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

• ClinicalTrials.gov Identifier: NCT00231153
• Recruitment Status: Completed
• First Posted: October 4, 2005
• Results First Posted: August 13, 2009
• Last Update Posted: August 13, 2009
• Sponsor: Cadence Pharmaceuticals
• Information provided by: Cadence

Tracking Information

• First Submitted Date: October 3, 2005
• First Posted Date: October 4, 2005
• Results First Submitted Date: June 30, 2009
• Results First Posted Date: August 13, 2009
• Last Update Posted Date: August 13, 2009
• Study Start Date: August 2005
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 30, 2009)

Local Catheter Site Infection (LCSI) [ Time Frame: study completion ]

LCSI was defined as a study catheter showing any 2 of the following criteria: erythema >= 2; edema >= 2; presence of purulence, pain, or abnormal study catheter site warmth. In addition, an action must have been taken that indicated a LCSI was present.

• Original Primary Outcome Measures (submitted: October 3, 2005): - To demonstrate the effectiveness of omiganan 1.0% gel compared to 10% povidone-iodine in preventing local catheter site infections in patients requiring at least one central venous catheter.

Current Secondary Outcome Measures (submitted: June 30, 2009)

• Microbiologically-confirmed LCSI [ Time Frame: study completion ]
  MCLCSI is a subset of EC-adjudicated LCSI for any catheter where there is (1) growth of a recognized pathogen from a culture or any purulence or exudate from the same insertion site, or (2) a positive culture of the subcutaneous segment of the catheter meeting criteria for significant colonization.
• Catheter Colonization (CC) [ Time Frame: study completion ]
  CC was defined as a positive culture of any catheter segment >= 15 CFU (roll-plate method) or >999 CFU/ml (sonication method) or a positive blood culture drawn via the catheter where the time-to-positivity difference of catheter line vs. peripheral blood >120 minutes (catheter positive first).

Original Secondary Outcome Measures (submitted: October 3, 2005)

• - clinically diagnosed LCSI or death
• - clinically diagnosed LCSI in the intent-to-treat (ITT) analysis set
• - microbiologically-confirmed LCSI
• - catheter-related bloodstream infections (CRBSI)
• - bloodstream infections (BSI)
• - catheter colonization

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Infection

Intervention

• Drug: 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.
• 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.

Study Arms

• Active Comparator: Povidone-Iodine 10%
  Intervention: Drug: Povidone-Iodine 10%
• Experimental: omiganan 1% gel
  Intervention: Drug: Omiganan 1% gel

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 28, 2008): 1859
• Original Enrollment (submitted: October 3, 2005): 1250
• Actual Study Completion Date: July 2008
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, Spain, United States

Administrative Information

• NCT Number: NCT00231153
• Other Study ID Numbers: CPI-226-03; EudraCT Number: 2005-003194-24
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Catherine Hardalo, MD. Vice President, Anti Infectives Clinical Development, Cadence Pharmaceuticals, Inc.
• Study Sponsor: Cadence Pharmaceuticals
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Cadence
• Verification Date: June 2009