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Sponsored by: |
Baylor College of Medicine |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00614679 |
The primary objective is to investigate the ability of systemic intravenous antibiotic plus antibiotic/anti-biofilm (i.e. N-acetylcysteine) lock catheter technique in eradicating uncomplicated catheter associated bacteremia and salvaging the infected vascular catheter. Secondary objectives include duration to clearance of bacteremia, future recurrence of bacteremia, need for catheter removal and death.
Condition | Intervention | Phase |
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End-Stage Renal Disease Hemodialysis Catheter-Associated Infection |
Drug: catheter lock solution consisting of N-acetylcystein, tigecycline and heparin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | A Novel Catheter Lock Solution for Treatment of Tunneled Hemodialysis Catheter-Associated Bacteremia |
Estimated Enrollment: | 20 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
single arm trial of experimental catheter lock solution
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Drug: catheter lock solution consisting of N-acetylcystein, tigecycline and heparin
N-acetylcystein 80 mg/ml, tigecycline 1 mg/ml, and heparin 2000 units/ml. This will be a 5 ml catheter lock solution
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Saima Aslam, MD | 713-791-1414 ext 5546 | saslam@bcm.tmc.edu |
United States, Texas | |
Michael E. DeBakey VA Medical Center | Recruiting |
Houston, Texas, United States, 77030 | |
Sub-Investigator: Barbara Trautmer, MD, PhD | |
Ben Taub General Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Saima Aslam, MD 713-791-1414 ext 5546 saslam@bcm.tmc.edu | |
The Methodist Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Venkat Ramanathan, MD 713-798-8350 ramanath@bcm.tmc.edu |
Responsible Party: | Baylor College of Medicine ( Rabih Darouiche ) |
Study ID Numbers: | H-17624 |
Study First Received: | February 11, 2008 |
Last Updated: | February 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00614679 |
Health Authority: | United States: Federal Government |
biofilm catheter lock solution catheter salvage |
Bacterial Infections Systemic Inflammatory Response Syndrome Renal Insufficiency Tigecycline Kidney Failure, Chronic Bacteremia Inflammation |
Calcium heparin Sepsis Urologic Diseases Renal Insufficiency, Chronic Kidney Diseases Heparin Kidney Failure |
Anti-Infective Agents Anti-Bacterial Agents Pathologic Processes |
Therapeutic Uses Infection Pharmacologic Actions |