Overview

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

Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
0
Participant gender:
All
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 catheter colonization in patients who have central venous catheters.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cadence Pharmaceuticals
Mallinckrodt
Treatments:
Iodine
Povidone
Povidone-Iodine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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