Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters
Condition: Infection
MeSH terms: Infections; Communicable Diseases
Intervention: Omiganan 1% gel; Povidone-Iodine 10%
Intervention description: 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.
Intervention MeSH terms: Povidone-Iodine; Povidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1859.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No
Keywords: catheter site infection; catheter colonization; catheter related blood stream infection; patients with central venous catheters

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.
    

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