EXtended use of FOsfomycin for the treatment of CYstitis in primary care

Phase 1

• Conditions: ncomplicated cystitis is defined as a lower urinary tract infection in adult women (above 18 years of age) without risk factors for a complicated course, i.e. pregnancy, Diabetes Mellitus, functional or anatomical deficits of the urologic tract or immunosuppression.; MedDRA version: 20.0Level: PTClassification code 10011781Term: CystitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2020-005337-33-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-24
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 741

Inclusion Criteria

-Adult women (>18 years of age) with a diagnosis of uncomplicated cystitis in primary care
-Cystitis diagnosis is according to the flow diagram in the Dutch NHG-guideline. In line with the NHG guideline 2020, recognition of symptoms should always be accompanied with either a positive nitrite test or leucocyte and dipslide test

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 241

Exclusion Criteria

-Pregnancy
-Diabetes Mellitus
-Immunocompromised state
oUntreated infection with human immunodeficiency virus (hiv)
oUse of high-dose systemic corticosteroids
oUse of other immunosuppressive medication (specified in protocol)
-Presence of an indwelling urinary catheter
-History of abnormalities in urinary tract or kidneys
-Neurogenic bladder dysfunction
-UTI in past 28 days before inclusion
-Antibiotic prophylaxis in past 28 days with nitrofurantoin or fosfomycin
-Known GFR <30mL/min
-Contra-indication for nitrofurantoin or fosfomycin use (e.g. allergic reactions, lung or liver reaction or peripheral neuropathy after previous use in clinical history, acute porphyria, G6PD deficiency)
-Current use of an antibiotic for any reason

Study & Design

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