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the Use of Fosfomycin as a Single Dose Oral Treatment of Asymptomatic Bacteriuria

NCT03548129 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2018-06-07

No results posted yet for this study

Summary

Urinary tract infections (UTIs) are the most commonly occurring bacterial infections in women, Asymptomatic bacteriuria (AB) is a common complication during pregnancy, with a prevalence of 2-10%. It has been associated with a greater incidence of symptomatic urinary tract infection (UTI), as well as foetal and obstetric complications. Appropriate treatment reduces the incidence of UTI by 80-90%, as well as the risk of a premature birth and low-birth-weight baby Fosfomycin trometamol (Monuril) is approved in numerous countries worldwide, including various European countries and the USA, mainly for the treatment of uncomplicated UTIs

Conditions

Interventions

DRUG

phosphomycin

Single dose 3 gm oral fosfomycin will be taken by mouth on an empty stomach

DRUG

Culture specific antibiotic therapy

Culture-specific antibiotic treatment for 5 days

DIAGNOSTIC_TEST

Pre-treatment Urine Culture

Mid-stream urine sample will be cultured and number of CFU per mL will be determined.

DIAGNOSTIC_TEST

Antimicrobial sensitivity testing

Susceptibility of urinary pathogens to various antimicrobials

DIAGNOSTIC_TEST

Post-treatment urine culture

Mid-stream urine sample will be cultured and number of CFU per mL will be determined.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Mohamed Samy, MD · M Samy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-07-31
Completion
2018-08-31

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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 NCT03548129 on ClinicalTrials.gov