Trial · NCT07902427
Oral Fosfomycin as Sequential Oral Treatment for Multidrug-Resistant Escherichia Coli in Acute Bacterial Prostatitis
NCT07902427, Phase 4, Completed, Hospital Mutua de Terrassa
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral Fosfomycin as Sequential Oral Treatment for Multidrug-Resistant Escherichia Coli in Acute Bacterial Prostatitis. Trials, record NCT07902427. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07902427
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Fosfomycin as Sequential Oral Treatment for Multidrug-Resistant Escherichia Coli in Acute Bacterial Prostatitis
- NCT number
- NCT07902427
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 88 participants, actual
- Lead sponsor
- Hospital Mutua de Terrassa
- Conditions
- Prostatitis, Escherichia Coli Infection
- Interventions
- Fosfomycin Trometamol Salt, control group, control group
- First posted
- 2026-10-28
- Last updated
- 2026-10-28
- Other registries' IDs
- eudract:2019-003792-19
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Clinical Cure | Day 21 ± 3 days from treatment initiation (end of treatment) | Clinical cure was defined as the resolution of all symptoms present at baseline without the need for additional antibiotic treatment. Clinical cure required the absence of fever (axillary temperature greater than 38°C), urinary symptoms (dysuria, urinary frequency, urgency, or suprapubic pain), and altered level of consciousness if present at baseline. |
| Primary | Percentage of Participants With Microbiological Cure | Day 21 ± 3 days from treatment initiation (end of treatment). | Microbiological cure was defined as a negative urine culture at the end of antibiotic treatment. Only participants with an available urine culture at the end-of-treatment assessment were included in the analysis of this outcome. Participants without an available urine culture were excluded from the microbiological cure analysis. |
| Secondary | Estimated Carbapenem Defined Daily Doses (DDDs) Avoided per Patient | During the 21-day antibiotic treatment period. | The potential carbapenem-sparing effect of sequential oral fosfomycin trometamol was estimated in patients with acute bacterial prostatitis caused by multidrug-resistant Escherichia coli. Assuming that these patients would otherwise have received intravenous ertapenem until completion of the planned 21-day antibiotic course, the number of potentially avoided ertapenem Defined Daily Doses (DDDs) was calculated based on the remaining treatment duration after switching to oral fosfomycin. Results were expressed as estimated DDDs avoided per patient. |
| Secondary | Hospital Length of Stay in Days | During the hospital admission for the acute bacterial prostatitis episode. | Hospital length of stay was assessed as the number of days of actual hospital admission during the acute bacterial prostatitis episode and compared between the fosfomycin and control group. In accordance with the study protocol, patients with hospital-acquired multidrug-resistant Escherichia coli infection were excluded from this analysis |
| Secondary | Estimated Hospitalization Days Avoided per Patient | During the 21-day antibiotic treatment period | The potential reduction in hospital or hospital-at-home admission days associated with sequential oral fosfomycin trometamol was estimated among patients receiving oral fosfomycin. Assuming that these patients would otherwise have required continued parenteral antibiotic therapy during hospital or hospital-at-home admission, the number of potentially avoided admission days was estimated from the remaining days of the planned 21-day antibiotic treatment course after switching to oral fosfomycin. Results were expressed as estimated admission days avoided per patient. |
| Secondary | Plasma Fosfomycin Concentration | At 1, 2, 4, 12, and 24 hours after the first oral fosfomycin dose; additional trough concentrations during hospitalization or at Visit 4, as applicable. | Plasma fosfomycin concentrations (mg/L) were planned to be measured using blood samples collected at predefined time points after oral fosfomycin trometamol administration in selected participants at the coordinating center. The planned pharmacokinetic assessment was not performed, and no plasma fosfomycin concentration data were collected. |
| Secondary | Percentage of Participants Experiencing Adverse Events | From treatment initiation through Day 51 (± 7 days). | The incidence and severity of adverse events were assessed in patients receiving sequential oral fosfomycin trometamol or conventional oral antibiotic therapy. Adverse events were recorded during antibiotic treatment and subsequent follow-up through Day 51 (± 7 days) from treatment initiation. Results were expressed as the number and percentage of participants experiencing adverse events in each treatment group, with assessment of their severity. |
| Secondary | Acute Bacterial Prostatitis-Related Mortality | From treatment initiation through Day 51 (± 7 days). | Mortality related to the acute bacterial prostatitis episode was assessed in both treatment groups. The outcome was measured as the number and percentage of participants who died from causes attributable to the acute bacterial prostatitis episode during the study observation period. |
| Secondary | Incidence of Acute Bacterial Prostatitis Recurrence | From completion of antibiotic treatment through Day 51 (± 7 days) from treatment initiation. | The incidence of acute bacterial prostatitis relapse or reinfection was assessed prospectively during the protocol-defined follow-up period. Relapse was defined as recurrence of urinary tract infection symptoms with isolation of the same microorganism, whereas reinfection was defined as recurrence of symptoms with isolation of a different bacterial strain. Results were expressed as the number and percentage of participants experiencing relapse or reinfection in each treatment group. |
| Secondary | Incidence of Emergent Fosfomycin Resistance | From treatment initiation through Day 51 (± 7 days). | The emergence of fosfomycin resistance was planned to be assessed through microbiological susceptibility testing during treatment and follow-up in participants receiving oral fosfomycin trometamol. This assessment was not performed, and no data on emergent fosfomycin resistance were collected. |
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.
Papers19
The papers the trial lists on ClinicalTrials.gov.
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/NCT07902427
GET https://conductscience.org/api/trials/v1/NCT07902427/registered