A Study to Learn About the Study Medicine Called Aztreonam-Avibactam in Neonates and Infants Less Than 9 Months of Age With Suspected or Confirmed Infections Due to Gram-Negative Bacteria

Overview

Sponsor-declared trial summary

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]

Decision date (initial)

2025-05-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Pfizer Inc

External identifiers

EU CT number

2023-507757-15-01

ClinicalTrials.gov

NCT06462235

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy

Evaluate the PK of ATM-AVI for the treatment of gram-negative bacterial infections including complicated urinary tract infection (cUTI), complicated intraabdominal infection (cIAI), hospital-acquired pneumonia (HAP)/ventilator-associated
pneumonia (VAP), blood stream infection (BSI), or sepsis in hospitalized neonates and infants from birth to <9 month of age.

Evaluate the safety and tolerability of ATM-AVI in hospitalized neonates and infants from birth to <9 months.

Secondary objectives 1

1. For Part B describe the efficacy of ATM-AVI for the treatment of gram-negative bacterial infections including cUTI, cIAI, HAP/VAP, BSI, or sepis in hospitalized neonates and infants from birth to <9 months.

Conditions and MedDRA coding

Sepsis

Study design 4 periods

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

1. Hospitalized with age from birth <9 months, including preterm birth
2. Part A: Receiving IV antibiotics for treatment of suspected or confirmed bacterial infection, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis.
3. Part B: Suspected or confirmed gram-negative bacterial infection requiring IV antibiotics, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis.

Exclusion criteria 4

1. Received any other investigational medicinal product within the longer of 30 days or 5 half-lives before enrollment.
2. Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
3. Severe renal impairment or known significant renal disease, as evidenced by elevated serum creatinine at screening, or urinary output <0.5 mL/kg/h for 6 consecutive hours or requirement for dialysis.
4. Part B Only: Received >24 hours of systemic antibiotic treatment for gram-negative organisms at time of enrollment, unless documented treatment failure or lack of improvement in at least one objective sign or symptom of infection after ≥48 hours of antibiotics.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. PK parameters including clearance (CL), maximum plasma concentration (Cmax), area under the plasma concentration time curve (AUC) and half-life (t1/2)
2. Plasma concentrations of ATM and AVI on Day 1 and at steady state (Day 2 or later)
3. Adverse events (AEs) and Serious Adverse Events (SAEs)
4. Adverse events leading to discontinuation and adverse events resulting in death
5. Assessments of liver and renal functions tests at baseline, while on treatment and after end of treatment

Secondary endpoints 4

1. Clinical outcomes at End of Intravenous Treatment (EOIV), End of Treatment (EOT), and Test of Cure (TOC). (Pat B only)
2. Per-pathogen microbiological response at EOIV/EOT, and TOC.
3. Per-participant microbiological response at TOC
4. Emergent infection

Investigational products

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

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

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 2

Locations

6 EU/EEA countries · 27 investigational sites

By country

Investigational sites

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

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

Documents 61 files

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

Application history

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