CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
trimethoprim/sulfamethoxazole +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01808755
NCT01808755Phase 3Completed

Recurrent Urinary Tract Infections in Adult Women: a Pilot Study With Oral D Mannose

Fondazione IRCCS Policlinico San Matteo di Pavia·interventional·Posted Mar 11, 2013·Updated May 21, 2014

In Brief

A Phase 3 clinical trial evaluating D Mannose and trimethoprim/sulfamethoxazole for Recurrent Urinary Tract Infection. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Background- In recurrent urinary tract infections (RUTIs) usual prophylactic antibiotic regimes do not change the long term risk of recurrence. Objective- D-Mannose is a sugar, it sticks to E. coli bacteria, the aim of the study was to evaluate its efficacy in the treatment and prophylaxis of recurrent UTIs. Design, setting and participants- : In this crossover trial female patient were eligible for the study if they had recurrent UTIs, that is three ore more episodes during the preceding 12 months. Suitable patients were randomly assigned to antibiotic treatment with trimethoprim/sulfamethoxazole or to a regimen of oral D Mannose for 24 weeks, and received the other intervention in the second phase of the study. Outcome measurements and statistical analysis- The time to recurrence of UTI, bladder pain (VAS p) and urinary urgency (VAS u) were evaluated at the end of antibiotic therapy and at the and of 24 weeks fo D Mannose. The results for quantitative variables were expressed as mean values and SD as they were all normally distributed (Shapiro-Wilk test). T-test for paired data was used to analyze differences of time of recurrence, VAS pain, Vas urgency and number of voidings between treatment. Data analysis was performed with STATA statistical package (release 11,1, 2010, Stata Corporation, College Station, Texas, USA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2013
Enrollment StartJan 1, 2012
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.3 years ago

Interventions

D Mannosedietary

1 gr. every 8 hours

trimethoprim/sulfamethoxazoledrug

one cp b.i.d. for 5 days. Then one week of antibiotic every 4 weeks for the following 23 weeks