Antibiotic Prophylaxis for Transrectal Prostate Biopsy-Ciprofloxacin vs. Trimethoprim/Sulfamethoxazole
NCT ID: NCT02734732
Last Updated: 2019-05-15
Study Results
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Basic Information
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UNKNOWN
PHASE2
2800 participants
INTERVENTIONAL
2015-04-30
2020-05-31
Brief Summary
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Detailed Description
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Aim: To evaluate the best antibiotic prophylaxis prior to trans rectal prostate biopsy in low risk patients.
Outcome: Hospitalization for infection within 14 days from biopsy.
Method: By randomization of all eligible patients with low risk of infectious complications. Patient and treating physician is blinded to treatment allocation. By using the nationwide and full coverage national patient register (NPR), mandatory for inpatient care4. All patients can be identified by the Swedish personal identification number5. Both patients related baseline characteristics is gathered through register linkages. To validate the outcome variables, for all patients admitted to hospital within 14 days will be subject for chart review. Comparing all patients from the participating units, having a code specific to trans rectal biopsy, and comparing to the excluded patients as well as included patients, will make a separate exclusion analysis.
The standard operating procedure for randomization is that patients will fill a form and informed consent of participation prior to the planned biopsy. If no exclusion criteria are filled and informed consent obtained, patient will be randomized through a web based randomization program, where only date of biopsy, earlier prostate biopsy, number of biopsies, PSA and prostate size is collected. Other baseline variables will be obtained by cross linkage to the NPR and the National Prostate Cancer Registry. A randomization number is given to all patients at this stage and a key code is established at each participating unit containing every patient randomization number and subsequent personal identification number.
After complete requirement, data will be collected at Västernorrlands Läns Landsting and analyzed according to protocol.
Analysis will be made by logistic regression and point estimates with Single sided 97.5% Confidence Interval. Sample size is calculated to require 2800 patients assuming a 0.5% frequency of infections, able to detect a difference of 0.75% in absolute proportion of infections.
Missing data on outcome variable, received treatment or date of biopsy will be excluded from analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Ciprofloxacin
T. Ciprofloxacin 750mg, single dose immediately prior to prostate biopsy
Ciprofloxacin
Trimethoprim/Sulfamethoxazole
Trimethoprim/Sulfamethoxazole 160mg/800mg immediately prior to prostate biopsy
Trimethoprim/Sulfamethoxazole
Interventions
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Trimethoprim/Sulfamethoxazole
Ciprofloxacin
Eligibility Criteria
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Inclusion Criteria
* Informed consent
Exclusion Criteria
* Indwelling urinary catheter
* Prior urinary infection (last 6 months)
* Dipstick positive (Nitrites test)
* Allergy to Ciprofloxacin or Trimethoprim/Sulfamethoxazole
* Severe liver disease
* Concomittant use of Tizanidine
* Immunosuppression
MALE
No
Sponsors
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Umeå University
OTHER
Responsible Party
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Principal Investigators
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Johan Styrke, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Umeå University
Locations
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Östersunds hospital
Östersund, Jämtland County, Sweden
Sundsvalls hospital
Sundsvall, Västernorrland County, Sweden
Ängelholm hospital
Ängelholm, , Sweden
Helsingborgs Hospital
Helsingborg, , Sweden
Umea University Hospital
Umeå, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Magbus Wagenius, M.D
Role: primary
Magnus Wagenius, M.D
Role: primary
References
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Isen K, Kupeli B, Sinik Z, Sozen S, Bozkirli I. Antibiotic prophylaxis for transrectal biopsy of the prostate: a prospective randomized study of the prophylactic use of single dose oral fluoroquinolone versus trimethoprim-sulfamethoxazole. Int Urol Nephrol. 1999;31(4):491-5. doi: 10.1023/a:1007115312039.
Lundstrom KJ, Drevin L, Carlsson S, Garmo H, Loeb S, Stattin P, Bill-Axelson A. Nationwide population based study of infections after transrectal ultrasound guided prostate biopsy. J Urol. 2014 Oct;192(4):1116-22. doi: 10.1016/j.juro.2014.04.098. Epub 2014 May 9.
Wagenlehner FM, Bartoletti R, Cek M, Grabe M, Kahlmeter G, Pickard R, Bjerklund-Johansen TE. Antibiotic stewardship: a call for action by the urologic community. Eur Urol. 2013 Sep;64(3):358-60. doi: 10.1016/j.eururo.2013.05.044. Epub 2013 May 29.
Ludvigsson JF, Andersson E, Ekbom A, Feychting M, Kim JL, Reuterwall C, Heurgren M, Olausson PO. External review and validation of the Swedish national inpatient register. BMC Public Health. 2011 Jun 9;11:450. doi: 10.1186/1471-2458-11-450.
Ludvigsson JF, Otterblad-Olausson P, Pettersson BU, Ekbom A. The Swedish personal identity number: possibilities and pitfalls in healthcare and medical research. Eur J Epidemiol. 2009;24(11):659-67. doi: 10.1007/s10654-009-9350-y. Epub 2009 Jun 6.
Other Identifiers
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2014---002999---83
Identifier Type: -
Identifier Source: org_study_id
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