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

Recruitment & Eligibility

Status: Suspended

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
-Urine collection is performed according to the Dutch NHG-guideline

Exclusion Criteria

-Presence of signs of tissue invasion according to NHG guideline: fever, malaise, chills, flank or perineal pain, signs of sepsis or delirium
-Pregnancy or nursing*
-Diabetes Mellitus
-Immunocompromised state:
oUntreated infection with human immunodeficiency virus (hiv)
oUse of high-dose systemic corticosteroids
oUse of other immunosuppressive medication
-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 (current or in past 28 days)with nitrofurantoin or fosfomycin or trimethoprim.
-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
-Previous inclusion in EXFOCY
-Presence of urine cultures showing resistance for nitrofurantoin or fosfomycin in the last 12 months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of days with full resolution of cystitis symptoms within the period of 28 days

Secondary Outcome Measures

Name	Time	Method
•Rate of clinical failure within 28 days, irrespective the causing organism<br>•Rate of microbiological failure at day 28 <br>•Rate of relapses at day 28, <br>•Rate of reinfections at day 28<br>•Rate of aggravation to pyelonephritis or urosepsis at day 28 <br>•Rate of hospital admission at day 28<br>•Rate of mortality at day 28<br>•Incidence of (severe) adverse events (including fever, diarrhea, nausea, vaginitis, headache, dizziness) on day 7<br>•Self-reported therapy adherence on day 7<br>•Satisfaction with the treatment received after 28 days<br>•The number of days of absenteeism (from payed work or volunteer work) <br>•Correlation between in vivo and in vitro activity for the investigational treatments