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:
Wellspect HealthCare
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
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Bacteriuria, Intermittent Catheterization |
Device: Chlorhexidine |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine |
Resource links provided by NLM:
Further study details as provided by Wellspect HealthCare:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 22 |
| Study Start Date: | January 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Chlorhexidine |
Device: Chlorhexidine
Bladder irrigation with chlorhexidine 0.2 mg/ml twice daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782404
Contacts
| Contact: Klara Thorsson | +46313764000 |
Locations
| Sweden | |
| Spinal Cord Injury Unit, Sahlgrenska University Hospital | Recruiting |
| Göteborg, Sweden, 413 45 | |
| Spinal Cord Injury Unit, Skåne University Hospital | Recruiting |
| Höör, Sweden | |
| Spinal Cord Injury Unit, Linköping University Hospital | Recruiting |
| Linköping, Sweden | |
Sponsors and Collaborators
Wellspect HealthCare
Investigators
| Principal Investigator: | Lena Rutberg, MD | Sahlgrenska University Hospital, Sweden |
More Information
No publications provided
| Responsible Party: | Wellspect HealthCare |
| ClinicalTrials.gov Identifier: | NCT01782404 History of Changes |
| Other Study ID Numbers: | ABC-0008 |
| Study First Received: | January 30, 2013 |
| Last Updated: | February 1, 2013 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Additional relevant MeSH terms:
|
Bacteriuria Urinary Tract Infections Infection Urologic Diseases Chlorhexidine Chlorhexidine gluconate |
Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Disinfectants Dermatologic Agents |
ClinicalTrials.gov processed this record on May 19, 2013