Status:
TERMINATED
EXtended Use of FOsfomycin for the Treatment of CYstitis in Primary Care
Lead Sponsor:
MJM Bonten
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Saltro
Conditions:
Urinary Tract Infections
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Cystitis is the most frequent reason for women to visit their general practitioner. More than 600.000 women suffer from urinary tract infections in The Netherlands each year. Currently, the 1st choice...
Detailed Description
1. INTRODUCTION AND RATIONALE Cystitis is the most common problem in primary care in the Netherlands for women (3.7% of all consultations in women).0 Women are disproportionally affected with abou...
Eligibility Criteria
Inclusion
- Adult women (\>18 years of age) with a diagnosis of uncomplicated cystitis in primary care
Exclusion
- 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
- Untreated infection with human immunodeficiency virus (hiv)
- Use of high-dose systemic corticosteroids
- Use of other immunosuppressive medication (see table below)
- 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
Key Trial Info
Start Date :
September 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05254808
Start Date
September 6 2021
End Date
February 14 2022
Last Update
March 15 2022
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Medisch Centrum Heuvelrug
Doorn, Utrecht, Netherlands, 3941 ZE
2
Huisartsenpraktijk Mariahoek
Utrecht, Netherlands, 3511 GK
3
Huisartsenpraktijk Binnenstad
Utrecht, Netherlands, 3512 VS
4
UMC Utrecht
Utrecht, Netherlands, 3584 CX