A Combination Therapy With Ceftazidime and Fosfomycin Will be Compared to Ceftazidime Alone in Hospitalized Adult Patients With Suspected Severe Gram-negative Bacterial Infections

PHASE3RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 25, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Gram Negative InfectionsSepsis and Septic Shock
Interventions
DRUG

Ceftazidime± avibactam with fosfomycin

"The intervention will last 72h (±6h). Ceftazidime will be administered intravenously in 5% glucose serum (per hospital standard), either intermittently (divided into three doses daily) or as continuous infusion; doses will be adapted to renal function. The decision to administer CAZ by continuous infusion and to add AVI will be left to the attending physician. CAZ±AVI will be adjusted for renal insufficiency per internal guidelines of dosing and international recommendations.~The use of CAZ with its paired beta-lactamase inhibitor avibactam, i.e., the use of ceftazidime-avibactam (Zavicefta®) instead of CAZ will occur in case of suspicion of infection by either extended-spectrum-beta-lactamase-producing Enterobacterales (ESBL-E), cephalosporinase-carrying Enterobacterales (ampC-E) or carbapenem-resistant Enterobacterales (CRE), as determined by treating physician and/or the infectious diseases consultant."

DRUG

Ceftazidime± avibactam with placebo

Participants randomized to the control arm will receive placebo infusion. Placebo will be 5% glucose serum and will be administered IV with the same frequency as FOS would be for the participant's renal function.

Trial Locations (1)

1205

RECRUITING

Hôpitaux Universitaires de Genève, Geneva

All Listed Sponsors
collaborator

Joint Programming Initiative on Antimicrobial Resistance (JPIAMR)

UNKNOWN

collaborator

Swiss National Science Foundation

OTHER

lead

Angela HUTTNER

OTHER