Antibiotic Prophylaxis for Transrectal Prostate Biopsy-Ciprofloxacin vs. Trimethoprim/Sulfamethoxazole
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| ClinicalTrials.gov Identifier: NCT02734732 |
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Recruitment Status : Unknown
Verified May 2019 by Umeå University.
Recruitment status was: Recruiting
First Posted : April 12, 2016
Last Update Posted : May 15, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Infection | Drug: Trimethoprim/Sulfamethoxazole Drug: Ciprofloxacin | Phase 2 |
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 2020 |
| Estimated Study Completion Date : | May 2020 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Ciprofloxacin
T. Ciprofloxacin 750mg, single dose immediately prior to prostate biopsy
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Drug: Ciprofloxacin |
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Active Comparator: Trimethoprim/Sulfamethoxazole
Trimethoprim/Sulfamethoxazole 160mg/800mg immediately prior to prostate biopsy
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Drug: Trimethoprim/Sulfamethoxazole |
- Admitted to hospital due to infection [ Time Frame: 14 days ]Admission to hospital within 14 days from biopsy
- Filled antibiotic prescription [ Time Frame: Within 30 days ]A filled prescription within 14 days from biopsy
- Positive urinary or blood culture [ Time Frame: Within 30 days ]A positive urinary or blood culture obtained within 14 days from biopsy
- Any hospital admission [ Time Frame: Within 14 days ]Admission to hospital within 14 days from biopsy, regardless of cause
- Overall Mortality [ Time Frame: Within 90 days ]Overall mortality within 90 days from biopsy
- Bacteriological characteristics [ Time Frame: Within 30 days ]Resistance patterns and species of bacteria in blood or urinary cultures within 14 days from biopsy
- Hospitalisation time [ Time Frame: Within 14 days ]Number of days admitted to hospital
- Total doses of antibiotics filled [ Time Frame: Within 30 days ]The total amount of antibiotics filled
- 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 |
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
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
| 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 |
| 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 | |
| Principal Investigator: | Johan Styrke, M.D, Ph.D | Umeå University |
| Responsible Party: | Umeå University |
| ClinicalTrials.gov Identifier: | NCT02734732 |
| Other Study ID Numbers: |
2014---002999---83 |
| First Posted: | April 12, 2016 Key Record Dates |
| Last Update Posted: | May 15, 2019 |
| Last Verified: | May 2019 |
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Prostate Biopsy Infection Prophylaxis Antibiotic |
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Infections Ciprofloxacin Trimethoprim Sulfamethoxazole Anti-Bacterial Agents Anti-Infective 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 Anti-Dyskinesia Agents Cytochrome P-450 CYP2C8 Inhibitors |