Antibiotic Prophylaxis for Transrectal Prostate Biopsy-Ciprofloxacin vs. Trimethoprim/Sulfamethoxazole

Prostate Infection Clinical Trial

Official title:

Antibiotic Prophylaxis for Transrectal Prostate Biopsy-Ciprofloxacin vs. Trimethoprim/Sulfamethoxazole

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02734732
• Other study ID #: 2014---002999---83
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2015
• Est. completion date: May 2020

Study information

• Verified date: May 2019
• Source: Umeå University
• Contact: Johan Styrke, M.D, Ph.D
• Phone: 0046-60181000
• Email: johan.styrke[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2800
• Est. completion date: May 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Infection

Intervention

Drug:
• Trimethoprim/Sulfamethoxazole

• Ciprofloxacin

Locations

Country	Name	City	State
Sweden	Ängelholm hospital	Ängelholm
Sweden	Helsingborgs Hospital	Helsingborg
Sweden	Östersunds hospital	Östersund	Jämtland
Sweden	Sundsvalls hospital	Sundsvall	Västernorrland
Sweden	Umea University Hospital	Umea

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

Isen K, Küpeli B, Sinik Z, Sözen 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. — View 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. — View 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. — View Citation

Lundström 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Admitted to hospital due to infection	Admission to hospital within 14 days from biopsy	14 days
Secondary	Filled antibiotic prescription	A filled prescription within 14 days from biopsy	Within 30 days
Secondary	Positive urinary or blood culture	A positive urinary or blood culture obtained within 14 days from biopsy	Within 30 days
Secondary	Any hospital admission	Admission to hospital within 14 days from biopsy, regardless of cause	Within 14 days
Secondary	Overall Mortality	Overall mortality within 90 days from biopsy	Within 90 days
Secondary	Bacteriological characteristics	Resistance patterns and species of bacteria in blood or urinary cultures within 14 days from biopsy	Within 30 days
Secondary	Hospitalisation time	Number of days admitted to hospital	Within 14 days
Secondary	Total doses of antibiotics filled	The total amount of antibiotics filled	Within 30 days
Secondary	Risk factors for infection	Other risk factors for infection apart from exclusion criteria, in baseline variables	Within 30 days