NCT02734732

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,800

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2015

Longer than P75 for phase_2

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 6, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

5 years

First QC Date

April 6, 2016

Last Update Submit

May 14, 2019

Conditions

Prostate Infection

Keywords

ProstateBiopsyInfectionProphylaxisAntibiotic

Outcome Measures

Primary Outcomes (1)

  • Admitted to hospital due to infection

    Admission to hospital within 14 days from biopsy

    14 days

Secondary Outcomes (8)

  • Filled antibiotic prescription

    Within 30 days

  • Positive urinary or blood culture

    Within 30 days

  • Any hospital admission

    Within 14 days

  • Overall Mortality

    Within 90 days

  • Bacteriological characteristics

    Within 30 days

  • +3 more secondary outcomes

Study Arms (2)

Ciprofloxacin

ACTIVE COMPARATOR

T. Ciprofloxacin 750mg, single dose immediately prior to prostate biopsy

Drug: Ciprofloxacin

Trimethoprim/Sulfamethoxazole

ACTIVE COMPARATOR

Trimethoprim/Sulfamethoxazole 160mg/800mg immediately prior to prostate biopsy

Drug: Trimethoprim/Sulfamethoxazole

Interventions

Trimethoprim/SulfamethoxazoleDRUG
Trimethoprim/Sulfamethoxazole
CiprofloxacinDRUG
Ciprofloxacin

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Östersunds hospital

Östersund, Jämtland County, 83130, Sweden

NOT YET RECRUITING

Sundsvalls hospital

Sundsvall, Västernorrland County, Sweden

RECRUITING

Ängelholm hospital

Ängelholm, 26281, Sweden

NOT YET RECRUITING

Helsingborgs Hospital

Helsingborg, 25187, Sweden

NOT YET RECRUITING

Umea University Hospital

Umeå, 90185, Sweden

RECRUITING

Related Publications (5)

  • 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.

    PMID: 10668944BACKGROUND

  • 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.

    PMID: 24813343BACKGROUND

  • 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.

    PMID: 23746854BACKGROUND

  • 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.

    PMID: 21658213BACKGROUND

  • 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.

    PMID: 19504049BACKGROUND

MeSH Terms

Conditions

Infections

Interventions

Trimethoprim, Sulfamethoxazole Drug CombinationCiprofloxacin

Intervention Hierarchy (Ancestors)

SulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Johan Styrke, M.D, Ph.D

    Umeå University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Styrke, M.D, Ph.D

CONTACT

0046-60181000johan.styrke@umu.se

Karl-Johan Lundström, M.D

CONTACT

0046-704941642karl-johan.lundstrom@jll.se

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2016

First Posted

April 12, 2016

Study Start

April 1, 2015

Primary Completion

April 1, 2020

Study Completion

May 1, 2020

Last Updated

May 15, 2019

Record last verified: 2019-05

Locations

SE(5)