Trial Outcomes & Findings for Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters (NCT NCT00231153)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1859 participants

Primary outcome timeframe

study completion

Results posted on

2009-08-13

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Omiganan 1% Gel 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).	Povidone-Iodine 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).
Overall Study STARTED	907	908
Overall Study COMPLETED	690	720
Overall Study NOT COMPLETED	217	188

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omiganan 1% Gel n=907 Participants	Povidone-Iodine n=908 Participants	Total n=1815 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=93 Participants	7 Participants n=4 Participants	8 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	488 Participants n=93 Participants	499 Participants n=4 Participants	987 Participants n=27 Participants
Age, Categorical >=65 years	418 Participants n=93 Participants	402 Participants n=4 Participants	820 Participants n=27 Participants
Age Continuous	60.1 years STANDARD_DEVIATION 16.82 • n=93 Participants	59.4 years STANDARD_DEVIATION 17.17 • n=4 Participants	59.7 years STANDARD_DEVIATION 17.00 • n=27 Participants
Sex: Female, Male Female	350 Participants n=93 Participants	362 Participants n=4 Participants	712 Participants n=27 Participants
Sex: Female, Male Male	557 Participants n=93 Participants	546 Participants n=4 Participants	1103 Participants n=27 Participants
Region of Enrollment United States	364 participants n=93 Participants	366 participants n=4 Participants	730 participants n=27 Participants
Region of Enrollment Europe	543 participants n=93 Participants	542 participants n=4 Participants	1085 participants n=27 Participants

PRIMARY outcome

Timeframe: study completion

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Omiganan 1% Gel n=793 Participants	Povidone-Iodine n=818 Participants
Local Catheter Site Infection (LCSI)	50 Events	70 Events

SECONDARY outcome

Timeframe: study completion

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Omiganan 1% Gel n=792 Participants	Povidone-Iodine n=818 Participants
Microbiologically-confirmed LCSI	31 Events	62 Events

SECONDARY outcome

Timeframe: study completion

Population: 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).

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).

Outcome measures

Outcome measures
Measure	Omiganan 1% Gel n=845 Participants	Povidone-Iodine n=868 Participants
Catheter Colonization (CC)	369 Events	478 Events

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Catherine Hardalo, MD Vice President Anti-Infectives, Clinical Development

Cadence Pharmaceuticals, Inc.

Phone: 858-436-1439

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60