At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 1,859 enrolled

Drug / intervention

Omiganan 1% gel +1 moredrug

Likely dose

Omiganan 1% gel applied topically to catheter insertion site, reapplied every 3 days with dressing changeAI-extracted

Key inclusion· 3

✓New insertion of at least 1 noncuffed (nontunneled) temporary central venous catheter
✓Males and females of at least 13 years of age
✓Negative urine or serum pregnancy test at baseline

Key exclusion· 10

✕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 IV vancomycin, daptomycin, linezolid, or quinupristin/dalfopristin within 48 hours, or tigecycline within 1 week of catheter insertion
✕Requirement for topical antibiotic use within 10 cm of any study catheterization site

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00231153

NCT00231153Phase 3Completed

Compare CT.gov

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

Cadence Pharmaceuticals·interventional·Posted Oct 4, 2005·Updated Aug 13, 2009

In Brief

A Phase 3 clinical trial evaluating Omiganan 1% gel and Povidone-Iodine 10% for Infection. Completed, enrolled 1,859 participants across 57 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfection

CountriesFrance, Germany, Spain, United States

Collaborators--

Timeline

Phase 3CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartAug 2005

First PostedOct 2005

Primary CompletionJun 2008

Study CompletionJul 2008

TodayJul 2026

First PostedOct 4, 2005

Enrollment StartAug 1, 2005

Primary CompletionJun 1, 2008

Study CompletionJul 1, 2008

TodayJul 2, 2026

Enrollment to primary: 2.8 yearsPosted 20.7 years ago

Interventions

Omiganan 1% geldrug

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.

Povidone-Iodine 10%drug

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.