Alternatives to prophylactic antibiotics for the treatment of recurrent urinary tract infection in wome

Phase 1

• Conditions: Recurrent urinary tract infection in women; MedDRA version: 18.1Level: PTClassification code 10064736Term: Antibiotic prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-003487-36-GB
• Lead Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-07
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• Women aged 18 years and over.

• Women with rUTI who, in consultation with a clinician, have decided that prophylaxis is an appropriate option (to include women who have suffered at least three episodes of symptomatic UTI within the preceding 12 months or two episodes in the last 6 months or a single severe infection requiring hospitalisation).

• Able to take a once daily oral dose of at least one of nitrofurantoin, or trimethoprim, or cephalexin.

• Able to take Methenamine hippurate.

• Women who agree to take part in the trial but who are already taking Methenamine or antibiotic prophylaxis will be consented for participation and will stop their preventative therapy for a 3-month washout period. They will then be reassessed and if still eligible undergo baseline assessment and randomisation.

• Able to give informed consent for participation in trial.

• Able and willing to adhere to an 18-month study period.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

• Women unable to take Methenamine hippurate e.g. known allergy to Methenamine hippurate, severe hepatic impairment (Childs –Pugh class C, score of 10 or more, see appendix 4), gout, eGFR < 10 ml/min, Proteus sp. as consistent proven causative organism for rUTIs.

• Women who are unable to take nitrofurantoin and trimethoprim and cephalexin.

• Women with correctable urinary tract abnormalities that are considered to be contributory to the occurrence of rUTI.

• Presence of symptomatic UTI – this will be treated and symptoms resolved prior to randomisation.

• Pregnancy or intended pregnancy in next 12 months.

• Women who are breast feeding.

• Women already taking methenamine or antibiotic prophylaxis and declining a 3-month washout period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified