para perfusión EFG

PRD2910717 · Product

Active substance
Cefepime
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS
Max daily dose
6 g gram(s)
Max total dose
42 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01DE01 — -
Marketing authorisation
75148
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

CIPROFLOXACINO KABI 2 mg/ml solución para perfusion

PRD409000 · Product

Active substance
Ciprofloxacin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1.2 g gram(s)
Max total dose
8.4 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01MA02 — CIPROFLOXACIN
Marketing authorisation
68.095
MA holder
FRESENIUS KABI ESPAÑA S.A.U.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Azactam 1g polvo para solución inyectable

PRD390109 · Product

Active substance
Aztreonam
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
8 g gram(s)
Max total dose
56 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01DF01 — AZTREONAM
Marketing authorisation
57.781
MA holder
BRISTOL-MYERS SQUIBB SA
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Zerbaxa 1 g/0.5 g powder for concentrate for solution for infusion

PRD6367587 · Product

Active substance
Tazobactam
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
9 g gram(s)
Max total dose
63 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01DI54 — -
Marketing authorisation
EU/1/15/1032/001
MA holder
MERCK SHARP & DOHME B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Zavicefta 2 g/0.5 g powder for concentrate for solution for infusion

PRD5220052 · Product

Active substance
Ceftazidime
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
7.5 g gram(s)
Max total dose
52.5 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01DD52 — -
Marketing authorisation
EU/1/16/1109/001
MA holder
PFIZER IRELAND PHARMACEUTICALS
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Quofenix 300 mg powder for concentrate for solution for infusion

PRD7784322 · Product

Active substance
Delafloxacin
Substance synonyms
RX-3341-83
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
0.6 g gram(s)
Max total dose
4.2 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01MA23 — -
Marketing authorisation
EU/1/19/1393/001
MA holder
A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vaborem 1 g/1 g powder for concentrate for solution for infusion

PRD7110245 · Product

Active substance
Meropenem
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
12 g gram(s)
Max total dose
84 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01DH52 — -
Marketing authorisation
EU/1/18/1334/001
MA holder
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tobramicina NORMON 50 mg/2 ml solución inyectable EFG

PRD408294 · Product

Active substance
Tobramycin
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
0.84 g gram(s)
Max total dose
5.88 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01GB01 — TOBRAMYCIN
Marketing authorisation
65.262
MA holder
LABORATORIOS NORMON, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

MONOFLOX 500 mg comprimidos recubiertos con película EFG

PRD10177465 · Product

Active substance
Levofloxacin Hemihydrate
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1 g gram(s)
Max total dose
7 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01MA12 — LEVOFLOXACIN
Marketing authorisation
84399
MA holder
ARAFARMA GROUP, S.A
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Amicacina Braun 500 mg Solución inyectable

PRD6253384 · Product

Active substance
Amikacin
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
3.6 g gram(s)
Max total dose
25.2 g gram(s)
Max treatment duration
7 Week(s)
Authorisation status
Authorised
ATC code
J01GB — OTHER AMINOGLYCOSIDES
Marketing authorisation
58.048
MA holder
B.BRAUN MEDICAL, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Qilu 1 g polvo para solución inyectable y para perfusión EFG

PRD10354376 · Product

Active substance
Meropenem
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS
Max daily dose
6 g gram(s)
Max total dose
42 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
88778
MA holder
QILU PHARMA SPAIN S.L.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

ciprofloxacino cinfa 750 mg comprimidos recubiertos EFG

PRD542764 · Product

Active substance
Ciprofloxacin
Pharmaceutical form
COATED TABLET
Route of administration
ORAL
Max daily dose
1.5 g gram(s)
Max total dose
10.5 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01MA02 — CIPROFLOXACIN
Marketing authorisation
62.766
MA holder
LABORATORIOS CINFA, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piperacilina/Tazobactam Sala 4 g/0,5 g polvo para solución para perfusión EFG

PRD325456 · Product

Active substance
Piperacillin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
13.5 g gram(s)
Max total dose
94.5 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
Marketing authorisation
68.080
MA holder
LABORATORIO REIG JOFRE, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftazidima SALA 1.000 mg polvo para solución para perfusión EFG

PRD353937 · Product

Active substance
Ceftazidime
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
6 g gram(s)
Max total dose
42 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01DD02 — -
Marketing authorisation
67.871
MA holder
LABORATORIO REIG JOFRE, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Imipenem/Cilastatina Kabi 500/500 mg, polvo para solución para perfusión

PRD1164091 · Product

Active substance
Cilastatin Sodium
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
4 g gram(s)
Max total dose
28 g gram(s)
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
J01DH51 — IMIPENEM AND ENZYME INHIBITOR
Marketing authorisation
71.285
MA holder
FRESENIUS KABI ESPAÑA S.A.U.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 19

LEVOFLOXACINO NORMON 500 mg Comprimidos recubiertos con película EFG.

PRD407790 · Product

Active substance
Levofloxacin Hemihydrate
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1 g gram(s)
Max total dose
14 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01MA12 — LEVOFLOXACIN
Marketing authorisation
69697
MA holder
LABORATORIOS NORMON, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Levofloxacino Netpharmalab 5mg/ml solución para perfusión EFG

PRD10243972 · Product

Active substance
Levofloxacin
Substance synonyms
HR355
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1 g gram(s)
Max total dose
14 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01MA12 — LEVOFLOXACIN
Marketing authorisation
88679
MA holder
NETPHARMALAB CONSULTING SERVICES S.L.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fetcroja 1 g powder for concentrate for solution for infusion

PRD8031117 · Product

Active substance
Cefiderocol
Substance synonyms
S-649266
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
3 g gram(s)
Max total dose
42 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01DI04 — -
Marketing authorisation
EU/1/20/1434/001
MA holder
SHIONOGI B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

CEFEPIME ACCORD 1 g, poudre pour solution injectable/pour perfusion (IM/IV)

PRD8039359 · Product

Active substance
Cefepime
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS
Max daily dose
6 g gram(s)
Max total dose
84 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01DE01 — -
Marketing authorisation
34009 302 054 3 3
MA holder
ACCORD HEALTHCARE FRANCE SAS
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Quofenix 300 mg powder for concentrate for solution for infusion

PRD7784465 · Product

Active substance
Delafloxacin
Substance synonyms
RX-3341-83
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
0.6 g gram(s)
Max total dose
8.4 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01MA23 — -
Marketing authorisation
EU/1/19/1393/001
MA holder
A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L.
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piperacilina/Tazobactam Accord 4 g/0,5 g polvo para solución para perfusión EFG

PRD366120 · Product

Active substance
Piperacillin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
13.5 g gram(s)
Max total dose
189 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
Marketing authorisation
67.903
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Zavicefta 2 g/0.5 g powder for concentrate for solution for infusion

PRD5220187 · Product

Active substance
Ceftazidime
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
7.5 g gram(s)
Max total dose
105 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01DD52 — -
Marketing authorisation
EU/1/16/1109/001
MA holder
PFIZER IRELAND PHARMACEUTICALS
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftazidima Sala 1.000 mg polvo para solución inyectable EFG

PRD353939 · Product

Active substance
Ceftazidime
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
6 g gram(s)
Max total dose
84 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01DD02 — -
Marketing authorisation
67.873
MA holder
LABORATORIO REIG JOFRE, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Zerbaxa 1 g/0.5 g powder for concentrate for solution for infusion

PRD6367589 · Product

Active substance
Tazobactam
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
9 g gram(s)
Max total dose
126 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01DI54 — -
Marketing authorisation
EU/1/15/1032/001
MA holder
MERCK SHARP & DOHME B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tobramicina NORMON 100 mg/2 ml solución inyectable EFG

PRD408298 · Product

Active substance
Tobramycin
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
0.84 g gram(s)
Max total dose
11.76 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01GB01 — TOBRAMYCIN
Marketing authorisation
65.261
MA holder
LABORATORIOS NORMON, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Quofenix 450 mg tablets

PRD7784299 · Product

Active substance
Delafloxacin
Substance synonyms
RX-3341-83
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
0.9 g gram(s)
Max total dose
12.6 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01MA23 — -
Marketing authorisation
EU/1/19/1393/003
MA holder
A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

AMIKACINE B. BRAUN 2,5 mg/ml, solution pour perfusion

PRD2767396 · Product

Active substance
Amikacin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
3.6 g gram(s)
Max total dose
50.4 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01GB06 — AMIKACIN
Marketing authorisation
34009 579 231 3 6
MA holder
B.BRAUN MELSUNGEN AG
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vaborem 1 g/1 g powder for concentrate for solution for infusion

PRD7110343 · Product

Active substance
Meropenem
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
12 g gram(s)
Max total dose
168 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01DH52 — -
Marketing authorisation
EU/1/18/1334/001
MA holder
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

CIPROFLOXACINO KABI 2 mg/ml solución para perfusión

PRD409001 · Product

Active substance
Ciprofloxacin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1.2 g gram(s)
Max total dose
16.8 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01MA02 — CIPROFLOXACIN
Marketing authorisation
68.095
MA holder
FRESENIUS KABI ESPAÑA S.A.U.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Imipenem/Cilastatina Aurovitas 500 mg/500 mg polvo para solución para perfusión EFG

PRD10293737 · Product

Active substance
Cilastatin Sodium
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
4 g gram(s)
Max total dose
56 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01DH51 — IMIPENEM AND ENZYME INHIBITOR
Marketing authorisation
72.637
MA holder
EUGIA PHARMA (MALTA) LTD
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Colistimetato de sodio Accord 2 millones de UI polvo para solución inyectable y para perfusión EFG

PRD4089815 · Product

Active substance
Colistimethate Sodium
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS
Max daily dose
9 million IU million international units
Max total dose
126 million IU million international units
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01XB01 — COLISTIN
Marketing authorisation
80899
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

MEROPENEM QILU 1 g, poudre pour solution injectable/pour perfusion

PRD10138989 · Product

Active substance
Meropenem
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS
Max daily dose
6 g gram(s)
Max total dose
84 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
34009 302 648 2 9
MA holder
QILU PHARMA SPAIN S.L.
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Azactam 1 g Powder for Solution for Injection or Infusion

PRD6017634 · Product

Active substance
Aztreonam
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS
Max daily dose
8 g gram(s)
Max total dose
112 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01DF01 — AZTREONAM
Marketing authorisation
PL 12038/0002
MA holder
BRISTOL-MYERS SQUIBB PHARMACEUTICALS UNLIMITED COMPANY
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ciprofloxacino Aurovitas 750 mg comprimidos recubiertos con película EFG

PRD3260370 · Product

Active substance
Ciprofloxacin
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1.5 g gram(s)
Max total dose
21 g gram(s)
Max treatment duration
14 Day(s)
Authorisation status
Authorised
ATC code
J01MA02 — CIPROFLOXACIN
Marketing authorisation
80.161
MA holder
AUROVITAS SPAIN,S.A.U.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla

13 Total trials 7 Recruiting 6 Ended
Academic / Non-commercial
Sponsor organisation
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
Address
Avenida De Manuel Siurot S/n
City
Sevilla
Postcode
41013
Country
Spain

Scientific contact point

Organisation
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
Contact name
Coordinadora/monitor médico y de seguridad.

Public contact point

Organisation
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
Contact name
Coordinadora/monitor médico y de seguridad.

Locations

1 EU/EEA country · 37 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Authorised, recruiting 306 37
Rest of world — 0 —

Investigational sites

Spain

37 sites · Authorised, recruiting
Hospital Universitario De Cruces
infectious diseases, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario Clinico San Cecilio
infectious diseases, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital Universitario Y Politecnico La Fe
Medicina intensiva, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario La Paz
infectious diseases, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Lucus Augusti
infectious diseases, Rua Dr. Ulises Romero 1, 27003, Lugo
Parc Tauli Hospital Universitari
infectious diseases, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Clinica Universidad De Navarra
infectious diseases, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Fundacion Jimenez Diaz
infectious diseases, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Regional De Malaga
infectious diseases, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital San Pedro
infectious diseases, Calle Piqueras 98, 26006, Logrono
University Hospital Son Espases
infectious diseases, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario Virgen De Valme
infectious diseases, Avenida Bellavista S/n, 41014, Sevilla
Hospital General Universitario De Valencia
infectious diseases, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital De La Santa Creu I Sant Pau
infectious diseases, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario Torrecardenas
infectious diseases, Calle Paraje Torrecardenas S/n, 04009, Almeria
Hospital Universitari Vall D Hebron
infectious diseases, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Bellvitge University Hospital
infectious diseases, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat
Hospital Universitario Central De Asturias
Medicina Intensiva, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario Donostia
infectious diseases, Pasealeku Doct. Begiristain 109, 20014, Donostia
Hospital Clinico Universitario Lozano Blesa
infectious diseases, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario Marques De Valdecilla
infectious diseases, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario De Burgos
infectious diseases, Avenida De Las Islas Baleares 3, 09006, Burgos
Hospital Universitario Ramon Y Cajal
infectious diseases, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario De Puerto Real
infectious diseases, Carretera Nacional IV Km 665 S/N, 11510, Puerto Real
University Hospital Virgen Del Rocio S.L.
infectious diseases, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Virgen De La Macarena
infectious diseases, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital General Universitario Dr. Balmis
infectious diseases, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Clinico Universitario De Valladolid
Microbiología e Inmunología, Avenida Ramon Y Cajal 3, 47003, Valladolid
Hospital De Jerez De La Frontera
infectious diseases, Carretera De La Ronda Circunvalacion S/n, 11407, Jerez De La Frontera
Hospital Universitario Reina Sofia
infectious diseases, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Virgen De Las Nieves
infectious diseases, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Universitario Puerta Del Mar
Microbiología, Avenida De Ana De Viya 21, 11009, Cadiz
Complexo Hospitalario Universitario De Vigo
infectious diseases, Estrada Clara Campoamor N 341, 36312, Vigo
Complexo Hospitalario Universitario A Coruna
infectious diseases, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Costa Del Sol
infectious diseases, Terreno Autovia Mediterraneo A-7 S/n, 29603, Marbella
Hospital Universitario De Jaen
infectious diseases, Avenida Del Ejercito Espanol 10, 23007, Jaen
Hospital Universitario Juan Ramon Jimenez
infectious diseases, Ronda Exterior Norte S/n, 21005, Huelva

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Spain 2024-07-08

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 43 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2023-508441-41-00 3.1
Recruitment arrangements (for publication) K1_ Recruitment arrangements_SHORTEN II 1
Subject information and informed consent form (for publication) L1_SIS and ICF adults CRF adults_SHORTEN II V3 3
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Amikacina 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Amikacina 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Aztreonam 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Aztreonam 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Cefepima 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Cefepima 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Cefiderocol 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Cefiderocol 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ceftazidima 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ceftazidima 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ceftazidima-avibactam 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ceftazidima-avibactam 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ceftolozano-Tazobactam 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ceftolozano-Tazobactam 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ciprofloxacino IV 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ciprofloxacino IV 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ciprofloxacino oral 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ciprofloxacino oral 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Colistina 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Colistina 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Delafloxacino IV 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Delafloxacino IV 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC delafloxacino_oral 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC delafloxacino_oral 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Imipenem 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Imipenem 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC LEVOFLOXACINO IV 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC LEVOFLOXACINO IV 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Levofloxacino oral 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Levofloxacino oral 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Meropenem 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Meropenem 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Meropenem- Varboractam 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Meropenem- Varboractam 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Piperacilina-Tazobactam 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Piperacilina-Tazobactam 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Tobramicina 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Tobramicina 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_ENG 2023-508441-41-00 3.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_ES 2023-508441-41-00 3.1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-06-20 Spain Acceptable
2024-07-08
 2024-07-08
2 SUBSTANTIAL MODIFICATION SM-1 2025-07-23 Spain Acceptable 2025-07-25