Trial · 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
NCT07063095, Phase 3, Recruiting, Angela HUTTNER
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Combination Therapy With Ceftazidime and Fosfomycin Will be Compared to Ceftazidime Alone in Hospitalized Adult Patients With Suspected Severe Gram-negative Bacterial Infections. Trials, record NCT07063095. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07063095
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT07063095
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Angela HUTTNER
- Conditions
- Gram Negative Infections, Sepsis and Septic Shock
- Interventions
- Ceftazidime± avibactam with fosfomycin, Ceftazidime± avibactam with placebo
- First posted
- 2025-07-14
- Last updated
- 2025-09-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time in hours from first study-medication administration to normalization of all qSOFA parameters and decrease of peak CRP by 50%. | From date of randomization until the date of first documented normalization of qSOFA and 50% decrease in CRP. We estimate median time to be of approximately 108h and 96h in the control and intervention groups, respectively (approx 4 to 5 days) | qSOFA scores will be collected as per routine ward practices and at minimum every 2 hours for patients with abnormal scores, until normalization. CRP will be measured twice daily (12 ± 4 hours apart), for 6 days or until the 50% reduction from peak is observed, whichever occurs earlier. Thereafter, measurements will be taken as clinically indicated. |
| Secondary | Incidence of adverse events of special interest (AESI) | From day 1 to day 3 (+/-1 day) of intervention and up to 48h after the last administration of the study medication/placebo | Patients will be monitored post-randomization for the occurrence of adverse events of special interest (AESI), defined as follows: * New-onset pulmonary edema detected by imaging or auscultatory exam beginning during and up to 2 days after treatment with study antibiotic(s) * New-onset hypernatremia beginning during and up to 2 days after treatment with study antibiotic(s) * New-onset hypokalemia beginning during and up to 2 days after treatment with study antibiotic(s) * New-onset gastrointestinal events (abdominal pain, nausea, vomiting, and/or diarrhea) beginning during and up to 2 days after treatment with study antibiotic(s) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07063095
GET https://conductscience.org/api/trials/v1/NCT07063095/registered