Prostate InfectionPhase 2NCT02734732
Antibiotic Prophylaxis for Transrectal Prostate Biopsy-Ciprofloxacin vs. Trimethoprim/Sulfamethoxazole
A Phase 2 study testing Trimethoprim/Sulfamethoxazole and Ciprofloxacin in people with Prostate Infection, run by Umeå University at 5 sites in Sweden.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Infection
- What is being tested?
- Trimethoprim/Sulfamethoxazole and Ciprofloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,800 participants
- Where
- 5 sitesSweden
- Study dates
- Apr 2015to May 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Indication for trans rectal prostate biopsy (Physicians discretion)
- Informed consent
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites, 5 recruiting
- Not yet recruiting
Ängelholm hospital
Ängelholm, 26281
Magbus Wagenius, M.D
- Not yet recruiting
Helsingborgs Hospital
Helsingborg, 25187
Magnus Wagenius, M.D
- Not yet recruiting
Östersunds hospital
Östersund, Jämtland County, 83130
Karl-Johan Lundström, karl_johan@hotmail.com
- Recruiting
Sundsvalls hospital
Sundsvall, Västernorrland County
Johan Styrke, MD, 0046-70-2992048, johan.styrke@umu.se
- Recruiting
Umea University Hospital
Umeå, 90185
Jon Fridriksson, MD, jon.fridriksson@umu.se
About this study
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.
Read the 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.
- Conditions
- Prostate Infection
- Being tested
- Trimethoprim/Sulfamethoxazole, Ciprofloxacin
- Keywords
- Prostate, Biopsy, Infection, Prophylaxis, Antibiotic
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimethoprim/SulfamethoxazoleDrug
CiprofloxacinDrug
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin | Active comparator | T. Ciprofloxacin 750mg, single dose immediately prior to prostate biopsy Receives: Drug: Ciprofloxacin |
| Trimethoprim/Sulfamethoxazole | Active comparator | Trimethoprim/Sulfamethoxazole 160mg/800mg immediately prior to prostate biopsy Receives: Drug: Trimethoprim/Sulfamethoxazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admitted to hospital due to infection
Admission to hospital within 14 days from biopsy
Measured: 14 days
Secondary outcomes (8)
Filled antibiotic prescription
A filled prescription within 14 days from biopsy
Measured: Within 30 days
Positive urinary or blood culture
A positive urinary or blood culture obtained within 14 days from biopsy
Measured: Within 30 days
Any hospital admission
Admission to hospital within 14 days from biopsy, regardless of cause
Measured: Within 14 days
Overall Mortality
Overall mortality within 90 days from biopsy
Measured: Within 90 days
Bacteriological characteristics
Resistance patterns and species of bacteria in blood or urinary cultures within 14 days from biopsy
Measured: Within 30 days
Hospitalisation time
Number of days admitted to hospital
Measured: Within 14 days
Total doses of antibiotics filled
The total amount of antibiotics filled
Measured: Within 30 days
Risk factors for infection
Other risk factors for infection apart from exclusion criteria, in baseline variables
Measured: Within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startApr 2015
- Primary completionApr 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prostate InfectionStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan Styrke, M.D, Ph.D, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734732
- Sponsor's protocol ID
- 2014---002999---83
- Other IDs
- 2014
- Status last verified
- May 2019
- First submitted
- 6 Apr 2016
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10668944Lundstrom 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.
PubMed 24813343Wagenlehner 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.
PubMed 23746854Ludvigsson 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.
PubMed 21658213Ludvigsson 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.
PubMed 19504049
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis for Transrectal Prostate Biopsy-Ciprofloxacin vs. Trimethoprim/Sulfamethoxazole
- ClinicalTrials.gov ID
- NCT02734732
- Acronym / sponsor ID
- 2014---002999---83
- Conditions
- Prostate Infection
- Keywords
- Prostate, Biopsy, Infection, Prophylaxis, Antibiotic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin | Active comparator | Drug: CiprofloxacinT. Ciprofloxacin 750mg, single dose immediately prior to prostate biopsy |
| Trimethoprim/Sulfamethoxazole | Active comparator | Drug: Trimethoprim/SulfamethoxazoleTrimethoprim/Sulfamethoxazole 160mg/800mg immediately prior to prostate biopsy |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for trans rectal prostate biopsy (Physicians discretion)
- Informed consent
Key exclusion criteria (8 listed)
- Diabetes Mellitus
- Indwelling urinary catheter
- Prior urinary infection (last 6 months)
- Dipstick positive (Nitrites test)
- Allergy to Ciprofloxacin or Trimethoprim/Sulfamethoxazole
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trimethoprim/Sulfamethoxazole | Drug | Trimethoprim/Sulfamethoxazole |
| Ciprofloxacin | Drug | Ciprofloxacin |
Primary outcome
Admitted to hospital due to infection
Time frame: 14 days
Admission to hospital within 14 days from biopsy
8 secondary outcomes
Filled antibiotic prescription
Time frame: Within 30 days
Positive urinary or blood culture
Time frame: Within 30 days
Any hospital admission
Time frame: Within 14 days
Overall Mortality
Time frame: Within 90 days
Bacteriological characteristics
Time frame: Within 30 days
Hospitalisation time
Time frame: Within 14 days
Total doses of antibiotics filled
Time frame: Within 30 days
Risk factors for infection
Time frame: Within 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Background: PubMed 10668944Isen 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.
- Background: PubMed 24813343Lundstrom 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.
- Background: PubMed 23746854Wagenlehner 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.
- Background: PubMed 21658213Ludvigsson 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.
- Background: PubMed 19504049Ludvigsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Styrke, M.D, Ph.D principal investigator
Umeå University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trimethoprim/Sulfamethoxazole and Ciprofloxacin in people with Prostate Infection, run by Umeå University at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan Styrke, M.D, Ph.D (0046-60181000, johan.styrke@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admitted to hospital due to infection (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02734732, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.