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Completed

NCT Number: NCT01544686

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

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.

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Key information

Conditions

Bloodstream Infection Agranulocytosis Body Temperature Changes Cytopenia Fever Hematologic Diseases Hemic and Lymphatic Diseases Infections Inflammation Leukocyte Disorders Leukopenia Neoplasms Neutropenia Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Neuperlach, Munich, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV

Device

Patients receive the 3M™ Tegaderm CHG IV securement dressing or the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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)

  5. 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)

  6. Overall mortality

    Time frame: From placement of the central venous catheter until the follow-up at a maximum of 56 days

    Overall mortality

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Collaborators

  • 3M

Registry information

Official study title

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

Acronym: COAT

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 6, 2012
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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