Antimicrobial Catheter Securement Dressings for the Prevention of Cvc-related Bloodstream Infections in Cancer Patients (COAT)

December 8, 2015 updated by: Maria J.G.T. Vehreschild, University of Cologne

Chlorhexidine Containing Iv-securement Dressings for the Prevention of Central Venous Catheter-related Blood Stream Infections in Neutropenic Patients: a Randomized Trial

In neutropenic cancer patients, catheter-related bloodstream infections may cause severe infections and even death. To assess the prophylactic effect of a chlorhexidine coated catheter securement dressing on the incidence of catheter-related bloodstream infections, this open, randomized trial is being carried out. CHG iv Tegaderm securement dressing will be randomized in a 1:1 fashion against Tegaderm Advanced iv securement dressing.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
630

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Universitätsmedizin Berlin - Charité
    • Bavaria
      • Munich, Bavaria, Germany, 80804
        • Klinikum Schwabing
      • Munich, Bavaria, Germany, 81737
        • Klinikum Neuperlach
    • NRW
      • Aachen, NRW, Germany, 52074
        • Universitätsklinikum Aachen
      • Cologne, NRW, Germany, 50937
        • University Hospital Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients receiving a central venous catheter for chemotherapy of AML or ALL
  • Patients receiving a central venous catheter for high-dose chemotherapy with consecutive autologous stem cell transplantation or any other condition with an expected duration of chemotherapy-associated neutropenia of at least 5 days and an expected duration of central venous catheter use of at least 10 days
  • Age >= 18 years

Exclusion Criteria:

  • Condition with an expected duration of chemotherapy-associated neutropenia of at less than 5 days and an expected duration of central venous catheter use of less than 10 days
  • Use of a central venous catheter with antimicrobial coating other than chlorhexidine and/or silver-sulfadiazine
  • Limited venous status, impeding acquisition of peripheral blood cultures in case of febrile neutropenia
  • Patients previously enrolled in the study
  • Tunneled central venous catheters
  • Shaldon catheters
  • CVC insertion via the V. femoralis
  • Fever (T > 37.8°C) related to a suspected or confirmed bacterial infection at randomization
  • Known allergic/hypersensitivity reaction to any compounds of the treatment
  • Legal incapacity or limited legal capacity
  • Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 3M™ Tegaderm CHG IV
Patients receive the 3M Tegaderm CHG IV securement dressing after placement of a central venous catheter.
Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV
Patients receive the 3M™ Tegaderm CHG IV securement dressing or the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.
Placebo Comparator: 3M™ Tegaderm™ Advanced IV'
Patients receive the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.
Device: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV
Patients receive the 3M™ Tegaderm CHG IV securement dressing or the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter
Time Frame: 14 days
Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter
14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of definite catheter related bloodstream infection-related severe sepsis during the first 14 days after placement of the central venous catheter
Time Frame: 14 days
Incidence of definite catheter related bloodstream infection-related severe sepsis during the first 14 days after placement of the central venous catheter
14 days
Definite catheter-related bloodstream infection-related mortality during the first 14 days after placement of the central venous catheter
Time Frame: 14 days
Definite catheter-related bloodstream infection-related mortality during the first 14 days after placement of the central venous catheter
14 days
Overall incidence of catheter-related bloodstream infection
Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Overall incidence of catheter-related bloodstream infection (evaluated by definite, probable and proven criteria)
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Overall catheter-related bloodstream infection-related severe sepsis
Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Overall catheter-related bloodstream infection-related severe sepsis (evaluated by definite, probable and proven criteria)
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Overall catheter-related bloodstream infection-related mortality
Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Overall catheter-related bloodstream infection-related mortality(evaluated by definite, probable and proven criteria)
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Overall mortality
Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Overall mortality
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Time to removal of central venous catheter
Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Time to removal of central venous catheter
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Time to central venous catheter-related blood stream infections
Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Time to central venous catheter-related blood stream infections
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Time to first neutropenic fever
Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Time to first neutropenic fever
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Rate of unplanned changes
Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Rate of unplanned changes of the catheter securement dressing.
From placement of the central venous catheter until the follow-up at a maximum of 56 days
Tolerability/safety
Time Frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days
Tolerability/safety is defined as the number of toxicity-related study therapy discontinuations.
From placement of the central venous catheter until the follow-up at a maximum of 56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Cologne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
3M

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria JG Vehreschild, Dr. med., University Hospital of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DRKS00003368

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bloodstream Infection

Clinical Trials on 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings