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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00231153
• Date of registration: 03/10/2005
• Prospective Registration: No
• Primary sponsor: Mallinckrodt
• Public title: Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters
• Scientific 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
• Date of first enrolment: August 2005
• Target sample size: 1859
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00231153
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

France, Germany, Spain, United States

Key inclusion & exclusion 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



Age minimum: 13 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Infection

Intervention(s)

Drug: Povidone-Iodine 10%

Drug: Omiganan 1% gel

Primary Outcome(s)

Local Catheter Site Infection (LCSI) [Time Frame: study completion]

Secondary Outcome(s)

Microbiologically-Confirmed LCSI [Time Frame: study completion]

Catheter Colonization (CC) [Time Frame: study completion]

Secondary ID(s)

EudraCT Number: 2005-003194-24

CPI-226-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/08/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00231153