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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR79 |
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Date of registration:
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15/07/2005 |
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Primary sponsor: |
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Public title:
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Non-antibiotic versus Antibiotic Prophylaxis for Recurrent Urinary Tract Infections.
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Scientific title:
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Non-antibiotic versus Antibiotic Prophylaxis for Recurrent Urinary Tract Infections. - The NAPRUTI-study. |
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Date of first enrolment:
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1/9/2005 |
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Target sample size:
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560 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=79 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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S.E.
Geerlings |
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Address:
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Academic Medical Center (AMC), Department of Infectious diseases,
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5664380 |
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Email:
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S.E.Geerlings@amc.uva.nl |
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Affiliation:
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Name:
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Mariëlle
Beerepoot |
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Address:
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Academic Medical Center (AMC), Department of Infectious diseases, Tropical Medicine and AIDS,
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5667921 |
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Email:
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M.A.Beerepoot@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Urinary tract infections
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Intervention(s)
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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.
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Primary Outcome(s)
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1. The numbers of recurrences of symptomatic UTI;
2. Time to first occurrence of antibiotic resistance in urine or faeces.
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Secondary Outcome(s)
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1. Incidence of other infections;
2. Incidence of asymptomatic bacteriuria
events;
3. Quality of life;
4. Costs per prevented UTI.
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Secondary ID(s)
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ISRCTN50717094
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Project 6200.0017 (ZonMw)
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development
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