Phase 3
N=1,815
Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters
Infection
Bottom Line
View on ClinicalTrials.gov: NCT00231153 ↗Enrolled (actual)
1,815
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Local Catheter Site Infection (LCSI) — 50; 70 Events — p=0.082
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omiganan 1% gel (Drug); Povidone-Iodine 10% (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Cadence Pharmaceuticals
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Catheter Site Infection (LCSI) |
50; 70 | 0.082 |
| SECONDARY Microbiologically-confirmed LCSI |
31; 62 | 0.002 sig |
| SECONDARY Catheter Colonization (CC) |
369; 478 | <0.001 sig |
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
Data sourced from ClinicalTrials.gov (NCT00231153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.