Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07063095

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

Led by Angela HUTTNER · Updated on 2025-09-26

100

Participants Needed

1

Research Sites

66 weeks

Total Duration

On this page

Sponsors

A

Angela HUTTNER

Lead Sponsor

J

Joint Programming Initiative on Antimicrobial Resistance (JPIAMR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to : 1. Test whether the combination of CAZ±AVI and FOS leads to superior clinical outcomes in patients with severe suspected Gram-negative bacterial infection, as demonstrated by a shorter time to normalization of quick Sequential Organ Failure Assessment (qSOFA) parameters and reduction in C-reactive protein (CRP) compared to standard of care (CAZ±AVI alone) 2. to further characterize the safety profile of this combination therapy In the presence of such an infection, standard treatment is to start intravenous antibiotic therapy. Ceftazidime (Fortam®), or ceftazidime-avibactam (Zavicefta®), is a standard antibiotic commonly used for this purpose (for very resistant bacteria, the compound avibactam is included to protect ceftazidime from being broken down by bacteria). Researchers will compare ceftazidime (or ceftazdime-avibactam) plus fosfomycin versus ceftazidime alone with placebo (i.e. a look-alike substance given with no drug) to examine whether the addition of another intravenous antibiotic, fosfomycin, would lead to faster recovery from severe infection and evaluate the tolerability of this combination. Participants will: * Be randomly assigned to either the intervention group or the control group. * The intervention group will receive ceftazidime (with avibactam if multidrug resistant bacteria are suspected, per routine practice) and intravenous fosfomycin, and the control group will receive ceftazidime (with avibactam if multidrug resistant bacteria are suspected) and placebo. * Either treatment will be given for 3 days, three times daily (or less frequently, depending on renal function). * Provide a few extra blood samples (for CRP measurement, a protein marker of inflammation) during the first few days of the study. * Be contacted in the hospital or by phone if discharged on day 28 to be asked a few questions.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (≥18 years)
  • Hospitalized with suspected severe Gram-negative bacterial infection
  • Signed informed consent from the patient or legal representative if the patient lacks capacity
Not Eligible

You will not qualify if you...

  • Pregnancy or lactation
  • Known contra-indication to ceftazidime±avibactam or fosfomycin
  • Gram-negative directed antibiotic treatment begun more than 24 hours before inclusion

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, Switzerland, 1205

Actively Recruiting

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Research Team

L

Laura C Lourenço, MD

CONTACT

A

Angela Huttner, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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