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

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ClinicalTrials.gov Identifier: NCT02734732
Recruitment Status : Unknown
Verified April 2016 by Umeå University.
Recruitment status was:  Recruiting
First Posted : April 12, 2016
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
Umeå University

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.

Condition or disease Intervention/treatment Phase
Prostate Infection Drug: Trimethoprim/Sulfamethoxazole Drug: Ciprofloxacin Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Antibiotic Prophylaxis for Transrectal Prostate Biopsy-Ciprofloxacin vs. Trimethoprim/Sulfamethoxazole
Study Start Date : April 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : May 2017


Arm Intervention/treatment
Active Comparator: Ciprofloxacin
T. Ciprofloxacin 750mg, single dose immediately prior to prostate biopsy
Drug: Ciprofloxacin
Active Comparator: Trimethoprim/Sulfamethoxazole
Trimethoprim/Sulfamethoxazole 160mg/800mg immediately prior to prostate biopsy
Drug: Trimethoprim/Sulfamethoxazole



Primary Outcome Measures :
  1. Admitted to hospital due to infection [ Time Frame: 14 days ]
    Admission to hospital within 14 days from biopsy


Secondary Outcome Measures :
  1. Filled antibiotic prescription [ Time Frame: Within 30 days ]
    A filled prescription within 14 days from biopsy

  2. Positive urinary or blood culture [ Time Frame: Within 30 days ]
    A positive urinary or blood culture obtained within 14 days from biopsy

  3. Any hospital admission [ Time Frame: Within 14 days ]
    Admission to hospital within 14 days from biopsy, regardless of cause

  4. Overall Mortality [ Time Frame: Within 90 days ]
    Overall mortality within 90 days from biopsy

  5. Bacteriological characteristics [ Time Frame: Within 30 days ]
    Resistance patterns and species of bacteria in blood or urinary cultures within 14 days from biopsy

  6. Hospitalisation time [ Time Frame: Within 14 days ]
    Number of days admitted to hospital

  7. Total doses of antibiotics filled [ Time Frame: Within 30 days ]
    The total amount of antibiotics filled

  8. Risk factors for infection [ Time Frame: Within 30 days ]
    Other risk factors for infection apart from exclusion criteria, in baseline variables



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734732


Contacts
Contact: Johan Styrke, M.D, Ph.D 0046-60181000 johan.styrke@umu.se
Contact: Karl-Johan Lundström, M.D 0046-704941642 karl-johan.lundstrom@jll.se

Locations
Sweden
Östersunds hospital Not yet recruiting
Östersund, Jämtland, Sweden, 83130
Contact: Karl-Johan Lundström       karl_johan@hotmail.com   
Sundsvalls hospital Recruiting
Sundsvall, Västernorrland, Sweden
Contact: Johan Styrke, MD    0046-70-2992048    johan.styrke@umu.se   
Helsingborgs Hospital Not yet recruiting
Helsingborg, Sweden, 25187
Contact: Magnus Wagenius, M.D         
Umea University Hospital Recruiting
Umea, Sweden, 90185
Contact: Jon Fridriksson, MD       jon.fridriksson@umu.se   
Ängelholm hospital Not yet recruiting
Ängelholm, Sweden, 26281
Contact: Magbus Wagenius, M.D         
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Johan Styrke, M.D, Ph.D Umeå University

Publications:
Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT02734732     History of Changes
Other Study ID Numbers: 2014--‐002999--‐83
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016

Keywords provided by Umeå University:
Prostate
Biopsy
Infection
Prophylaxis
Antibiotic

Additional relevant MeSH terms:
Anti-Bacterial Agents
Ciprofloxacin
Antibiotics, Antitubercular
Trimethoprim
Sulfamethoxazole
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Cytochrome P-450 CYP2C8 Inhibitors