Clinical trial NCT00231153: Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters
Official title: A Phase 3, Multicenter, Randomized, Evaluation Committee-Blinded Study to Assess the Efficacy of Topical Omiganan 1% Gel in Preventing Local Catheter Site Infections/Colonization in Patients Undergoing Central Venous Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection
Keywords: catheter site infection
catheter colonization
catheter related blood stream infection
patients with central venous catheters
Lead sponsor: Cadence
Sponsor class: UNKNOWN
First posted: 2005-10-04
Enrollment: 1859
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Local Catheter Site Infection (LCSI)
timeFrame: study completion
Secondary outcomes:
measure: Microbiologically-confirmed LCSI
timeFrame: study completion
measure: Catheter Colonization (CC)
timeFrame: study completion
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Arcadia
country: United States
state: California
city: Glendale
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Madera
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Torrance
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Fort Gordon
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Elk Grove Village
country: United States
state: Illinois
city: Hoffman Estates
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: Opelousas
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: St. Paul
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Camden
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Jamaica
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Oklahoma City
country: United States
state: Oklahoma
city: Pittsburgh
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: El Paso
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Morgantown
country: United States
state: Virginia
city: Bourg en Bresse
country: France
city: Brive la Gaillarde
country: France
city: La Roche sur Yon
country: France
city: Limoges
country: France
city: Montauban
country: France
city: Orleans
country: France
city: Pau
country: France
city: Poitiers
country: France
city: Tours
country: France
city: Halle
country: Germany
city: Jena
country: Germany
city: Leipzig
country: Germany
city: Regensburg
country: Germany
city: Alcalá de Henares
country: Spain
city: Barcelona
country: Spain
city: Cadiz
country: Spain
city: El Palmar (Murcia)
country: Spain
city: Las Palmas de Gran Canaria
country: Spain
city: Madrid
country: Spain
city: Palma de Mallorca
country: Spain
city: Sevilla
country: Spain
Study officials:
References: