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

This study has been completed.
Sponsor:
Information provided by:
Cadence Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00231153
First received: October 3, 2005
Last updated: June 30, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Infection
Drug: Omiganan 1% gel
Drug: Povidone-Iodine 10%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Cadence Pharmaceuticals:

Primary Outcome Measures:
  • Local Catheter Site Infection (LCSI) [ Time Frame: study completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Microbiologically-Confirmed LCSI [ Time Frame: study completion ] [ Designated as safety issue: No ]
  • Catheter Colonization (CC) [ Time Frame: study completion ] [ Designated as safety issue: No ]

Enrollment: 1859
Study Start Date: August 2005
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Povidone-Iodine 10% 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.
Experimental: omiganan 1% gel 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.

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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231153

  Show 57 Study Locations
Sponsors and Collaborators
Cadence Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Catherine Hardalo, MD. Vice President, Anti Infectives Clinical Development, Cadence Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00231153     History of Changes
Other Study ID Numbers: CPI-226-03, EudraCT Number: 2005-003194-24
Study First Received: October 3, 2005
Results First Received: June 30, 2009
Last Updated: June 30, 2009
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Cadence Pharmaceuticals:
catheter site infection
catheter colonization
catheter related blood stream infection
patients with central venous catheters

Additional relevant MeSH terms:
Infection
Communicable Diseases
Povidone
Povidone-Iodine
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 22, 2014