Trial Outcomes & Findings for D Mannose in Recurrent Urinary Tract Infections (NCT NCT01808755)

NCT ID: NCT01808755

Last Updated: 2014-05-21

Results Overview

time required to develop the next urinary tract infection; evaluation by means of urine analysis and urine culture

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 60 participants
• Primary outcome timeframe: 168
• Results posted on: 2014-05-21

Participant Flow

60 female patients aged between 22 and 74 years were visited at the outpatient Clinic (July 2011-July 2012), they were eligible for study if they were 18 years old or older and had 3 or more culture documented urinary tract infections (UTI) in the preceding 12 months. Women were excluded from study if they had evidence of upper UTI

All patients before entering the trial were prescribed and followed a regimen of continuous, low-dose daily antibiotic prophylaxis at bedtime or post-coital prophylaxis with cotrimoxazole or ciprofloxacin, whenever the UTI occurred 24-48 hours after intercourse.

Participant milestones

Measure	D Mannose First, Then Trimethoprim/Sulfamethoxazole D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfametoxazole 80 mg + 400 mg twice a day; length of treatment: 5-7 days	Trimethoprim/Sulfamethoxazole First, Then D Mannose Antibiotic : trimethoprim/sulfametoxazole 80 mg + 400 mg twice a day; length of treatment: 5-7 days then D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

D Mannose in Recurrent Urinary Tract Infections

Baseline characteristics by cohort

Measure	All Study Participamts n=60 Participants D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfamethoxazole 160/800 mg; length of treatment: 5-7 days
Age, Continuous	42 years STANDARD_DEVIATION 22 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Italy	60 participants n=5 Participants
urinary tract infection <18 years	0 participants n=5 Participants
urinary tract infection Between 18 and 74 years	60 participants n=5 Participants
urinary tract infection >75 years	0 participants n=5 Participants
positive urine culture	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 168

time required to develop the next urinary tract infection; evaluation by means of urine analysis and urine culture

Outcome measures

Measure	D Mannose First, Then Trimethoprim /Sulfamethoxazole n=30 Participants 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfamethoxazole 160/800 mg; length of treatment: 5-7 days	Trimethoprim /Sulfamethoxazole First, Then D Mannose n=30 Participants trimethoprim/sulfametossazole 160/800 mg for 5-7 days then D Mannose 1 gr. every 8 hours for 2 weeks
Days	200 days Standard Deviation 50.7	52.7 days Standard Deviation 11.2

Adverse Events

D Mannose Versus Antibiotic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

D. Porru

Divisione Urologia IRCCS Policlinico San Matteo Pavia, Italy

Phone: 39-0382-503868/503872

Email: danieleporru@tin.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place