Ceftazidime (±avibactam) with IV fosfomycin versus ceftazidime alone for hospitalized adults with severe suspected Gram‑negative infection
Official title: Ceftazidime Plus Fosfomycin Versus Ceftazidime Alone for Severe Gram-negative Infections: a Triple-blind, Placebo-controlled Point-of-care Randomized Clinical Trial
Run by University of Geneva, Switzerland · NCT07063095 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Geneva, Switzerland Academic / other |
| Locations | 1 site (Geneva, Canton of Geneva) |
| Status | Recruiting |
| Started | August 25, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | September 26, 2025 |
| Trial ID | NCT07063095 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
MiRNA markers in septic shock patients
This study tests whether microRNA patterns can help explain changes in immune marker HLA-DR on monocytes in adults with septic shock.
-
Dynamic SvO2 to predict fluid responsiveness in septic shock
This study tests whether dynamic central venous oxygen saturation can predict which septic shock patients will respond to fluid boluses.
-
Fast antibiotic sensitivity tests to guide treatment for bloodstream infections
This tests whether rapid antibiotic susceptibility tests can help doctors pick the right antibiotics sooner for adults with positive blood cultures and improve recovery and antibiotic use.
-
Adjunctive Fludrocortisone in Septic Shock
This study tests adding fludrocortisone to usual care for adults with septic shock to see if it helps patients survive and recover better.
-
Personalized antibiotic duration for high-risk febrile neutropenia with Gram-negative bloodstream infection
This trial tests whether stopping antibiotics after a patient with a blood cancer and febrile neutropenia has been clinically stable for 72 hours is as safe and lets them spend more days off anti–Gram-negative antibiotics than the usual at least 10-day approach.
-
Education on Immunosuppressive Therapy Reduction in Kidney Transplant Recipients in ICU with Sepsis or Respiratory Failure
In kidney transplant patients who are in the ICU for septic shock or severe respiratory failure, the study will test a targeted approach to adjust immunosuppressive therapy and provide education to support safer care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.