Clinical trial NCT02734732: Antibiotic Prophylaxis for Transrectal Prostate Biopsy-Ciprofloxacin vs. Trimethoprim/Sulfamethoxazole
Official title: Antibiotic Prophylaxis for Transrectal Prostate Biopsy-Ciprofloxacin vs. Trimethoprim/Sulfamethoxazole
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Infection
Keywords: Prostate
Biopsy
Infection
Prophylaxis
Antibiotic
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 2800
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will examine if a single dose of Ciprofloxacin and Trimethoprim/Sulfamethoxazole are equivalent for prophylaxis immediately prior to prostate biopsy, when a patient has a suspected prostate cancer.

Detailed description: Background: The number of prostate biopsies are estimated to approximately 1.000.000 each year I Europe1. The infection rates after transrectal prostate biopsy are increasing annually2. The most common antibiotic used for prophylaxis is Ciprofloxacin, however, Trimethoprim/Sulfamethoxazole is also a feasible alternative3.

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.

Eligibility criteria: Inclusion Criteria:

* Indication for trans rectal prostate biopsy (Physicians discretion)
* Informed consent

Exclusion Criteria:

* Diabetes Mellitus
* 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

Primary outcomes:
measure: Admitted to hospital due to infection
timeFrame: 14 days
Secondary outcomes:
measure: Filled antibiotic prescription
timeFrame: Within 30 days
measure: Positive urinary or blood culture
timeFrame: Within 30 days
measure: Any hospital admission
timeFrame: Within 14 days
measure: Overall Mortality
timeFrame: Within 90 days
measure: Bacteriological characteristics
timeFrame: Within 30 days
measure: Hospitalisation time
timeFrame: Within 14 days
measure: Total doses of antibiotics filled
timeFrame: Within 30 days
measure: Risk factors for infection
timeFrame: Within 30 days
Other outcomes:
Locations:
city: Östersund
country: Sweden
facility: Östersunds hospital
state: Jämtland
city: Sundsvall
country: Sweden
facility: Sundsvalls hospital
state: Västernorrland
city: Helsingborg
country: Sweden
facility: Helsingborgs Hospital
city: Umea
country: Sweden
facility: Umea University Hospital
city: Ängelholm
country: Sweden
facility: Ängelholm hospital
Study officials:
affiliation: Umeå University
name: Johan Styrke, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.