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

NCT ID: NCT00231153

Last Updated: 2009-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1859 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2008-07-31

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 catheter colonization in patients who have central venous catheters.

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-lumen catheter, and for whom the catheter is expected to be in place for at least 48 hours and for no longer than 28 days. Patients will be randomized within 4 hours of the insertion of the first study CVC.

The first study catheter for all patients must be a noncuffed (nontunneled) central venous catheter (CVC). Additionally, only catheters inserted using povidone iodine to prepare the insertion site are eligible to become study catheters. CVCs will be inserted either into the axillary, jugular, subclavian, or femoral vein. Following the first study CVC insertion, additional CVCs, as well as arterial catheters and PICC lines will be allowed as study catheters. Only catheters that have not been impregnated with an antimicrobial substance (e.g. bonded catheters, antimicrobial impregnated, silver tipped, etc) may be used as study catheters. Study catheters must have a skin/catheter interface; for example, introducers will be allowed as study catheters but any catheter, including a CVC, inserted through the introducer will be deemed a non-study catheter. Once a patient has been randomized to either treatment, all study catheters will receive the same treatment.

NIH (NCID) and/or local hospital guidelines will be followed for maximal sterile barrier precautions. The catheter site will be disinfected using 10% povidone iodine for a minimum of 2 minutes per established CDC guidelines prior to catheter insertion. Patients randomized to the omiganan 1% gel group will receive an application of omiganan 1% gel around the catheter insertion site following catheter insertion. Patients randomized to the povidone iodine group will receive no further antisepsis treatment other than cleansing the site with povidone iodine at dressing changes. For patients in both groups, the catheterization site will be covered with a semitransparent dressing provided by the sponsor.

Every 3 days the dressing will be changed. Skin irritation, erythema and edema will be assessed as well as the presence of purulence, moisture, ecchymosis, abnormally warm tissue temperature and/or site pain/tenderness.

Patients will be discharged from the study following the removal of the final study catheter or on study day 28, whichever is sooner. Patients or their legal representatives will be contacted at least 28 days after study discharge/withdrawal for safety follow-up purposes.

Conditions

Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Povidone-Iodine 10%

Group Type: ACTIVE_COMPARATOR

Povidone-Iodine 10%

Intervention Type: DRUG

All CVC sites will be disinfected using a 10% povidone-iodine scrub for a minimum of 2 minutes prior to catheter insertion. Patients randomized to the povidone-iodine group will receive no further antiseptic treatment after catheter insertion until dressing changes. Every three days the dressing will be changed and the catheter site will be sterilized with povidone-iodine.

omiganan 1% gel

Group Type: EXPERIMENTAL

Omiganan 1% gel

Intervention Type: DRUG

Patients randomized to omiganan group will receive an application of omiganan gel around the catheter insertion site following catheter insertion. Every 3 days the dressing will be changed and patients will receive a new application of Omiganan 1% gel.

Interventions

Omiganan 1% gel

Patients randomized to omiganan group will receive an application of omiganan gel around the catheter insertion site following catheter insertion. Every 3 days the dressing will be changed and patients will receive a new application of Omiganan 1% gel.

Intervention Type: DRUG

Povidone-Iodine 10%

All CVC sites will be disinfected using a 10% povidone-iodine scrub for a minimum of 2 minutes prior to catheter insertion. Patients randomized to the povidone-iodine group will receive no further antiseptic treatment after catheter insertion until dressing changes. Every three days the dressing will be changed and the catheter site will be sterilized with povidone-iodine.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cadence Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Cadence Pharmaceuticals, Inc.

Locations

Mobile, Alabama, United States

Phoenix, Arizona, United States

Arcadia, California, United States

Glendale, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Madera, California, United States

San Diego, California, United States

San Francisco, California, United States

Torrance, California, United States

Denver, Colorado, United States

Bridgeport, Connecticut, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Fort Gordon, Georgia, United States

Marietta, Georgia, United States

Elk Grove Village, Illinois, United States

Hoffman Estates, Illinois, United States

Louisville, Kentucky, United States

Opelousas, Louisiana, United States

Shreveport, Louisiana, United States

Saint Paul, Minnesota, United States

Kansas City, Missouri, United States

Camden, New Jersey, United States

Newark, New Jersey, United States

Brooklyn, New York, United States

Jamaica, New York, United States

Syracuse, New York, United States

Oklahoma City, Oklahoma, United States

Pittsburgh, Pennsylvania, United States

Memphis, Tennessee, United States

El Paso, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

Lubbock, Texas, United States

Morgantown, Virginia, United States

Bourg-en-Bresse, , France

Brive-la-Gaillarde, , France

La Roche-sur-Yon, , France

Limoges, , France

Montauban, , France

Orléans, , France

Pau, , France

Poitiers, , France

Tours, , France

Halle, , Germany

Jena, , Germany

Leipzig, , Germany

Regensburg, , Germany

Alcalá de Henares, , Spain

Barcelona, , Spain

Cadiz, , Spain

El Palmar (Murcia), , Spain

Las Palmas de Gran Canaria, , Spain

Madrid, , Spain

Palma de Mallorca, , Spain

Seville, , Spain

Countries

United States; France; Germany; Spain

Other Identifiers

EudraCT Number: 2005-003194-24

Identifier Type: -

Identifier Source: secondary_id

CPI-226-03

Identifier Type: -

Identifier Source: org_study_id