Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
54
Countries
4
Sites
12
Hospital-Acquired Pneumonia
Evaluate the PK of ATM-AVI for the treatment of serious gram-negative bacterial infections in participants 9 months to <18 years of age. Evaluate the safety, and tolerability of ATM-AVI and BAT for the treatment of serious gram-negative bacterial infections in participants 9 months to <18 years of age.
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 24 Apr 2023 → ongoing
- Decision date (initial)
- 2023-01-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Pfizer Inc.
External identifiers
- EU CT number
- 2022-501575-12-00
- ClinicalTrials.gov
- NCT05639647
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Pharmacokinetic
Evaluate the PK of ATM-AVI for the treatment of serious gram-negative bacterial infections in participants 9 months to <18 years of age.
Evaluate the safety, and tolerability of ATM-AVI and BAT for the treatment of serious gram-negative bacterial infections in participants 9 months to <18 years of age.
Secondary objectives 1
- Describe the efficacy of ATM-AVI and BAT for the treatment of serious gram-negative bacterial infections in participants 9 months to <18 years of age.
Conditions and MedDRA coding
Hospital-Acquired Pneumonia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10046571 | Urinary tract infection | 100000004862 |
| 20.0 | LLT | 10076918 | Hospital acquired pneumonia | 10021881 |
| 20.0 | PT | 10040047 | Sepsis | 100000004862 |
| 20.0 | PT | 10021789 | Infection | 100000004862 |
| 20.1 | LLT | 10065153 | Ventilator associated pneumonia | 10021881 |
| 20.1 | PT | 10056519 | Abdominal infection | 100000004862 |
| 20.1 | PT | 10060945 | Bacterial infection | 100000004862 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Overall design This is an interventional, randomized, multiple dose, open-label, active control, observer blinded, treatment study in participants 9 months to <18 years of age who are hospitalized with cIAI, cUTI, HAP/VAP, or BSI.
Test Product – Aztreonam-Avibactam ATM-AVI
Co-medication – Metronidazole MTZ
Comparators – Best Available Therapy (BAT). BAT will be based upon site practice and local epidemiology, administered at a dose and formulation per standard of care. The choice of BAT for each participant must be recorded prior to randomization.
|
Randomised Controlled | None | ATM-AVI: Experimental. Participants will receive an IV ATM-AVI loading dose and maintenance doses q6h or q8h according to renal function for: - Minimum of 3 days - Maximum of 14 days BAT: Active comparator. BAT dose as specified in local package insert and SoC including other medications as appropriate for anaerobic coverage for a maximum of 14 days |
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-002283-PIP01-17
- Plan to share IPD
- Yes
- IPD plan description
- Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participants ≥9 months to <18 years of age at Screening; Female (post-menarchal) participants must have a negative serum/urine pregnancy test (βhCG sensitivity ≥25 mIU/mL).
- Suspected/confirmed cIAI, cUTI, HAP/VAP, or BSI with gram-negative pathogens.
- Require hospitalization and IV antibiotic treatment.
Exclusion criteria 10
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- Gram-negative species not expected to respond to ATM-AVI ≤14 days.
- Pregnant or breastfeeding; fertile male/female unwilling/unable to use effective contraception for at ≥7 days (males) or ≥28 days (females) after last ATM-AVI infusion.
- (HAP/VAP only): Microbiologically known or high likelihood of monomicrobial infection with a gram-positive organism, lung abscess, pleural empyema, or postobstructive pneumonia, lung or heart transplant.
- Received >24 hours of systemic antibiotics during the 48 hours before randomization unless participant has documented treatment failure after at least 48 hours of antibiotic therapy.
- Current use of any prohibited concomitant medication(s) or unwilling/unable (Cockayne Syndrome patients with cIAI are excluded) to use MTZ or having received previous investigational drug(s) or vaccine ≤30 days or 5 half-lives before randomization (whichever is longer).
- CrCL ≤15 mL/min/1.73 m2 (eCrCl or eGFR calculation based on age).
- Non-infectious related screening ALT or AST >3 x ULN, ALP >3 x ULN and/or TBili >2 x ULN (> 3 x ULN for Gilbert’s syndrome).
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
- Previous enrollment in the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 5
- PK parameters including CL, Cmax, Cmin, AUC and t1/2
- Plasma concentrations of ATM and AVI on Day 1 and at steady state (Day 2 or later)
- AEs and SAEs
- Adverse events leading to discontinuation and adverse events resulting in death
- Assessments of liver and renal functions tests at baseline, while on treatment and after end of treatment
Secondary endpoints 2
- Clinical outcomes at EOIV, EOT, and TOC.
- Microbiological response at EOIV, EOT, and TOC.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
PRD9691867 · Product
- Active substance
- Metronidazole
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 21000 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- INFORLIFE S.A.
- Paediatric formulation
- No
- Orphan designation
- No
Metronidazole 500mg/100ml Solution for Infusion
PRD568112 · Product
- Active substance
- Metronidazole
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 21000 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XD01 — METRONIDAZOLE
- Marketing authorisation
- PL 03551/0033
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Metronidazole 500 mg / 100 ml Intravenous Infusion
PRD314054 · Product
- Active substance
- Metronidazole
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 21000 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- P01AB01, J01XD01 — METRONIDAZOLE, METRONIDAZOLE
- Marketing authorisation
- PL 00116/0353
- MA holder
- BAXTER HEALTHCARE LTD.
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Avibactam 600 mg Powder for Concentrate for Solution for Infusion
PRD9761603 · Product
- Active substance
- Avibactam Sodium
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2167 mg milligram(s)
- Max total dose
- 28167 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- PFIZER INC.
- Paediatric formulation
- No
- Orphan designation
- No
Aztreonam and Avibactam (1.5g/0.5g) Powder for Concentrate for Solution for Infusion
PRD10484084 · Product
- Active substance
- Aztreonam
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 6500 mg milligram(s)
- Max total dose
- 84500 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- PFIZER INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9854304 · Product
- Active substance
- Aztreonam
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 6500 g gram(s)
- Max total dose
- 84500 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
PRD9753160 · Product
- Active substance
- Aztreonam
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 6500 mg milligram(s)
- Max total dose
- 84500 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- HOSPIRA INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9753144 · Product
- Active substance
- Aztreonam
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 6500 mg milligram(s)
- Max total dose
- 84500 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- HOSPIRA INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 15
-
J01D · Product
- Pharmaceutical form
- -
- Route of administration
- IV INJECTION, IV INFUSION
- Max daily dose
- 1 g gram(s)
- Max total dose
- 1 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01D — OTHER BETA-LACTAM ANTIBACTERIALS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP25200128 · ATC
- Active substance
- Colistimethate Sodium
- Substance synonyms
- COLISTIMETHATE SODIUM (A COMPONENT), COLISTIN SODIUM METHANESULFONATE, COLISTIN SULPHOMETHATE SODIUM, SODIUM COLISTINEMETHANESULFONATE, SODIUM COLISTINMETHANESULPHONATE, SODIUM COLISTIN METHANESULFONATE
- Route of administration
- INJECTION
- Max daily dose
- 9000000 IU international unit(s)
- Max total dose
- 9000000 IU international unit(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XB01 — COLISTIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1150651 · ATC
- Active substance
- Moxifloxacin
- Route of administration
- INFUSION
- Max daily dose
- 400 mg/Kg milligram(s)/kilogram
- Max total dose
- 400 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01MA14 — MOXIFLOXACIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP2135408 · ATC
- Active substance
- Amoxicillin
- Substance synonyms
- AMOXICILLINE, AMOXICILLINUM
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CA01 — AMPICILLIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP3763802 · ATC
- Active substance
- Linezolid
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 1200 mg/Kg milligram(s)/kilogram
- Max total dose
- 1200 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XX08 — LINEZOLID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP2656997 · ATC
- Active substance
- Clindamycin
- Substance synonyms
- CLINDAMYCINUM
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01FF01 — CLINDAMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP28152028 · ATC
- Active substance
- Cilastatin
- Substance synonyms
- LSALT peptide
- Route of administration
- INFUSION
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DH51 — IMIPENEM AND ENZYME INHIBITOR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
J01XX · Product
- Pharmaceutical form
- PHF00230MIG
- Route of administration
- INFUSION
- Max daily dose
- 600 mg/Kg milligram(s)/kilogram
- Max total dose
- 600 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XX — OTHER ANTIBACTERIALS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP4996412 · ATC
- Active substance
- Amikacin
- Route of administration
- INTRAVENOUS
- Max daily dose
- 20 mg/Kg milligram(s)/kilogram
- Max total dose
- 20 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01GB06 — AMIKACIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP2149338 · ATC
- Active substance
- Amoxicillin
- Substance synonyms
- AMOXICILLINE, AMOXICILLINUM
- Route of administration
- SOLUTION FOR INJECTION OR INFUSION
- Max daily dose
- 5 mg/Kg milligram(s)/kilogram
- Max total dose
- 5 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP165584 · ATC
- Active substance
- Linezolid
- Route of administration
- INTRAVENOUS
- Max daily dose
- 6 g gram(s)
- Max total dose
- 6 g gram(s)
- Max treatment duration
- 10 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01DH02 — MEROPENEM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP6155006 · ATC
- Active substance
- Betamethasone Valerate
- Substance synonyms
- BETAMETHASONE 17-VALERATE
- Route of administration
- INJECTION
- Max daily dose
- 5 mg/Kg milligram(s)/kilogram
- Max total dose
- 5 pg picogram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01GB03 — GENTAMICIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP6198093 · ATC
- Active substance
- Teicoplanin
- Substance synonyms
- Teichomycin A2
- Route of administration
- INTRAVENOUS
- Max daily dose
- 12 mg/Kg milligram(s)/kilogram
- Max total dose
- 12 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA02 — TEICOPLANIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP2094796 · ATC
- Active substance
- Piperacillin
- Route of administration
- INTRAVENOUS
- Max daily dose
- 12 g gram(s)
- Max total dose
- 12 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP17545011 · ATC
- Active substance
- Vancomycin
- Substance synonyms
- VANCOMYCINUM
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 40 mg/Kg milligram(s)/kilogram
- Max total dose
- 40 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 235 East 42nd Street
- City
- New York
- Postcode
- 10017-5703
- Country
- United States
Scientific contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| PAREXEL INTERNATIONAL (IRL) Limited ORG-100022780
|
Dublin, Ireland | Other |
| Innovative Trials Limited ORG-100044081
|
Letchworth Garden City, United Kingdom | Other |
| Excelya Greece CRO Single Member S.A. ORG-100009224
|
Vrilissia, Greece | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100012849
|
Meyrin, Switzerland | Laboratory analysis |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Fisher Clinical Services UK Limited ORG-100012049
|
Horsham, United Kingdom | Other |
Locations
4 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 7 | 2 |
| Greece | Ongoing, recruiting | 5 | 2 |
| Hungary | Ongoing, recruiting | 4 | 2 |
| Spain | Ongoing, recruiting | 4 | 6 |
| Rest of world
India, China, United States, Taiwan, Turkey
|
— | 34 | — |
Investigational sites
Krajska zdravotni a.s.
Detske a dorostove oddeleni, J. E. Purkyne 270, 434 01, Most
Oblastni nemocnice Kolin a.s. nemocnice Stredoceskeho kraje
Detske oddeleni, Zizkova 146, 280 02, Kolin III
University General Hospital Of Heraklion
Pediatric Intensive Care, Stavrakia And Voutes, 715 00, Heraklion
Ippokratio General Hospital Of Thessaloniki
3rd Pediatric Department, Konstadinoupoleos 49, 546 42, Thessaloniki
Semmelweis University
Gyermekgyogyaszati Klinika Bokay utcai reszleg, Bokay Janos Utca 53, 1083, Budapest VIII
Semmelweis University
Gyermekgyogyaszati Klinika Tuzolto utcai reszleg, Tuzolto Utca 7-9, 1094, Budapest
Hospital Sant Joan De Deu Barcelona
Infectology Unit, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Hospital Universitario La Paz
Pediatria y Enfermedades Infecciosas, Paseo Castellana 261, 28046, Madrid
Hospital Universitario 12 De Octubre
Unidad Pediátrica de Investigación y Ensayos Clín, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitari Vall D Hebron
Pediatric infectious disease and Immunodeficient Unit, Passeig De La Vall D Hebron 119-129, 08035, Barcelona
Hospital Universitario HM Monteprincipe
Pediatrics, Avenida de Monteprincipe, 25, Madrid
Hospital Universitari Germans Trias I Pujol
Infectious disease Unit, Ctra. Canyet S/n, Edificio General 1a Planta, Badalona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2023-04-28 | 2025-11-24 | |||
| Greece | 2023-05-04 | 2025-01-15 | |||
| Hungary | 2023-04-24 | 2025-02-22 | |||
| Spain | 2023-04-17 | 2023-06-13 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-2646
- Halt date
- 2023-06-16
- Planned restart
- 2023-07-14
- Member states concerned
- Spain
- Publication date
- 2023-06-27
- Reason
- Medicinal Product related
- Explanation
- This is a temporary hold resolving soon not related to safety. Expiring IP for which replacement inventory is pending. Study has no patient enrolled in Spain.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 120 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | ATM-AVI_PACL for C3601008 New EU CT Number Original 2_Public | 1 |
| Protocol (for publication) | ATM-AVI_Protocol Final_C3601008_PF-06947387_Greek_Public | Am4 |
| Protocol (for publication) | ATM-AVI_Protocol Final_C3601008_PF-06947387_Public | Am4 |
| Protocol (for publication) | C3601008 Protocol_tracked changes_Public | NA |
| Protocol (for publication) | C3601008_Protocol Final Approval Clinical and Stats ePhotocopy_Public | Am1 |
| Recruitment arrangements (for publication) | C3601008_HCP referral letter__EL_Public | 1 |
| Recruitment arrangements (for publication) | C3601008_Informed consent flipbook_CZ CS_Public | 1 |
| Recruitment arrangements (for publication) | C3601008_Informed consent flipbook_EL__Public | 1 |
| Recruitment arrangements (for publication) | C3601008_Informed consent flipbook_Spain_Public | 1 |
| Recruitment arrangements (for publication) | C3601008_Physician poster_EL_Public | 1 |
| Recruitment arrangements (for publication) | C3601008_Physician poster_Spain_Public | 1 |
| Recruitment arrangements (for publication) | C3601008_Recruitment and Informed consent procedure_Public | 1.0 |
| Recruitment arrangements (for publication) | C3601008_Recruitment-Consent procedure_Greece_Public | 2 |
| Recruitment arrangements (for publication) | C3601008_Recruitment-Consent procedure_Public | V2 |
| Recruitment arrangements (for publication) | C3601008_Study brochure_CZ CS_Public | 1 |
| Recruitment arrangements (for publication) | C3601008_Study brochure_EL_Public | 1 |
| Recruitment arrangements (for publication) | C3601008_Study brochure_Spain_Public | 1 |
| Recruitment arrangements (for publication) | C3601008_Study intro presentation_EL_Public | 1 |
| Recruitment arrangements (for publication) | C3601008_Study visit guide_CZ_CS_Public | 2 |
| Recruitment arrangements (for publication) | C3601008_Study visit guide_Spain_Public | 2 |
| Recruitment arrangements (for publication) | C3601008_Thoughtful Closure_Caregiver Thank You Card_CZ CS_Public | 1 |
| Recruitment arrangements (for publication) | C3601008_Thoughtful Closure_Participant Thank You Card_CZ CS_Public | 1 |
| Recruitment arrangements (for publication) | K1_C3601008_K Recruitment arrangements_Statement_HU_Public | 1 |
| Recruitment arrangements (for publication) | K1a C3601008_Study visit guide_EL_Public | 2 |
| Recruitment arrangements (for publication) | K7_C3601008_Physician poster_CZ CS_Public | 1 |
| Subject information and informed consent form (for publication) | C3601008 Assent 10 to 12 GR GRE TC_Public | N/A |
| Subject information and informed consent form (for publication) | C3601008 Assent 10 up to 12yo_GR_Public | 3.1 |
| Subject information and informed consent form (for publication) | C3601008 Assent 13 to 15 GR GRE TC_Public | N/A |
| Subject information and informed consent form (for publication) | C3601008 Assent 16 to 18 GR GRE TC_Public | N/A |
| Subject information and informed consent form (for publication) | C3601008 Assent 16 up to 18yo_GR_Public | 3.1 |
| Subject information and informed consent form (for publication) | C3601008 Assent Older 13 to 15_GR_Public | 3.1 |
| Subject information and informed consent form (for publication) | C3601008 Assent Older Country Level Greece_el-GR_Public | 1 |
| Subject information and informed consent form (for publication) | C3601008 Assent Younger Country Level Greece_el-GR_Public | 1 |
| Subject information and informed consent form (for publication) | C3601008 ICD Majority age GR GRE_TC_Public | N/A |
| Subject information and informed consent form (for publication) | C3601008 ICD Parents_GR _GRE_TC_Public | N/A |
| Subject information and informed consent form (for publication) | C3601008 PPRIF_Czech Republic_GDPR_final_CZ_Public | 1.0 |
| Subject information and informed consent form (for publication) | C3601008_Assent Older_Spain_ES_Public | N/A |
| Subject information and informed consent form (for publication) | C3601008_Assent younger COUNTRY level_Spain_ES_public | N/A |
| Subject information and informed consent form (for publication) | C3601008_ECC_Greece-English_Public | 1 |
| Subject information and informed consent form (for publication) | C3601008_EU PRIVACY SUPPLEMENT_NOTICE Czechia Adult_CZ_Public | 1.0 |
| Subject information and informed consent form (for publication) | C3601008_EU PRIVACY SUPPLEMENT_NOTICE Czechia Parent_CZ_Public | 1.0 |
| Subject information and informed consent form (for publication) | C3601008_ICD update due to Scout_EL_Public | 2.0 |
| Subject information and informed consent form (for publication) | C3601008_Pfizer_Study Information_Card_GR_Public | V1.0 |
| Subject information and informed consent form (for publication) | C3601008_S621_SC_PFD_Email Comm_ERR-TR_Spain_ES_public | 2.0 |
| Subject information and informed consent form (for publication) | C3601008_S621_SC_PFD_ScoutPass Reloadable_spain_public | V1_0 |
| Subject information and informed consent form (for publication) | C3601008_S621_SC_PFD_Study Brochure_spain_public | V1_0 |
| Subject information and informed consent form (for publication) | C3601008_SC_PFD_ScoutPass_EUR_Reloadable_CHAInformation_Spain_ES_Public | 3.0 |
| Subject information and informed consent form (for publication) | C3601008_Scout Email communication_EL_Public | 1.0 |
| Subject information and informed consent form (for publication) | C3601008_Scout Study Brochure_EL_Public | 1.0 |
| Subject information and informed consent form (for publication) | C3601008_Spain_Assent Older_TC_Public | N/A |
| Subject information and informed consent form (for publication) | C3601008_Spain_Assent younger_TC_Public | N/A |
| Subject information and informed consent form (for publication) | C3601008_Spain_ICD for Majority of Age_TC_Public | N/A |
| Subject information and informed consent form (for publication) | C3601008_Spain_ICD Majority of Age_Public | N/A |
| Subject information and informed consent form (for publication) | C3601008_Spain_ICD Parents_Public | N/A |
| Subject information and informed consent form (for publication) | C3601008_Spain_ICD Parents_TC_Public | N/A |
| Subject information and informed consent form (for publication) | C3601008_Spain_PPRIF_Public | Ver1_1 |
| Subject information and informed consent form (for publication) | C3601008_Spain_PPRIF_TC_Public | N/A |
| Subject information and informed consent form (for publication) | C3601008_Study Information Card_ES_ES_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_1a C3601008 ICD Assent 12-14_CZ_CS_Public | 03/03/00 |
| Subject information and informed consent form (for publication) | L1_2a_C3601008 ICD Assent 15-17_CZ_CS_Public | 03/03/00 |
| Subject information and informed consent form (for publication) | L1_3a C3601008 ICD Majority Age_CZ_CS_Public | 07/06/00 |
| Subject information and informed consent form (for publication) | L1_4a C3601008 ICD Parents_CZ_CS_Public | 07/06/00 |
| Subject information and informed consent form (for publication) | L1_5a_C3601008_Study Information Card_CZ_CS_Public | 1.0 |
| Subject information and informed consent form (for publication) | L10a_C3601008_ScoutPass_Reloadable_EUR_CHAInformation_HU-HU_Public | 3.0 |
| Subject information and informed consent form (for publication) | L11a_C3601008_S621_SC_PFD_ScoutPass Reloadable_EUR_HU-HU_Public | 1.0 |
| Subject information and informed consent form (for publication) | L12a_C3601008_S621_SC_PFD_Email Comm_ERR-TR_HU-HU_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1a_C3601008_Hungary_Assent_Older Age_13-17y_Hun_Public | na |
| Subject information and informed consent form (for publication) | L2a_C3601008_Hungary_Assent_Younger Age_7-12y_Hun_Public | na |
| Subject information and informed consent form (for publication) | L3a_C3601008_Hungary_Parent ICD_Hun_Public | na |
| Subject information and informed consent form (for publication) | L3c_C3601008_Hungary_Parent ICD_Hun_TC_Public Placeholder | na |
| Subject information and informed consent form (for publication) | L4a_C3601008_Hungary_Majority age ICD_Hun_Public | na |
| Subject information and informed consent form (for publication) | L4c_C3601008_Hungary_Majority age ICD_Hun_TC_Publicplaceholder | na |
| Subject information and informed consent form (for publication) | L5a_C3601008_Hungary_PPRIF_Hun_Public | 1_1 |
| Subject information and informed consent form (for publication) | L6_C3601008_Hungary_List of submitted ICDs_Public | 2 |
| Subject information and informed consent form (for publication) | L7 C3601008 Informed Consent for Majority Age_GR_Public | 6.0 |
| Subject information and informed consent form (for publication) | L7_C3601008_Hungary_Short description of submitted ICDs_Hun_Public | 1 |
| Subject information and informed consent form (for publication) | L8a_C3601008_SIC_HU-HU_Public | 1.0 |
| Subject information and informed consent form (for publication) | L9 C3601008 Informed Consent for Parents_GR_Public | 6.0 |
| Subject information and informed consent form (for publication) | L9_C3601008_S621_SC_PFD_Study Brochure_HU-HU_Public | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | Amikacin 250 mg_ml Injection UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Ampicillin 500 mg powder for solution for injection UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Avelox 400 mg_250 ml solution for infusion UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | AZACTAM_US PI | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | AZACTAM_US PI | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | AZACTAM_US PI | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Aztreonam for Injection US PI_Hospira | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Aztreonam for Injection US PI_Hospira | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Aztreonam for Injection US PI_Hospira | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Ceftazidime 1g Powder for solution for injection or infusion UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Ceftriaxone 1g Powder for solution for injection or infusion UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Clindamycin 150mg_ml Solution for Injection or Infusion UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Co-amoxiclav 1000 mg_200 mg Powder for Solution for Injection_Infusion UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Colistimethate Sodium 1 Million I_U_Powder for Solution for Injection UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Daptomycin 350 mg powder for solution for injection_infusion UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | ERTAPENEM 1 g powder for concentrate for solution for infusion UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Gentamicin 10mg_ml Solution for Injection or Infusion UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Meronem IV 500mg UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Metronidazole 500mg_100ml Solution for Infusion UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Piperacillin_Tazobactam 4 g_0_5 g Powder for Solution for Infusion UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | PRIMAXIN IV 500 mg_500 mg powder for solution for infusion UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Recarbrio 500 mg_500 mg_250 mg powder for solution for infusion UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Renapime 2 g powder for solution for injection_infusion UK SmPC_08Dec2017 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC - Metronidazole 500 mg _ 100 ml Intravenous Infusion - Baxter UK | NA |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC - Metronidazole 500 mg _ 100 ml Intravenous Infusion - Baxter UK | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC - Metronidazole 500 mg _ 100 ml Intravenous Infusion - Baxter UK | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Targocid 400mg powder for solution for injection_infusion or oral solution UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Vancomycin 1g Powder for Solution for Infusion UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Zavicefta 2 g_0_5 g powder for concentrate for solution for infusion EU SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Zinforo 600 mg powder for concentrate for solution for infusion UK SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Zyvox 2 mg_ml solution for infusion UK SmPC | 1 |
| Synopsis of the protocol (for publication) | ATM-AVI_Protocol Synopsis C3601008_Protocol-Synopsis_EN_Public | Am4 |
| Synopsis of the protocol (for publication) | C3601008 Protocol Synopsis tracked changes CZ_Public | NA |
| Synopsis of the protocol (for publication) | C3601008 Protocol Synopsis tracked changes EN_Public | NA |
| Synopsis of the protocol (for publication) | C3601008 Protocol Synopsis tracked changes ES_Public | NA |
| Synopsis of the protocol (for publication) | C3601008 Protocol Synopsis tracked changes GR_Public | NA |
| Synopsis of the protocol (for publication) | C3601008 Protocol Synopsis tracked changes HU_Public | NA |
| Synopsis of the protocol (for publication) | C3601008_Protocol-Synopsis_EN-cze_Public | Am4 |
| Synopsis of the protocol (for publication) | C3601008_Protocol-Synopsis_Greece_Public | Am4 |
| Synopsis of the protocol (for publication) | C3601008_Protocol-Synopsis_Hungary_Public | Am4 |
| Synopsis of the protocol (for publication) | C3601008_Protocol-Synopsis_Spain_Public | Am4 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-08-31 | Spain | Acceptable with conditions 2022-12-19
|
2022-12-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-03-17 | Spain | Acceptable 2023-06-09
|
2023-06-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-26 | Spain | Acceptable with conditions 2024-02-15
|
2024-02-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-03-05 | Acceptable with conditions | 2024-04-30 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-03-27 | Acceptable with conditions | 2024-05-02 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-04-17 | Spain | Acceptable with conditions | 2024-04-29 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-04-19 | Acceptable with conditions | 2024-07-08 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-07-23 | Spain | Acceptable 2024-09-10
|
2024-09-23 |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-10-29 | Acceptable | 2024-12-11 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-10-29 | Acceptable | 2025-01-30 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-10-29 | Acceptable | 2024-12-11 | |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-03 | Spain | 2025-02-03 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-02-07 | Spain | Acceptable 2025-04-11
|
2025-04-11 |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-15 | Spain | Acceptable 2025-04-11
|
2025-10-15 |