Assess the Efficacy of OM-89 vs Placebo in Reducing Antibiotic Consumption Associated With the Treatment of Urinary Tract Infections in Patients With Neurogenic Bladder

PHASE3RecruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

December 16, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
Neurogenic Bladder
Interventions
DRUG

OM-89 [Uro-Vaxom® Capsule]

1st phase and 2nd phase : 1 capsule per day of OM-89 for 90 consecutive days followed by a period of 90 days without treatment, then one capsule per day of OM-89 for 10 consecutive days each month for three months.

DRUG

OM-89 [Uro-Vaxom® Capsule] OM-89 placebo [Uro-Vaxom® Capsule placebo]

"1st phase: 1 capsule per day of placebo for 90 consecutive days followed by a period of 90 days without treatment, then one capsule per day of placebo for 10 consecutive days each month for three months.~Then 2nd phase: 1 capsule a day of OM-89, for 90 consecutive days followed by a period of 90 days without treatment, then one capsule a day of OM-89 6mg for 10 consecutive days each month for three months."

Trial Locations (1)

21000

RECRUITING

CHU Dijon Bourgogne, Dijon

All Listed Sponsors
lead

Centre Hospitalier Universitaire Dijon

OTHER