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Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women.

NCT04959331 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-09-08

No results posted yet for this study

Summary

Randomized clinical trial in which women aged 18 or older and with symptoms of uncomplicated lower urinary tract infection and a positive urine dipstick analysis will be randomized to one of the following four groups: 2-day 3 g fosfomycin o.d., 3-day pivmecillinam 400 mg. t.i.d, 5-day nitrofurantoin 100 mg t.i.d. or a single dose of 3 g of fosfomycin. Sample: 1,000 patients. Two co-primary endpoints are considered: clinical effectiveness at day 7 and bacteriological eradication at day 14. Follow-up visits are scheduled at days 7 (phone call), 14 and 28 for assessing evolution. Urine samples will be collected in the three on-site visits and urine cultures performed.

Conditions

Interventions

DRUG

Fosfomycin Trometamol Salt

Fosfomycin 3 g 2 sachets, taken orally, once daily for two days

DRUG

Nitrofurantoin

Nitrofurantoin 50 mg pills, taken orally, two pills/8 hours, for five days

DRUG

Pivmecillinam

Pivmecillinam 400 mg pills. taken orally, one pill/8 hours, for three days

DRUG

Fosfomycin Trometamol Salt

Fosfomycin 3 g one sachet, taken orally, for one day

Sponsors & Collaborators

  • Balearic Islands Health Service (Ibsalut)

    collaborator OTHER

  • Instituto de Investigación Sanitaria Aragón

    collaborator OTHER

  • Gerencia de Atención Primaria, Madrid

    collaborator OTHER_GOV

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Principal Investigators

  • Rosa Morros, MD PhD · Pharmacist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2024-12-14
Completion
2024-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04959331 on ClinicalTrials.gov