Fosfomycin Trometamol Compared With an Alternative Active Antibiotic as Step-down Therapy for the Treatment of Acute Pyelonephritis Due to Escherichia Coli in Elderly Women : a Randomized, Multicenter, Non-inferiority Trial
NCT07928063, Phase 3, Not yet recruiting, Assistance Publique - Hôpitaux de Paris
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Fosfomycin Trometamol Compared With an Alternative Active Antibiotic as Step-down Therapy for the Treatment of Acute Pyelonephritis Due to Escherichia Coli in Elderly Women : a Randomized, Multicenter, Non-inferiority Trial | ClinicalTrials.gov |
| NCT number | NCT07928063 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 312 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris | ClinicalTrials.gov |
| Conditions | Escherichia Coli Infection, Elderly Women, Antibiotherapy, Pyelonephritis | ClinicalTrials.gov |
| Interventions | Fosfomycin-trometamol (FT), Alternative antibiotic treatment | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Clinical resolution | Day 17 | Clinical cure defined as : * Body temperature \< 38 °C and resolution of all urinary symptoms present at the time of the APN diagnosis, with no occurrence of new clinical signs (urinary urgency, dysuria, increased urinary frequency, gross hematuria, painful/burningurination, flank pain \[spontaneous or provoked\], suprapubic pain, or urinary incontinence) between treatment discontinuation and assessment of the primary endpoint at Day 17, except for a temperature ≥ 38°C unrelated to a urinary tract condition * No resumption of antibiotic therapy active against the causative pathogen responsible for the APN following completion of the antibiotic treatment course | ClinicalTrials.gov |
| Secondary | Occurence of antibiotic-related adverse events | Up to 37 days | Occurrence, nature, and severity of antibiotic-related adverse events, assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale. | ClinicalTrials.gov |
| Secondary | Occurence of geriatric complications | Up to 37 days | * Occurrence of delirium, defined according the Confusion Assessment Method (CAM) * Fall(s) (one or more episodes) * Weight loss, assessed as the percentage change between admission body weight and discharge body weight or Day 17 weight if the patient remains hospitalized * Occurrence of pressure ulcers, staged according to the National Pressure Ulcer Advisory Panel (NPUAP) pressure ulcer staging classification (HAS Guidelines, Prevention and Treatment of Pressure Ulcers in Adults and Older Persons, 2001) | ClinicalTrials.gov |
| Secondary | Functional autonomy | Up to 37 days | According to the Activities of Daily Living (ADL) scale: score ranges from 0 (complete dependence) to 6 (complete independence), with higher scores indicating greater independence in basic daily activities such as bathing, dressing, toileting, transferring and eating. | ClinicalTrials.gov |
| Secondary | Incidence of Infectious and urological complications | Up to day 7 | * Renal abscess (yes/no) * Need for urinary drainage * Transfer to an continuous care unit or intensive care unit due to the infection At the end of antibiotic treatment (Day 7) | ClinicalTrials.gov |
| Secondary | Cumulative incidence of recurrent febrile or non-febrile urinary tract infectious (UTIs) (relapse or reinfection) | From Day 17 to Day 37 | * Cystitis : recurrence of urinary symptoms in the absence of fever, associated with a positive urine culture. * Acute pyelonephritis :; recurrence of urinary symptoms with fever and a positive urine culture. * Reinfection : new infection caused by a microorganism different from that isolated during the initial episode. * Relapse : recurrence of infection due to the same microorganism as that isolated during the initial episode. | ClinicalTrials.gov |
| Secondary | Rate of hospitalization or rehospitalization following treatment for APN | Up to day 37 | ClinicalTrials.gov | |
| Secondary | Length of hospital stay following randomization | Up to day 37 | ClinicalTrials.gov | |
| Secondary | All-cause mortality | Up to day 37 | ClinicalTrials.gov | |
| Secondary | Rate of rectal colonization with antibiotic-resistant Enterobacterales | Up to day 37 | fluoroquinolones, trimethoprim-sulfamethoxazole, fosfomycin, and third-generation cephalosporins | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)