C3601008 - A PHASE 2A MULTICENTER, OBSERVER-BLINDED, RANDOMIZED 2 ARM STUDY TO INVESTIGATE PHARMACOKINETICS, SAFETY, TOLERABILITY AND EFFICACY OF INTRAVENOUS AZTREONAM-AVIBACTAM ± METRONIDAZOLE COMPARED TO BEST AVAILABLE THERAPY (BAT) IN PEDIATRIC PARTICIPANTS 9 MONTHS TO LESS THAN 18 YEARS OF AGE WITH SERIOUS GRAM-NEGATIVE BACTERIAL INFECTIONS INCLUDING COMPLICATED INTRA-ABDOMINAL INFECTION

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501575-12-00

Acronym

C3601008

Enrollment

Registered

2022-12-20

Start date

2023-04-24

Completion date

Unknown

Last updated

2025-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospital-Acquired Pneumonia, Ventilator-Associated Pneumonia, complicated gram-negative bacterial infections, Sepsis, Blood Stream Infection, Intra-abdominal Infection, Urinary Tract Infection

Brief summary

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

Detailed description

Clinical outcomes at EOIV, EOT, and TOC., Microbiological response at EOIV, EOT, and TOC.

Interventions

DRUGAztreonam and Avibactam (1.5g/0.5g) Powder for Concentrate for Solution for Infusion

DRUGAMIKACIN

DRUGGENTAMICIN

DRUGAztreonam

DRUGAMOXICILLIN AND ENZYME INHIBITOR

DRUGMetronidazole

DRUGMetronidazole 500mg/100ml Solution for Infusion

DRUGTEICOPLANIN

DRUGCOLISTIN

DRUG-

DRUGMetronidazole 500 mg / 100 ml Intravenous Infusion

DRUGMEROPENEM

DRUGAMPICILLIN

DRUGIMIPENEM AND ENZYME INHIBITOR

DRUGLINEZOLID

DRUGAvibactam 600 mg Powder for Concentrate for Solution for Infusion

DRUGMOXIFLOXACIN

DRUGPIPERACILLIN AND ENZYME INHIBITOR

DRUGCLINDAMYCIN

DRUGVANCOMYCIN

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Secondary

Measure	Time frame
Clinical outcomes at EOIV, EOT, and TOC., Microbiological response at EOIV, EOT, and TOC.	—

Primary

Measure	Time frame
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	—

Countries

Czechia, Greece, Hungary, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026