Antibiotic Prophylaxis When Removing Ureteric Stent After Stone Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by University Hospital, Akershus
Sponsor:
Information provided by (Responsible Party):
Tor Erik Sand, Akershus University College
ClinicalTrials.gov Identifier:
NCT01768364
First received: January 14, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

Is there anything to gain in giving antibiotics as prophylaxis when removing ureteric stents cystoscopically after stone surgery?


Condition Intervention
Ureteric Stent After Stone Surgery
Drug: Trimetoprim-Sulfa (Bactrim)
Other: No antibiotics

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University Hospital, Akershus:

Primary Outcome Measures:
  • 14 days infection rate w/wo antibiotics [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • infection rate with ureter stent wo antibiotics [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Study Start Date: January 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Antibiotics
will receive antibiotics
Drug: Trimetoprim-Sulfa (Bactrim)
Active Comparator: No antibiotics
will not receive antibiotics
Other: No antibiotics

Detailed Description:

Many patients undergoing stone surgery receive a ureteric stent that should be removed after 14 days. This stent is removed cystoscopically and today this is done without giving antibiotics. Some patients get urinary tract infections subject to this. However the investigators do not know how many of these patients get UTI as most are followed by their primary care doctor. With this study the investigators would like to find out whether it is possible to avoid such infections and also find out how many actually do get infected.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stone surgery patients with ureteric stent that should be removed after 14 days

Exclusion Criteria:

  • ongoing antibiotic treatment, allergy to trimetoprim-sulfa
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768364

Contacts
Contact: Tor Erik Sand, MD, PhD tor.erik.sand@ahus.no
Contact: Manuela Estop-Garanto, MD mnet@ahus.no

Locations
Norway
Akershus University Hospital Not yet recruiting
Lorenskog, Norway, 1478
Contact: Manuela Estop-Garanto, MD       mnet@ahus.no   
Contact: Tor Erik Sand, MD, PhD       tor.erik.sand@ahus.no   
Principal Investigator: Tor Erik Sand, MD, PhD         
Sponsors and Collaborators
Tor Erik Sand
Investigators
Principal Investigator: Tor Erik Sand, MD. PhD University Hospital, Akershus
  More Information

No publications provided

Responsible Party: Tor Erik Sand, Professor, M.D., Ph.D., Akershus University College
ClinicalTrials.gov Identifier: NCT01768364     History of Changes
Other Study ID Numbers: 2012/953
Study First Received: January 14, 2013
Last Updated: January 14, 2013
Health Authority: Norway: Ethics Committee

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on October 01, 2014