Cystitis urinary tract infection
Conditions
Interventions
I. Fosfomycin-trometamol (FT)
o Single dose scheme: 3000mg taken orally once (arm A)
o Extended dosing scheme: 3000mg taken orally on day 1 and day 3 (arm B)
II. Nitrofurantoin
o 100mg b.i.d. in slo
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Adult women (>
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Duration of cystitis symptoms defined as *the number of days with full resolution of relevant cystitis symptoms within the period of 28 days in the absence of aggravation to pyelonephritis or urosepsis (see definition for the secondary endpoint below)*. Relevant symptoms of cystitis include: o Dysuria o Urgency o Frequency of miction o suprapubic tenderness | — |
Secondary
| Measure | Time frame |
|---|---|
| * Rate of clinical failure, defined as new or persisting cystitis symptoms or aggravation to pyelonephritis or urosepsis for which a new antibiotic treatment was prescribed within 28 days * Rate of microbiological failure at day 28 (26 to 30) defined as persistence of the initial infecting organism (* 103 colony forming units (cfu) /ml) * Rate of pyelonephritis or urosepsis, defined as the occurrence of signs or symptoms of pyelonephritis or urosepsis (fever, flank pain, or other matching symptoms) for which antibiotic treatment was prescribed* * Rate of relapses at day 28, defined as clinical failure caused by the initial infecting organism (> 103 cfu /ml) * Rate of reinfections at day 28, defined as clinical failure caused by another organism than the initial infecting organism * Rate of mortality (all-cause) * Rate of hospital admission (all-cause) * Duration of adverse events symptoms (including diarrhea, nausea, abdominal cramps, increased vaginal discharge or other). * Incidence and nature of severe adverse events, see chapter 9 for definitions * Rate of complete self-reported therapy adherence after 7 days * Satisfaction with the treatment received after 28 days on a scale of 5 * The rate of emergence of antibiotic resistance to fosfomycin and nitrofurantoin * Correlation between in vivo and in vitro activity for the different antibiotic arms * The number of days of absenteeism: o education o (voluntary) work | — |
Countries
Netherlands
Outcome results
None listed