A randomized, double blind, double dummy, parallel group, multicenter clinical trial to evaluate the safety and clinical and microbiologic efficacy of oral fosfomycin calcium in adult womwn wiA th uUTI

Status

Not yet recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518646-24-00

Acronym

EfFoCa2021

Enrollment

384

Registered

2024-12-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated urinary tract infection (uUTI)

Brief summary

Clinical (resolution of symptoms of uUTI) and microbiological response (bacterial pathogen reduced to <1000 CFU/mL in urine culture) in the microbiological -ITT population obtained at TOC VISIT

Detailed description

Proportion of subjects with continued clinical and microbiologic success assessed at Visit 1 (TOC visit)

Interventions

DRUGFOSFOMYCIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Clinical (resolution of symptoms of uUTI) and microbiological response (bacterial pathogen reduced to <1000 CFU/mL in urine culture) in the microbiological -ITT population obtained at TOC VISIT	—

Secondary

Measure	Time frame
Proportion of subjects with continued clinical and microbiologic success assessed at Visit 1 (TOC visit)	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026