InfectionPhase 3NCT00231153
Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters
A Phase 3 study testing Omiganan 1% gel and Povidone-Iodine 10% in people with Infection, run by Cadence Pharmaceuticals at 57 sites in 4 countries.
Trial summary
The purpose of this study is to determine whether treatment with topical omiganan is more effective than treatment with topical povidone-iodine in preventing local catheter site infections and catheter colonization in patients who have central venous catheters. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Omiganan 1% gel and Povidone-Iodine 10%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,859 participants
- Where
- 57 sitesin 4 countries
- Study dates
- Aug 2005to Jul 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
57 sites in 4 countries.
57 sites in 4 countries
United States36 sites
Study site
Arcadia, California
Study site
Bridgeport, Connecticut
Study site
Brooklyn, New York
Study site
Camden, New Jersey
Study site
Denver, Colorado
Study site
El Paso, Texas
Study site
Elk Grove Village, Illinois
Study site
Fort Gordon, Georgia
Study site
Fort Worth, Texas
Study site
Glendale, California
Study site
Hoffman Estates, Illinois
Study site
Houston, Texas
Study site
Jacksonville, Florida
Study site
Jamaica, New York
Study site
Kansas City, Missouri
Study site
Long Beach, California
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
Lubbock, Texas
Study site
Madera, California
Study site
Marietta, Georgia
Study site
Memphis, Tennessee
Study site
Miami, Florida
Study site
Mobile, Alabama
Study site
Morgantown, Virginia
Study site
Newark, New Jersey
Study site
Oklahoma City, Oklahoma
Study site
Opelousas, Louisiana
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Saint Paul, Minnesota
Study site
San Diego, California
Study site
San Francisco, California
Study site
Shreveport, Louisiana
Study site
Syracuse, New York
Study site
Torrance, California
France9 sites
Study site
Bourg-en-Bresse
Study site
Brive-la-Gaillarde
Study site
La Roche-sur-Yon
Study site
Limoges
Study site
Montauban
Study site
Orléans
Study site
Pau
Study site
Poitiers
Study site
Tours
Spain8 sites
Study site
Alcalá de Henares
Study site
Barcelona
Study site
Cadiz
Study site
El Palmar (Murcia)
Study site
Las Palmas de Gran Canaria
Study site
Madrid
Study site
Palma de Mallorca
Study site
Seville
Germany4 sites
Study site
Halle
Study site
Jena
Study site
Leipzig
Study site
Regensburg
About this study
Official 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
The purpose of this study is to determine whether treatment with topical omiganan is more effective than treatment with topical povidone-iodine in preventing local catheter site infections and catheter colonization in patients who have central venous catheters.
Read the detailed description
Study design:
This is a phase 3, multi-center, randomized, Evaluation Committee-blinded study in patients undergoing noncuffed central venous catheterization using either a single lumen or multi-lumen catheter, and for whom the catheter is expected to be in place for at least 48 hours and for no longer than 28 days. Patients will be randomized within 4 hours of the insertion of the first study CVC.
The first study catheter for all patients must be a noncuffed (nontunneled) central venous catheter (CVC). Additionally, only catheters inserted using povidone iodine to prepare the insertion site are eligible to become study catheters. CVCs will be inserted either into the axillary, jugular, subclavian, or femoral vein. Following the first study CVC insertion, additional CVCs, as well as arterial catheters and PICC lines will be allowed as study catheters. Only catheters that have not been impregnated with an antimicrobial substance (e.g. bonded catheters, antimicrobial impregnated, silver tipped, etc) may be used as study catheters. Study catheters must have a skin/catheter interface; for example, introducers will be allowed as study catheters but any catheter, including a CVC, inserted through the introducer will be deemed a non-study catheter. Once a patient has been randomized to either treatment, all study catheters will receive the same treatment.
NIH (NCID) and/or local hospital guidelines will be followed for maximal sterile barrier precautions. The catheter site will be disinfected using 10% povidone iodine for a minimum of 2 minutes per established CDC guidelines prior to catheter insertion. Patients randomized to the omiganan 1% gel group will receive an application of omiganan 1% gel around the catheter insertion site following catheter insertion. Patients randomized to the povidone iodine group will receive no further antisepsis treatment other than cleansing the site with povidone iodine at dressing changes. For patients in both groups, the catheterization site will be covered with a semitransparent dressing provided by the sponsor.
Every 3 days the dressing will be changed. Skin irritation, erythema and edema will be assessed as well as the presence of purulence, moisture, ecchymosis, abnormally warm tissue temperature and/or site pain/tenderness.
Patients will be discharged from the study following the removal of the final study catheter or on study day 28, whichever is sooner. Patients or their legal representatives will be contacted at least 28 days after study discharge/withdrawal for safety follow-up purposes.
- Conditions
- Infection
- Being tested
- Omiganan 1% gel, Povidone-Iodine 10%
- Keywords
- catheter site infection, catheter colonization, catheter related blood stream infection, patients with central venous catheters
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omiganan 1% gelDrug
Patients randomized to omiganan group will receive an application of omiganan gel around the catheter insertion site following catheter insertion. Every 3 days the dressing will be changed and patients will receive a new application of Omiganan 1% gel.
Povidone-Iodine 10%Drug
All CVC sites will be disinfected using a 10% povidone-iodine scrub for a minimum of 2 minutes prior to catheter insertion. Patients randomized to the povidone-iodine group will receive no further antiseptic treatment after catheter insertion until dressing changes. Every three days the dressing will be changed and the catheter site will be sterilized with povidone-iodine.
| Study group | Role | What they receive |
|---|---|---|
| Povidone-Iodine 10% | Active comparator | Not described Receives: Drug: Povidone-Iodine 10% |
| omiganan 1% gel | Experimental | Not described Receives: Drug: Omiganan 1% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Catheter Site Infection (LCSI)
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.
Measured: study completion
Secondary outcomes (2)
Microbiologically-confirmed LCSI
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.
Measured: study completion
Catheter Colonization (CC)
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).
Measured: study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startAug 2005
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,859 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cadence Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231153
- Sponsor's protocol ID
- CPI-226-03
- Other IDs
- EudraCT Number: 2005-003194-24
- Status last verified
- Jun 2009
- First submitted
- 3 Oct 2005
- Last updated
- 13 Aug 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00231153
- Acronym / sponsor ID
- CPI-226-03
- Conditions
- Infection
- Keywords
- catheter site infection, catheter colonization, catheter related blood stream infection, patients with central venous catheters
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,859 participants (actual)
- Lead sponsor
- Cadence PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 4 Oct 2005 (estimated)
- Results
- Posted 13 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether treatment with topical omiganan is more effective than treatment with topical povidone-iodine in preventing local catheter site infections and catheter colonization in patients who have central venous catheters.
Detailed description
Study design:
This is a phase 3, multi-center, randomized, Evaluation Committee-blinded study in patients undergoing noncuffed central venous catheterization using either a single lumen or multi-lumen catheter, and for whom the catheter is expected to be in place for at least 48 hours and for no longer than 28 days. Patients will be randomized within 4 hours of the insertion of the first study CVC.
The first study catheter for all patients must be a noncuffed (nontunneled) central venous catheter (CVC). Additionally, only catheters inserted using povidone iodine to prepare the insertion site are eligible to become study catheters. CVCs will be inserted either into the axillary, jugular, subclavian, or femoral vein. Following the first study CVC insertion, additional CVCs, as well as arterial catheters and PICC lines will be allowed as study catheters. Only catheters that have not been impregnated with an antimicrobial substance (e.g. bonded catheters, antimicrobial impregnated, silver tipped, etc) may be used as study catheters. Study catheters must have a skin/catheter interface; for example, introducers will be allowed as study catheters but any catheter, including a CVC, inserted through the introducer will be deemed a non-study catheter. Once a patient has been randomized to either treatment, all study catheters will receive the same treatment.
NIH (NCID) and/or local hospital guidelines will be followed for maximal sterile barrier precautions. The catheter site will be disinfected using 10% povidone iodine for a minimum of 2 minutes per established CDC guidelines prior to catheter insertion. Patients randomized to the omiganan 1% gel group will receive an application of omiganan 1% gel around the catheter insertion site following catheter insertion. Patients randomized to the povidone iodine group will receive no further antisepsis treatment other than cleansing the site with povidone iodine at dressing changes. For patients in both groups, the catheterization site will be covered with a semitransparent dressing provided by the sponsor.
Every 3 days the dressing will be changed. Skin irritation, erythema and edema will be assessed as well as the presence of purulence, moisture, ecchymosis, abnormally warm tissue temperature and/or site pain/tenderness.
Patients will be discharged from the study following the removal of the final study catheter or on study day 28, whichever is sooner. Patients or their legal representatives will be contacted at least 28 days after study discharge/withdrawal for safety follow-up purposes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Povidone-Iodine 10% | Active comparator | Drug: Povidone-Iodine 10% |
| omiganan 1% gel | Experimental | Drug: Omiganan 1% gel |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omiganan 1% gelPatients randomized to omiganan group will receive an application of omiganan gel around the catheter insertion site following catheter insertion. Every 3 days the dressing will be changed and patients will receive a new application of Omiganan 1% gel. | Drug | omiganan 1% gel |
| Povidone-Iodine 10%All CVC sites will be disinfected using a 10% povidone-iodine scrub for a minimum of 2 minutes prior to catheter insertion. Patients randomized to the povidone-iodine group will receive no further antiseptic treatment after catheter insertion until dressing changes. Every three days the dressing will be changed and the catheter site will be sterilized with povidone-iodine. | Drug | Povidone-Iodine 10% |
Primary outcome
Local Catheter Site Infection (LCSI)
Time frame: study completion
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.
2 secondary outcomes
Microbiologically-confirmed LCSI
Time frame: study completion
Catheter Colonization (CC)
Time frame: study completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
57 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omiganan 1% gel and Povidone-Iodine 10% in people with Infection, run by Cadence Pharmaceuticals at 57 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, France, Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Catheter Site Infection (LCSI) (time frame: study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2009.