Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters
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| ClinicalTrials.gov Identifier: NCT00231153 |
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Recruitment Status :
Completed
First Posted : October 4, 2005
Results First Posted : August 13, 2009
Last Update Posted : August 13, 2009
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| 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 |
|---|---|---|
 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 |
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[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.
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| Arm/Group Title | Omiganan 1% Gel | Povidone-Iodine | Total | |
|---|---|---|---|---|
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Arm/Group Description |
[Not Specified] | [Not Specified] | Total of all reporting groups | |
| Overall Number of Baseline Participants | 907 | 908 | 1815 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 907 participants | 908 participants | 1815 participants | |
| <=18 years |
1 0.1%
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7 0.8%
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8 0.4%
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| Between 18 and 65 years |
488 53.8%
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499 55.0%
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987 54.4%
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| >=65 years |
418 46.1%
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402 44.3%
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820 45.2%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 907 participants | 908 participants | 1815 participants | |
| 60.1 (16.82) | 59.4 (17.17) | 59.7 (17.00) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 907 participants | 908 participants | 1815 participants | |
| Female |
350 38.6%
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362 39.9%
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712 39.2%
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| Male |
557 61.4%
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546 60.1%
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1103 60.8%
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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 | |
| Name/Title: | Catherine Hardalo, MD Vice President Anti-Infectives, Clinical Development |
| Organization: | Cadence Pharmaceuticals, Inc. |
| Phone: | 858-436-1439 |
| EMail: | chardalo@cadencepharm.com |
| 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 |