Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters
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
2 other identifiers
interventional
1,859
4 countries
57
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2005
Typical duration for phase_3
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 3, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
August 13, 2009
CompletedAugust 13, 2009
June 1, 2009
2.8 years
October 3, 2005
June 30, 2009
June 30, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Local Catheter Site Infection (LCSI)
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.
study completion
Secondary Outcomes (2)
Microbiologically-confirmed LCSI
study completion
Catheter Colonization (CC)
study completion
Study Arms (2)
Povidone-Iodine 10%
ACTIVE COMPARATORomiganan 1% gel
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
Unknown Facility
Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Arcadia, California, United States
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Glendale, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Madera, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Torrance, California, United States
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Denver, Colorado, United States
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Bridgeport, Connecticut, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Fort Gordon, Georgia, United States
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Marietta, Georgia, United States
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Elk Grove Village, Illinois, United States
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Hoffman Estates, Illinois, United States
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Louisville, Kentucky, United States
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Opelousas, Louisiana, United States
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Shreveport, Louisiana, United States
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Saint Paul, Minnesota, United States
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Kansas City, Missouri, United States
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Camden, New Jersey, United States
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Newark, New Jersey, United States
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Brooklyn, New York, United States
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Jamaica, New York, United States
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Syracuse, New York, United States
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Oklahoma City, Oklahoma, United States
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Pittsburgh, Pennsylvania, United States
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Memphis, Tennessee, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Morgantown, Virginia, United States
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Bourg-en-Bresse, France
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Brive-la-Gaillarde, France
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La Roche-sur-Yon, France
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Limoges, France
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Montauban, France
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Orléans, France
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Pau, France
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Poitiers, France
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Tours, France
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Halle, Germany
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Jena, Germany
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Leipzig, Germany
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Regensburg, Germany
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Alcalá de Henares, Spain
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Barcelona, Spain
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Cadiz, Spain
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El Palmar (Murcia), Spain
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Las Palmas de Gran Canaria, Spain
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Madrid, Spain
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Palma de Mallorca, Spain
Unknown Facility
Seville, Spain
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Catherine Hardalo, MD Vice President Anti-Infectives, Clinical Development
- Organization
- Cadence Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 3, 2005
First Posted
October 4, 2005
Study Start
August 1, 2005
Primary Completion
June 1, 2008
Study Completion
July 1, 2008
Last Updated
August 13, 2009
Results First Posted
August 13, 2009
Record last verified: 2009-06