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

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ClinicalTrials.gov Identifier: NCT00231153
Recruitment Status : Completed
First Posted : October 4, 2005
Results First Posted : August 13, 2009
Last Update Posted : August 13, 2009
Sponsor:
Information provided by:
Cadence

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Infection
Interventions Drug: Omiganan 1% gel
Drug: Povidone-Iodine 10%
Enrollment 1859
Recruitment Details A total of 1859 hospitalized patients in the US and EU who required new insertion of short-term central venous catheter were enrolled. Study recruitment began in August 2005 and was completed in April 2008.
Pre-assignment Details Patients were randomized within 4 hours of insertion of the first study CVC. There were a total of 44 patients who were randomized but never received insertion of CVC or exposure to assigned treatment, who were excluded from the evaluable population and were not reviewed by the Evaluation Committee.
Arm/Group Title Omiganan 1% Gel Povidone-Iodine
Hide Arm/Group Description

All treated patients: Properly consented patients who received 1 or more doses of omiganan 1% gel with any post baseline observations (Primary Safety Population).

Modified Intent to Treat Subset: all ITT patients who did not have a BSI at randomization (baseline BSI) as determined by EC adjudication. Patients classified as 'present' (i.e. failure) or 'indeterminate' for baseline BSI were excluded from the MITT population. Patients missing baseline BSI status from EC adjudication were excluded from the MITT population. MITT Among Survivors: patients from the MITT population who did not die on study or who died and were positive (indeterminate or failure)for the study endpoint being analyzed prior to death (as determined by EC adjudication).

All treated patients: Properly consented patients who received 1 or more doses of Povidone-Iodine with any post baseline observations (Primary Safety Population).

Modified Intent to Treat Subset: all ITT patients who did not have a BSI at randomization (baseline BSI) as determined by EC adjudication. Patients classified as 'present' (i.e. failure) or 'indeterminate' for baseline BSI were excluded from the MITT population. Patients missing baseline BSI status from EC adjudication were excluded from the MITT population. MITT Among Survivors: patients from the MITT population who did not die on study or who died and were positive (indeterminate or failure)for the study endpoint being analyzed prior to death (as determined by EC adjudication).

Period Title: Overall Study
Started 907 [1] 908 [2]
Completed 690 720
Not Completed 217 188
[1]
Subjects randomized to omiganan 1% gel who received at least one dose of study treatment.
[2]
Subjects randomized to povidone-iodine who received at least one dose of study treatment.
Arm/Group Title Omiganan 1% Gel Povidone-Iodine Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 907 908 1815
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 907 participants 908 participants 1815 participants
<=18 years
1
   0.1%
7
   0.8%
8
   0.4%
Between 18 and 65 years
488
  53.8%
499
  55.0%
987
  54.4%
>=65 years
418
  46.1%
402
  44.3%
820
  45.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 907 participants 908 participants 1815 participants
60.1  (16.82) 59.4  (17.17) 59.7  (17.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 907 participants 908 participants 1815 participants
Female
350
  38.6%
362
  39.9%
712
  39.2%
Male
557
  61.4%
546
  60.1%
1103
  60.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 907 participants 908 participants 1815 participants
United States 364 366 730
Europe 543 542 1085
1.Primary Outcome
Title Local Catheter Site Infection (LCSI)
Hide Description LCSI was defined as a study catheter showing any 2 of the following criteria: erythema >= 2; edema >= 2; presence of purulence, pain, or abnormal study catheter site warmth. In addition, an action must have been taken that indicated a LCSI was present.
Time Frame study completion
Hide Outcome Measure Data
Hide Analysis Population Description
MITT among Survivors: patients from the MITT population (all ITT patients who did not have a baseline BSI) who did not die on study, or who died and were positive (indeterminate or failure) for LCSI prior to death (as determined by EC adjudication).
Arm/Group Title Omiganan 1% Gel Povidone-Iodine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 793 818
Measure Type: Number
Unit of Measure: Events
50 70
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omiganan 1% Gel, Povidone-Iodine
Comments Adequate power was provided to test the null hypothesis that there would be no difference between treatment groups for LCSI. Overall LCSI rate was assumed to be approx. 7.5%, with reduction of LCSI by 40% with omiganan. LCSI rates in placebo and omiganan groups would be 9.375% and 5.625%. Sample size of 1548 in MITT set would provide 80% power to detect this difference between treatments. Sample size was also increased by 19% to account for deaths, for total of 1850 planned patients.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments The primary null hypothesis was tested using the CMH chi-square test stratified region: North America or Europe. Alpha for this test will be 0.05, tow-tailed. No adjustment for multiplicity was performed.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Net percentage difference
Estimated Value 2.25
Confidence Interval 95%
-0.30 to 4.81
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Microbiologically-confirmed LCSI
Hide Description MCLCSI is a subset of EC-adjudicated LCSI for any catheter where there is (1) growth of a recognized pathogen from a culture or any purulence or exudate from the same insertion site, or (2) a positive culture of the subcutaneous segment of the catheter meeting criteria for significant colonization.
Time Frame study completion
Hide Outcome Measure Data
Hide Analysis Population Description
MITT among Survivors: patients from the MITT population (all ITT patients who did not have a baseline BSI) who did not die on study, or who died and were positive (indeterminate or failure) for MCLCSI prior to death (as determined by EC adjudication).
Arm/Group Title Omiganan 1% Gel Povidone-Iodine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 792 818
Measure Type: Number
Unit of Measure: Events
31 62
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omiganan 1% Gel, Povidone-Iodine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Net percentage difference
Estimated Value 3.67
Confidence Interval 95%
1.40 to 5.93
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Catheter Colonization (CC)
Hide Description CC was defined as a positive culture of any catheter segment >= 15 CFU (roll-plate method) or >999 CFU/ml (sonication method) or a positive blood culture drawn via the catheter where the time-to-positivity difference of catheter line vs. peripheral blood >120 minutes (catheter positive first).
Time Frame study completion
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Among Survivors: patients from the MITT population (all ITT patients who did not have a baseline BSI) who did not die on study, or who died and were positive (indeterminate or failure) for catheter colonization prior to death (as determined EC adjudication).
Arm/Group Title Omiganan 1% Gel Povidone-Iodine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 845 868
Measure Type: Number
Unit of Measure: Events
369 478
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omiganan 1% Gel, Povidone-Iodine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Net percentage difference
Estimated Value 11.40
Confidence Interval 95%
6.70 to 16.11
Estimation Comments [Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Catherine Hardalo, MD Vice President Anti-Infectives, Clinical Development
Organization: Cadence Pharmaceuticals, Inc.
Phone: 858-436-1439
EMail: chardalo@cadencepharm.com
Layout table for additonal information
Responsible Party: Catherine Hardalo, MD. Vice President, Anti Infectives Clinical Development, Cadence Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00231153    
Other Study ID Numbers: CPI-226-03
EudraCT Number: 2005-003194-24
First Submitted: October 3, 2005
First Posted: October 4, 2005
Results First Submitted: June 30, 2009
Results First Posted: August 13, 2009
Last Update Posted: August 13, 2009