Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters

Completed · Phase 3

Conditions studied: Infection

In brief

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 catheter colonization in patients who have central venous catheters.

Key facts

Study ID

NCT00231153

Run by

Cadence Pharmaceuticals

People needed

1859

Starts

2005-08-01

Expected to finish

2008-07-01

Last updated by the study team

2009-08-13

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Arcadia, California, United States
• Study site — Glendale, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Madera, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Torrance, California, United States
• Study site — Denver, Colorado, United States
• Study site — Bridgeport, Connecticut, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Fort Gordon, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Elk Grove Village, Illinois, United States
• Study site — Hoffman Estates, Illinois, United States
• Study site — Louisville, Kentucky, United States
• Study site — Opelousas, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — Camden, New Jersey, United States
• Study site — Newark, New Jersey, United States
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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