Estudio en fase III, multicéntrico, aleatorizado, con enmascaramiento del tratamiento para el comité de evaluación para valorar la eficacia de la administración tópica de omiganán al 1,0% en gel en la prevención de infecciones locales en la zona del catéter y la colonización del catéter en pacientes que se someten a una cateterización venosa central.

Conditions: Prevención de infecciones en la zona del catéter.Prevention of local site infections in patients requiring central venous and/or arterial catheterization and/or peripherally inserted central venous catheterization (PICC).

Registration Number: EUCTR2005-003194-24-ES

Lead Sponsor: Cadence Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1250

Inclusion Criteria

All of the following criteria must be met for a patient to be eligible for the study:
1. New insertion of at least 1 noncuffed (nontunneled) temporary central venous catheter within 4 hours prior to randomization and for which the insertion site was disinfected using 10% povidone iodine for a minimum of 2 minutes prior to catheter placement . If a CVC and arterial line or PICC are being inserted simultaneously (within 30 minutes of each other), these patients will qualify for the study.
2. No CVC, PICC or arterial catheters in place at the time of insertion of first study catheter. Catheters that were removed within 48 hours of study randomization should be documented in the case report form (CRF).
3. Males and females of at least 13 years of age.
4. A negative urine or serum pregnancy test at baseline in women of child bearing potential.
5. Able to provide signed informed consent. If less than 18 years of age, written consent from both the patient and a legal guardian must be obtained.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients are excluded from the study if any of the following are met:
1. CVC in place for greater than 4 hours before randomization and application of study drug.
2. Insertion of, or requirement for, any study catheter impregnated/bonded with an antimicrobial substance.
3. High probability of death within 14 days of enrollment as assessed by the Investigator.
4. 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.
5. Requirement for topical antibiotic use within 10 cm of any study catheterization site.
6. Known severe neutropenia (ANC <500 mm3) or recent administration of antineoplastic therapy expected to result in severe neutropenia within 48 hours of first study catheter insertion.
7. Routine non-complicated coronary artery bypass grafting (CABG) patients, bone marrow transplant (BMT) or solid organ transplant (SOT) patients.
8. Patients who have been treated with any investigational drug within the previous 30 days.
9. Patients who are participating in an investigational drug study at any time during the course of this study.
10. Patients anticipated to be catheterized for less than 48 hours.
11. Patients who have a suspected or known bloodstream infection at enrollment.
12. Burn patients or patients with toxic epidermal necrolysis.
13. History of sensitivity to any ingredients in the study drugs.
14. Known allergy to adhesive tape or adhesive bandages.
15. Any evidence or history of illicit intravenous drug use within 4 weeks prior to the study, unless a transesophageal ultrasound has ruled out infective endocarditis
16. A medical condition that the Investigator believes may interfere with the safety of the patient or the intent and conduct of the study (such as severe eczema, psoriasis and/or dermal infections that would interfere with assessment of study endpoints).
17. Pregnant women.