Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine

This study is currently recruiting participants.

Verified February 2013 by Wellspect HealthCare

Sponsor:

Information provided by (Responsible Party):

Wellspect HealthCare

ClinicalTrials.gov Identifier:

NCT01782404

First received: January 30, 2013

Last updated: February 1, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 30, 2013

Last Updated Date

February 1, 2013

Start Date ^ICMJE

January 2013

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of patients with bacteriuria <10^3 CFU/ml [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Bacteriuria will be followed by daily urinary cultures, 3 hours after morning irrigation. The proportion of patients with at least one sample <10^3 CFU/ml within the 7 day treatment period will be evaluated.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01782404 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time (number of days) to reduction of bacteriuria (<10^3 CFU/ml) [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Bacteriuria will be followed by daily urinary cultures, 3 hours after morning irrigation. The number of days until reduction of bacteriuria (<10^3 CFU/ml) will be evaluated. Maximum treatment period is 7 days.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine

Official Title ^ICMJE

Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine

Brief Summary

This a prospective, non-controlled, open, multi-center study evaluating the reduction of bacteriuria after bladder irrigation with chlorhexidine in spinal cord injured patients with chronic bacteriuria practicing intermittent catheterisation (IC). Patients will be treated with chlorhexidine for bladder irrigation twice daily for a maximum of 7 days.

The study hypothesis is that bladder irrigation with chlorhexidine is efficient for a short term reduction of bacteriuria in patients performing intermittent catheterization (IC).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Bacteriuria, Intermittent Catheterization

Intervention ^ICMJE

Device: Chlorhexidine

Bladder irrigation with chlorhexidine 0.2 mg/ml twice daily

Study Arm (s)

Experimental: Chlorhexidine

Intervention: Device: Chlorhexidine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria

Provision of informed consent
Female or male spinal cord injured subject aged 18 years and over
Bacteriuria of >10^5 CFU/mL of >1 bacterial species verified during screening visit
Regular users of intermittent catheterisation as primary method for bladder management (defined as a normal catheterisation frequency of at least 3 times daily for at least 1 month)
Ability to retain fluid in the bladder (approx. 120 ml) for at least 10 minutes, as judged by the investigator

Exclusion Criteria

Signs or symptoms of symptomatic UTI that requires treatment, as judged by the investigator.
Ongoing antibiotic treatment
Known anatomical pathology of the urinary tract that could compromise results, as judged by investigator
Subject with severe catheterisation difficulties, as judged by investigator
Known hypersensitivity to chlorhexidine
Use of other instillation products
Pregnancy
Use of medications that may affect the bacterial culture in the urine and bladder (e.g. methenamine hippurate)
Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
Previous enrolment or allocation of treatment in the present study.
Simultaneous participation in another clinical study that may interfere with the present study.
Severe non-compliance to protocol as judged by the investigator and/or Wellspect HealthCare

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Klara Thorsson

+46313764000

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT01782404

Other Study ID Numbers ^ICMJE

ABC-0008

Has Data Monitoring Committee

Not Provided

Responsible Party

Wellspect HealthCare

Study Sponsor ^ICMJE

Wellspect HealthCare

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lena Rutberg, MD

Sahlgrenska University Hospital, Sweden

Information Provided By

Wellspect HealthCare

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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