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Multifaceted Treatment of Catheter-related Urinary Tract Infection

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ClinicalTrials.gov Identifier: NCT00732238
Recruitment Status : Completed
First Posted : August 11, 2008
Results First Posted : November 3, 2014
Last Update Posted : February 16, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
The specific objective of this clinical trial is to demonstrate that a multifaceted approach for treatment for catheter-related urinary tract infection (UTI) in patients with spinal cord injury is effective and feasible. We plan to test the following hypothesis: a multifaceted treatment approach that consists of immediate removal of the indwelling bladder catheter, selecting antibiotics based on the finding from a urine culture that is obtained through the newly inserted catheter, and a 5-day course of systemic antibiotics will effectively treat catheter-related infection that is limited to the lower urinary tract of patients with spinal cord injury.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Neurogenic Bladder Urinary Tract Infection Other: Shortened course of antibiotic therapy Other: Standard Therapy Phase 2

Detailed Description:

UTI is the most common infection in patients with spinal cord injury who require a catheter to drain urine from their bladder. These infections can cause serious medical complications, such as bloodstream infection, decreased kidney function, prolonged hospitalization, and add great cost. Unfortunately, the treatment of catheter-related urinary tract infection has not been standardized in this population in terms of:

  • the need to replace the indwelling catheter;
  • the necessity to provide antibiotic coverage against all organisms grown from urine cultures; and
  • the duration of antibiotic treatment.

The prevalent, though not scientifically well supported approach for treating catheter-related lower UTI in patients with spinal cord injury comprises the following:

  • Retaining the original bladder catheter in place upon diagnosis of infection because of the theoretical concern that removal of the infected catheter may potentially cause the infecting organism to move from the bladder to the bloodstream (bacteremia). This theoretical complication, however, is very unlikely and even if it does occur, the bacteria would only remain in the bloodstream for a very short period of time and would not have a significant impact on the patient. In contrast, we propose that immediate removal of the original indwelling bladder catheter with its film of protected bacteria can enhance resolution of UTI.
  • Providing antibiotic coverage against all organisms which grow from a urine culture that is obtained from the original indwelling bladder catheter. Although this source of urine culture is a sensitive method for identifying the organisms that are present in the urine, it suffers from poor specificity because it may yield the growth of some organisms that could have colonized the catheter (and, therefore, grown in a culture of urine obtained through that original catheter) but did not contribute to UTI. This issue is particularly problematic in patients with spinal cord injury because urine cultures in almost half of the cases of UTI in this population yield multiple bacteria. Therefore, we propose that collection of a urine culture while inserting the new bladder catheter would yield growth of only organisms that truly contribute to UTI and, therefore, obviate the need to administer unnecessary antibiotics to cover additional organisms that would grow only from urine cultures obtained through the original catheter.
  • Treatment with systemic antibiotics for 10 days. There exists, however, no prospective randomized clinical trials indicating that this duration of antibiotic therapy is optimal in patients with spinal cord injury. Since catheter-free, able-bodied patients with lower UTI are successfully treated with courses of antibiotics as short as 1-3 days, we propose that by removing the focus of infection (i.e. the original catheter) a 5-day course of systemic antibiotics would be sufficient for treating catheter-related lower UTI in patients with spinal cord injury.

The results of this research are expected to provide the following major benefits to veterans with spinal cord injury:

  • the multifaceted approach will provide highly effective treatment of UTI;
  • the lower number of antibiotics that are administered to cover the organisms grown from urine cultures obtained at the time of inserting the replacement bladder catheter will result in lower cost of treatment and a reduced risk for developing antibiotic resistance;
  • the shorter duration of antibiotic course will decrease the overall cost of treatment, reduce hospital stay, and shorten rehabilitation down time.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multifaceted Treatment of Catheter-related Urinary Tract Infection
Study Start Date : July 2007
Primary Completion Date : December 2012
Study Completion Date : December 2012

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1
Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.
Other: Shortened course of antibiotic therapy
By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse.
Active Comparator: Arm 2
Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.
Other: Standard Therapy
Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter.

Outcome Measures

Primary Outcome Measures :
  1. The Primary Efficacy Outcome of the Study is Response to Treatment Which Will be Assessed at the End of Therapy. Successful Response to Treatment is Defined as Resolution of Clinical Manifestations of Infection Plus Lack of Growth of the Original Infect [ Time Frame: Patients will be evaluated for signs of continued infection at mid therapy and at the end of antibiotic therapy (day 5 for new catheter arm and day 10 for existing catheter arm) ]

Secondary Outcome Measures :
  1. The Secondary Efficacy Outcome is Recurrence of UTI up to 180 Days After the End of Therapy [ Time Frame: Up to 180 days of end of therapy ]
    Relapse of UTI is defined as a recurrence of clinical manifestations of infection plus growth of the original infecting pathogen(s) in urine culture in association with significant pyuria (>10 WBC/phf)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients with SCI who are hospitalized at the Michael E. Debakey VA Medical Center and suffer from lower UTI associate with an indwelling transurethral or suprapubic bladder catheter will be enrolled in the study

Exclusion Criteria:

  • Exclusion criteria will include septicemia, chronic antimicrobial therapy and inability, or unwillingness to give informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732238

United States, Texas
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Rabih O Darouiche, MD Michael E. DeBakey VA Medical Center (152)
More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00732238     History of Changes
Other Study ID Numbers: B4747-P
H-18309 ( Other Grant/Funding Number: Baylor College of Medicine )
First Posted: August 11, 2008    Key Record Dates
Results First Posted: November 3, 2014
Last Update Posted: February 16, 2015
Last Verified: January 2015

Keywords provided by VA Office of Research and Development:
Spinal Cord Injury
Urinary Tract Infection
Catheter Dependent

Additional relevant MeSH terms:
Communicable Diseases
Spinal Cord Injuries
Urinary Tract Infections
Urinary Bladder, Neurogenic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Urologic Diseases
Neurologic Manifestations
Urinary Bladder Diseases
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents