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

Phase 4

Completed

Conditions: Cystitis
urinary tract infection
10004018
10046590

Registration Number: NL-OMON50944

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 777

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

Exclusion Criteria

-Pregnancy or nursing
-Diabetes Mellitus
-Immunocompromised state
o Untreated infection with human immunodeficiency virus (hiv)
o Use of high-dose systemic corticosteroids
o Use 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Duration of cystitis symptoms defined as the number of days with full<br /><br>resolution of relevant cystitis symptoms within the period of 28 days in the<br /><br>absence of aggravation to pyelonephritis or urosepsis (see definition for the<br /><br>secondary endpoint below). Relevant symptoms of cystitis include:<br /><br>o Dysuria<br /><br>o Urgency<br /><br>o Frequency of miction<br /><br>o suprapubic tenderness</p><br>

Secondary Outcome Measures