A Randomized Prospective Clinical Trial to Assess Procalcitonin-Guidance and Molecular-Guided Diagnosis as Mainstay for Therapy of Severe Infections (The Modify Trial)

2022-502962-26-00 Protocol MODIFY Therapeutic confirmatory (Phase III) Ongoing, recruitment ended

Start 14 Sep 2023 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 15 sites · Protocol MODIFY

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruitment ended
Participants planned 190
Countries 1
Sites 15

Severe infections

The main objective of the MODIFY trial is to decrease the number of days patients are treated with empirical broad-spectrum antibiotics.

Key facts

Sponsor
Hellenic Institute For The Study Of Sepsis
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
14 Sep 2023 → ongoing
Decision date (initial)
2023-04-27
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacoeconomic, Efficacy, Therapy

The main objective of the MODIFY trial is to decrease the number of days patients are treated with empirical broad-spectrum antibiotics.

Secondary objectives 1

  1. Secondary objectives refer to the impact of the MODIFY strategy on clinical outcomes as this is expressed by time to optimal therapy, the change of the SOFA (sequential organ failure assessment) score and mortality.

Conditions and MedDRA coding

Severe infections

VersionLevelCodeTermSystem organ class
20.0 PT 10040047 Sepsis 100000004862

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

  1. Male or female
  2. For women of child-bearing potential, willingness to avoid pregnancy during the study and agreement to notify investigator if pregnancy occurs.
  3. Age more than or equal to 18 years
  4. Sepsis defined by the Sepsis-3 definition; this is defined separately for community-acquired sepsis and for hospital-acquired sepsis. Community-acquired sepsis is defined as any SOFA score 2 points or more for patients admitted in hospital emergencies with community-acquired pneumonia (CAP), community-acquired acute pyelonephritis (AP) or community-acquired primary bacteremia (BSI). CAP, AP and BSI are considered community-acquired for patients who have no history of hospitalization lasting more than 2 days the last 90 days or who are not under hemodialysis or who are not residents of long-term care facilities. Hospital-acquired sepsis is defined as any SOFA score increase by 2 points or more from the admission SOFA score for patients with onset of hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), acute pyelonephritis (AP) or primary bacteremia (BSI) at least 48 hours after hospital admission. For patients with history of hospitalization lasting more than 2 days the last 90 days or who are under hemodialysis or who are residents of long-term care facilities and are admitted to hospital with HAP, VAP, AP and BSI the definition of hospital-acquired sepsis applies. In this case, the baseline SOFA score is considered as the known SOFA score before infection onset.
  5. Presence of one of the following infections: community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), acute pyelonephritis (AP) and primary bacteremia (BSI).
  6. Positive blood culture
  7. Written informed consent provided by the patient or by their legal representative in case of patients unable to consent due to sepsis onset affecting their mental capacity.
  8. Patients who have completed their participation in another study for more than 30 days can be included in this study.

Exclusion criteria 8

  1. Failure to obtain written consent to participate
  2. Previous enrollment in this study within the past 90 days. Patients enrolled in another study will not be accepted.
  3. Patients in pregnancy or breastfeeding. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study
  4. Patients receiving prolonged antibiotic therapies (e.g. endocarditis, implantable device-associated infection, cerebral/hepatic abscess, osteomyelitis, meningitis)
  5. Patients with severe infections due to viruses or parasites (e.g. Dengue, Toxoplasma gondii, Plasmodium spp.)
  6. Patients with infection due to Mycobacterium tuberculosis
  7. Patients suffering from cystic fibrosis
  8. Severely immunocompromised patients such as a) patients with infection by the human immunodeficiency virus and with a CD4 count of less than 200 cells/mm3; b) neutropenic patients with less than 500 neutrophils/mm3; and c) patients with solid organ transplantation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The number of days under treatment with broad-spectrum antibiotics in the group receiving the MODIFY strategy compared to patients treated by standard of care.

Secondary endpoints 11

  1. Time to first change of antibiotics
  2. Time to the first sterile blood culture
  3. Maintenance of the same antimicrobial(s) in case of activity against the pathogen
  4. At least 2-point decrease of baseline SOFA score by day 7
  5. 28-day mortality
  6. 90-day mortality
  7. Incidence of laboratory documented Clostrioides difficile infection
  8. Length of hospital stay
  9. Cost of hospitalization
  10. Time to escalation of antibiotics
  11. Time to de-escalation of antibiotics

Investigational products

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

Test 17

Vaborbactam

SUB185581 · Substance

Active substance
Vaborbactam
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
6 g gram(s)
Max total dose
60 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftazidime

SUB07422MIG · Substance

Active substance
Ceftazidime
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
6 g gram(s)
Max total dose
60 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Avibactam

SUB72111 · Substance

Active substance
Avibactam
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1.5 g gram(s)
Max total dose
15 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piperacillin

SUB09867MIG · Substance

Active substance
Piperacillin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
16 g gram(s)
Max total dose
160 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cefuroxime

SUB07433MIG · Substance

Active substance
Cefuroxime
Pharmaceutical form
POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration
IV INFUSION
Max daily dose
4.5 g gram(s)
Max total dose
45 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Imipenem

SUB08151MIG · Substance

Active substance
Imipenem
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
4 g gram(s)
Max total dose
40 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Anidulafungin

SUB22240 · Substance

Active substance
Anidulafungin
Pharmaceutical form
POWDER FOR SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
200 mg milligram(s)
Max total dose
1.1 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Linezolid

SUB08520MIG · Substance

Active substance
Linezolid
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1.2 g gram(s)
Max total dose
12 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Colistimethate Sodium

SUB06801MIG · Substance

Active substance
Colistimethate Sodium
Pharmaceutical form
POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration
IV INJECTION, IV INFUSION
Max daily dose
9000000 IU international unit(s)
Max total dose
90000000 IU international unit(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Relebactam

SUB184909 · Substance

Active substance
Relebactam
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1 g gram(s)
Max total dose
10 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Teicoplanin

SUB04714MIG · Substance

Active substance
Teicoplanin
Pharmaceutical form
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION
Route of administration
IV INJECTION, IV INFUSION
Max daily dose
12 mg/kg milligram(s)/kilogram
Max total dose
66 mg/kg milligram(s)/kilogram
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftolozane

SUB167762 · Substance

Active substance
Ceftolozane
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
3 g gram(s)
Max total dose
30 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tazobactam

SUB10849MIG · Substance

Active substance
Tazobactam
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
2 g gram(s)
Max total dose
20 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Micafungin

SUB16444MIG · Substance

Active substance
Micafungin
Pharmaceutical form
POWDER FOR SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
150 mg milligram(s)
Max total dose
1.5 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxone

SUB07431MIG · Substance

Active substance
Ceftriaxone
Pharmaceutical form
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS INJECTION
Max daily dose
2 g gram(s)
Max total dose
20 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vancomycin

SUB05076MIG · Substance

Active substance
Vancomycin
Pharmaceutical form
POWDER FOR SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
2 g gram(s)
Max total dose
20 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem

SUB08778MIG · Substance

Active substance
Meropenem
Pharmaceutical form
POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration
IV INJECTION, IV INFUSION
Max daily dose
6 g gram(s)
Max total dose
60 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 17

Ceftriaxone

SUB07431MIG · Substance

Active substance
Ceftriaxone
Pharmaceutical form
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS INJECTION
Max daily dose
2 g gram(s)
Max total dose
20 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vaborbactam

SUB185581 · Substance

Active substance
Vaborbactam
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
6 g gram(s)
Max total dose
60 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftolozane

SUB167762 · Substance

Active substance
Ceftolozane
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
3 g gram(s)
Max total dose
30 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vancomycin

SUB05076MIG · Substance

Active substance
Vancomycin
Pharmaceutical form
POWDER FOR SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
2 g gram(s)
Max total dose
20 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piperacillin

SUB09867MIG · Substance

Active substance
Piperacillin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
16 g gram(s)
Max total dose
160 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Avibactam

SUB72111 · Substance

Active substance
Avibactam
Pharmaceutical form
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1.5 g gram(s)
Max total dose
15 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Linezolid

SUB08520MIG · Substance

Active substance
Linezolid
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1.2 g gram(s)
Max total dose
12 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Imipenem

SUB08151MIG · Substance

Active substance
Imipenem
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
4 g gram(s)
Max total dose
40 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Teicoplanin

SUB04714MIG · Substance

Active substance
Teicoplanin
Pharmaceutical form
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION
Route of administration
IV INFUSION
Max daily dose
12 mg/kg milligram(s)/kilogram
Max total dose
66 mg/kg milligram(s)/kilogram
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Colistimethate Sodium

SUB06801MIG · Substance

Active substance
Colistimethate Sodium
Pharmaceutical form
POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration
IV INJECTION, IV INFUSION
Max daily dose
9000000 IU international unit(s)
Max total dose
90000000 IU international unit(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem

SUB08778MIG · Substance

Active substance
Meropenem
Pharmaceutical form
POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration
IV INJECTION, IV INFUSION
Max daily dose
6 g gram(s)
Max total dose
60 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftazidime

SUB07422MIG · Substance

Active substance
Ceftazidime
Pharmaceutical form
POWDER FOR SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
6 g gram(s)
Max total dose
60 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tazobactam

SUB10849MIG · Substance

Active substance
Tazobactam
Pharmaceutical form
POWDER FOR SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
2 g gram(s)
Max total dose
20 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Micafungin

SUB16444MIG · Substance

Active substance
Micafungin
Pharmaceutical form
POWDER FOR SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
150 mg milligram(s)
Max total dose
1.5 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Relebactam

SUB184909 · Substance

Active substance
Relebactam
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1 g gram(s)
Max total dose
10 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Anidulafungin

SUB22240 · Substance

Active substance
Anidulafungin
Pharmaceutical form
POWDER FOR SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
200 mg milligram(s)
Max total dose
1.1 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cefuroxime

SUB07433MIG · Substance

Active substance
Cefuroxime
Pharmaceutical form
POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration
IV INJECTION, IV INFUSION
Max daily dose
4.5 g gram(s)
Max total dose
45 g gram(s)
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hellenic Institute For The Study Of Sepsis

4 Total trials 2 Recruiting 2 Ended
Academic / Non-commercial
Sponsor organisation
Hellenic Institute For The Study Of Sepsis
Address
Michalakopoulou 88
City
Athens
Postcode
115 28
Country
Greece

Scientific contact point

Organisation
Hellenic Institute For The Study Of Sepsis
Contact name
President of the board

Public contact point

Organisation
Hellenic Institute For The Study Of Sepsis
Contact name
President of the board

Third parties 1

OrganisationCity, countryDuties
Sustchem Techniki Symvouleftiki S.A.
ORG-100046975
 Athens, Greece Other, Code 8

Locations

1 EU/EEA country · 15 investigational sites

By country

CountryMS statusPlanned subjectsSites
Greece Ongoing, recruitment ended 190 15
Rest of world — 0 —

Investigational sites

Greece

15 sites · Ongoing, recruitment ended
Thoracic General Hospital Of Athens I Sotiria
3rd University Department of Internal Medicine, Messogion Avenue 152, 115 27, Athens
Thoracic General Hospital Of Athens I Sotiria
Intensive Care Unit of Center for Respiratory Failure, Messogion Avenue 152, 115 27, Athens
General Oncological Hospital Of Kifissia Agioi Anargyroi
Clinic of Intensive Care and Pulmonary Diseases Department of Nursing, University of Athens, Timio Stavrou And 14 Noufaron, 145 64, Kifissia
General Hospital Of Athens G Gennimatas
1st Department of Internal Medicine, Messogion Avenue 154, 115 27, Athens
University General Hospital Attikon
2nd Propaedeutic Department of Internal Medicine, Rimini Street 1, 124 62, Athens
Ippokratio General Hospital Of Thessaloniki
Intensive Care Unit, Konstadinoupoleos 49, 546 42, Thessaloniki
Sismanogleio General Hospital
1st Department of Internal Medicine, Sismanogliou 37, 151 26, Marousi
University General Hospital Of Alexandroupoli
2nd Department of Internal Medicine, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
Geniko Nosokomeio Peiraia Tzaneio
2nd Department of Internal Medicine, Zanni And Afentouli Street, 185 36, Piraeus
University General Hospital Attikon
4th Department of Internal Medicine, Rimini Street 1, 124 62, Athens
General Hospital Of Athens Korgialenio Benakio H.R.C.
1st Department of Internal Medicine, Athanasaki 2 Str, 115 26, Athens
General Hospital Of Eleusina Thriasio
1st Department of Internal Medicine, G Gennimata Avenue, 190 18, Eleusina
University General Hospital Of Thessaloniki Ahepa
1st Department of Internal Medicine, 1st St Kiriakidis Str, 546 36, Thessaloniki
Thoracic General Hospital Of Athens I Sotiria
New Intensive Care Unit, Messogion Avenue 152, 115 27, Athens
General Hospital of Nikaia-Piraeus “Agios Panteleimon”
3rd Department of Internal Medicine, Andrea Mantouvalou 3, 18454, PIREAUS

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Greece 2023-09-14 2023-09-15 2026-01-15

Results and documents

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

Documents 35 files

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

TypeTitleVersion
Protocol (for publication) D1 Protocol 2022-502962-26-00 CLEAN EL 7
Protocol (for publication) D1 Protocol 2022-502962-26-00 CLEAN EN 7
Protocol (for publication) D1_Protocol 2022-502962-26-00 CLEAN EL V 7 7
Protocol (for publication) D1_Protocol 2022-502962-26-00 CLEAN EN V 7 7
Protocol (for publication) D1_Protocol 2022-502962-26-00 TRACK CHANGES EL V 7 7
Protocol (for publication) D1_Protocol 2022-502962-26-00 TRACK CHANGES EN V 7 7
Recruitment arrangements (for publication) RECRUITMENT AND INFORMED CONSENT PROCEDURE REDACTED 1
Subject information and informed consent form (for publication) MODIFY_ICF REDACTED 2
Summary of Product Characteristics (SmPC) (for publication) Ecalta 1
Summary of Product Characteristics (SmPC) (for publication) Ecalta 1
Summary of Product Characteristics (SmPC) (for publication) Primaxin 1
Summary of Product Characteristics (SmPC) (for publication) Primaxin 1
Summary of Product Characteristics (SmPC) (for publication) Recarbrio 1
Summary of Product Characteristics (SmPC) (for publication) Recarbrio 1
Summary of Product Characteristics (SmPC) (for publication) Rocephin 1
Summary of Product Characteristics (SmPC) (for publication) Rocephin 1
Summary of Product Characteristics (SmPC) (for publication) Tazocin 1
Summary of Product Characteristics (SmPC) (for publication) Tazocin 1
Summary of Product Characteristics (SmPC) (for publication) Vaborem 1
Summary of Product Characteristics (SmPC) (for publication) Vaborem 1
Summary of Product Characteristics (SmPC) (for publication) Vondem 1
Summary of Product Characteristics (SmPC) (for publication) Vondem 1
Summary of Product Characteristics (SmPC) (for publication) Zavicefta 1
Summary of Product Characteristics (SmPC) (for publication) Zavicefta 1
Summary of Product Characteristics (SmPC) (for publication) Zavicefta SmPC 1
Summary of Product Characteristics (SmPC) (for publication) Zerbaxa 1
Summary of Product Characteristics (SmPC) (for publication) Zerbaxa 1
Summary of Product Characteristics (SmPC) (for publication) Zyvoxid 1
Summary of Product Characteristics (SmPC) (for publication) Zyvoxid 1
Synopsis of the protocol (for publication) D1 Protocol Synopsis 2022-502962-26-00 CLEAN EL 7
Synopsis of the protocol (for publication) D1 Protocol Synopsis 2022-502962-26-00 CLEAN EN 7
Synopsis of the protocol (for publication) D1_Protocol Synopsis 2022-502962-26-00 CLEAN EL V 7 7
Synopsis of the protocol (for publication) D1_Protocol Synopsis 2022-502962-26-00 CLEAN EN V 7 7
Synopsis of the protocol (for publication) D1_Protocol Synopsis 2022-502962-26-00 TRACK CHANGES EL V 7 7
Synopsis of the protocol (for publication) D1_Protocol Synopsis 2022-502962-26-00 TRACK CHANGES EN V 7 7

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-02-10 Greece Acceptable
2023-04-27
 2023-04-27
2 SUBSTANTIAL MODIFICATION SM-1 2023-09-12 Greece Acceptable 2023-12-04
3 SUBSTANTIAL MODIFICATION SM-3 2024-03-29 Greece Acceptable
2024-06-04
 2024-06-21
4 SUBSTANTIAL MODIFICATION SM-5 2025-02-26 Greece Acceptable
2025-05-05
 2025-05-05
5 NON SUBSTANTIAL MODIFICATION NSM-1 2025-11-03 Greece Acceptable
2025-05-05
 2025-11-03

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