Status:
COMPLETED
Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters
Lead Sponsor:
Cadence Pharmaceuticals
Conditions:
Infection
Eligibility:
All Genders
13+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether treatment with topical omiganan is more effective than treatment with topical povidone-iodine in preventing local catheter site infections and cathete...
Detailed Description
Study design: This is a phase 3, multi-center, randomized, Evaluation Committee-blinded study in patients undergoing noncuffed central venous catheterization using either a single lumen or multi-lume...
Eligibility Criteria
Inclusion
- New insertion of at least 1 noncuffed (nontunneled) temporary central venous catheter
- Males and females of at least 13 years of age
- A negative urine or serum pregnancy test at baseline
Exclusion
- Insertion of, or requirement for, any study catheter impregnated/bonded with an antimicrobial substance
- High probability of death within 14 days of enrollment as assessed by the investigator
- Prior treatment with vancomycin (intravenous administration only), daptomycin, linezolid, or quinupristin/dalfopristin, within 48 hours of first study catheter insertion or prior treatment with tigecycline within one week of first study catheter insertion
- Requirement for topical antibiotic use within 10 cm of any study catheterization site
- Known severe neutropenia (absolute neutrophil count \[ANC\] \< 500 mm3) or recent administration of antineoplastic therapy expected to result in severe neutropenia within 48 hours of first study catheter insertion
- Routine non-complicated coronary artery bypass grafting (CABG) patients, bone marrow transplant (BMT) or solid organ transplant (SOT) patients
- Patients anticipated to be catheterized for less than 48 hours
- Patients who have a suspected or known bloodstream infection at enrollment
- Burn patients or patients with toxic epidermal necrolysis
- Known allergy to adhesive tape or adhesive bandages
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
1859 Patients enrolled
Trial Details
Trial ID
NCT00231153
Start Date
August 1 2005
End Date
July 1 2008
Last Update
August 13 2009
Active Locations (57)
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Mobile, Alabama, United States
2
Phoenix, Arizona, United States
3
Arcadia, California, United States
4
Glendale, California, United States