|- candidate number||0|
|- NTR Number||NTR79|
|- Date ISRCTN created||12-sep-2005|
|- date ISRCTN requested||15-aug-2005|
|- Date Registered NTR||15-jul-2005|
|- Secondary IDs||Project 6200.0017 (ZonMw) |
|- Public Title||Non-antibiotic versus Antibiotic Prophylaxis for Recurrent Urinary Tract Infections.|
|- Scientific Title||Non-antibiotic versus Antibiotic Prophylaxis for Recurrent Urinary Tract Infections.|
|- ACRONYM||The NAPRUTI-study.|
|- Healt Condition(s) or Problem(s) studied||Urinary tract infections|
|- Inclusion criteria||1. Women aged 18 years or older;|
2. At least 3 symptomatic urinary tract infections, uncomplicated or complicated, in the year preceding study inclusion OR already using any form of prophylaxis to prevent recurrences of urinary tract infections and at least 3 symptomatic urinary tract infections in the year befort the start of the prophylaxis.
|- Exclusion criteria||1. Life expectancy = 1 year;|
2. Legally incapable;
3. A renal transplant in the medical history;
4. Contraindications for or relevant interactions with TMP/SMX;
5. Additional exclusion criteria for trial A (pre-menopausal women randomized to either cranberry capsules or TMP/SMX);
6. Breastfeeding, pregnancy, or pregnancy wish for the next year;
7. Contraindications for or relevant interactions with cranberries.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-sep-2005|
|- planned closingdate||1-sep-2009|
|- Target number of participants||560|
|- Interventions||In trial A, 280 pre-menopausal women will receive either cranberry capsules (twice daily 500 mg) or standardized antibiotic treatment (once daily 480 mg trimethoprim-sulfamethoxazole = TMP/SMX).|
In trial B, 280 postmenopausal women will receive either lactobacilli oral therapy ( twice daily a capsule with >10e9 Lactobacillus rhamnosus GR-1 and L. reuteri RC-14) or standardized antibiotic treatment (480 mg TMP/SMX).
The “double-dummy”-method is used for blinding. Each patient receives 1 tablet and 2 capsules daily, but only one of them (the tablet or the capsules) contains the active substance. All study medication must be taken for the duration of 12 months.
During the treatment period and the three months after stopping the treatment (wash-out period), each month patients have to fill in a short questionnaire and collect urine, faeces and a vaginal swab for culturing.
|- Primary outcome||1. The numbers of recurrences of symptomatic UTI;|
2. Time to first occurrence of antibiotic resistance in urine or faeces.
|- Secondary outcome||1. Incidence of other infections;|
2. Incidence of asymptomatic bacteriuria
3. Quality of life;
4. Costs per prevented UTI.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. Mariëlle Beerepoot|
|- CONTACT for SCIENTIFIC QUERIES||Dr. S.E. Geerlings|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam, Academic Hospital Maastricht (azM)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||11-aug-2005 - 8-dec-2006|