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Non-antibiotic versus Antibiotic Prophylaxis for Recurrent Urinary Tract Infections.


- candidate number0
- NTR NumberNTR79
- ISRCTNISRCTN50717094
- Date ISRCTN created12-sep-2005
- date ISRCTN requested15-aug-2005
- Date Registered NTR15-jul-2005
- Secondary IDsProject 6200.0017 (ZonMw)  
- Public TitleNon-antibiotic versus Antibiotic Prophylaxis for Recurrent Urinary Tract Infections.
- Scientific TitleNon-antibiotic versus Antibiotic Prophylaxis for Recurrent Urinary Tract Infections.
- ACRONYMThe NAPRUTI-study.
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedUrinary tract infections
- Inclusion criteria1. 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 criteria1. Life expectancy 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-sep-2005
- planned closingdate1-sep-2009
- Target number of participants560
- InterventionsIn 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 outcome1. The numbers of recurrences of symptomatic UTI;
2. Time to first occurrence of antibiotic resistance in urine or faeces.
- Secondary outcome1. Incidence of other infections;
2. Incidence of asymptomatic bacteriuria events;
3. Quality of life;
4. Costs per prevented UTI.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. Mariëlle Beerepoot
- CONTACT for SCIENTIFIC QUERIESDr. S.E. Geerlings
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam, Academic Hospital Maastricht (AZM)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD11-aug-2005 - 8-dec-2006


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