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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Wellspect HealthCare
Sponsor:
Information provided by (Responsible Party):
Wellspect HealthCare
ClinicalTrials.gov Identifier:
NCT01782404
First received: January 30, 2013
Last updated: May 6, 2014
Last verified: May 2014

January 30, 2013
May 6, 2014
January 2013
August 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01782404 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine
Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine

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).

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bacteriuria, Intermittent Catheterization
Device: Chlorhexidine
Bladder irrigation with chlorhexidine 0.2 mg/ml twice daily
Experimental: Chlorhexidine
Intervention: Device: Chlorhexidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
22
Not Provided
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. Provision of informed consent
  2. Female or male spinal cord injured subject aged 18 years and over
  3. Bacteriuria of >10^5 CFU/mL of >1 bacterial species verified during screening visit
  4. 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)
  5. Ability to retain fluid in the bladder (approx. 120 ml) for at least 10 minutes, as judged by the investigator

Exclusion Criteria

  1. Signs or symptoms of symptomatic UTI that requires treatment, as judged by the investigator.
  2. Ongoing antibiotic treatment
  3. Known anatomical pathology of the urinary tract that could compromise results, as judged by investigator
  4. Subject with severe catheterisation difficulties, as judged by investigator
  5. Known hypersensitivity to chlorhexidine
  6. Use of other instillation products
  7. Pregnancy
  8. Use of medications that may affect the bacterial culture in the urine and bladder (e.g. methenamine hippurate)
  9. Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
  10. Previous enrolment or allocation of treatment in the present study.
  11. Simultaneous participation in another clinical study that may interfere with the present study.
  12. Severe non-compliance to protocol as judged by the investigator and/or Wellspect HealthCare
Both
18 Years and older
No
Contact: Klara Thorsson +46313764000
Sweden
 
NCT01782404
ABC-0008
Not Provided
Wellspect HealthCare
Wellspect HealthCare
Not Provided
Principal Investigator: Lena Rutberg, MD Sahlgrenska University Hospital, Sweden
Wellspect HealthCare
May 2014

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