Ceftazidime (±avibactam) with IV fosfomycin versus ceftazidime alone for hospitalized adults with severe suspected Gram‑negative infection
Ceftazidime Plus Fosfomycin Versus Ceftazidime Alone for Severe Gram-negative Infections: a Triple-blind, Placebo-controlled Point-of-care Randomized Clinical Trial
This trial will test whether adding intravenous fosfomycin to ceftazidime (or ceftazidime‑avibactam) helps hospitalized adults with suspected severe Gram‑negative infections recover faster than ceftazidime alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Geneva, Switzerland Academic / other |
| Locations | 1 site (Geneva, Canton of Geneva) |
| Trial ID | NCT07063095 on ClinicalTrials.gov |
What this trial studies
This Phase 3, randomized, placebo‑controlled trial enrolls hospitalized adults with suspected severe Gram‑negative bacterial infection to receive either ceftazidime (with or without avibactam) plus intravenous fosfomycin or ceftazidime plus placebo. The primary clinical aims are to see if the combination shortens the time to normalization of qSOFA parameters and lowers C‑reactive protein compared with standard therapy, while further characterizing safety. Patients must be adults able to provide consent (or have a legal representative) and have not received Gram‑negative directed antibiotics for more than 24 hours prior to inclusion. The trial is conducted at Hôpitaux Universitaires de Genève with inpatient IV antibiotic administration and blinded placebo control.
Who should consider this trial
Good fit: Hospitalized adults (≥18 years) with suspected severe Gram‑negative bacterial infection who can consent (or have a legal representative) and who have received ≤24 hours of Gram‑negative directed antibiotics are ideal candidates.
Not a fit: Pregnant or breastfeeding patients, those with known contraindications to ceftazidime/avibactam or fosfomycin, or those already on targeted Gram‑negative therapy for more than 24 hours are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding fosfomycin could shorten time to clinical improvement, reduce inflammation, and potentially lower complications and length of hospital stay.
How similar studies have performed: Preclinical data and small clinical reports suggest synergy between ceftazidime (±avibactam) and fosfomycin against some resistant Gram‑negative bacteria, but large randomized Phase 3 evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult (≥18 years) 2. Hospitalized with suspected severe Gram-negative bacterial infection 3. Signed informed consent from the patient (or oral consent from a patient with capacity but with physical inability to sign, with signed witness testimony from a person independent of the study team) of from the legal representative if the patient lacks capacity to provide informed consent Exclusion Criteria: 1. Pregnancy or lactation 2. Known contra-indication to CAZ±AVI or FOS 3. Gram-negative directed antibiotic treatment begun \>24 hours before inclusion
Where this trial is running
Geneva, Canton of Geneva
- Hôpitaux Universitaires de Genève — Geneva, Canton of Geneva, Switzerland (Recruiting)
Study contacts
- Study coordinator: Laura C Lourenço, MD
- Email: laura.lourencocordes@hug.ch
- Phone: +41795538659
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.