NCT01544686

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

3.7 years

First QC Date

February 22, 2012

Last Update Submit

December 8, 2015

Conditions

Bloodstream Infection

Keywords

neutropeniacancerfevercentral venous catheterinfection

Outcome Measures

Primary Outcomes (1)

  • Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter

    Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter

    14 days

Secondary Outcomes (11)

  • 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

    14 days

  • Overall incidence of catheter-related bloodstream infection

    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

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

  • Overall catheter-related bloodstream infection-related mortality

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

  • +6 more secondary outcomes

Study Arms (2)

3M™ Tegaderm CHG IV

ACTIVE COMPARATOR

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

3M™ Tegaderm™ Advanced IV'

PLACEBO COMPARATOR

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

Interventions

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

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

3M™ Tegaderm CHG IV3M™ Tegaderm™ Advanced IV'

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Klinikum Schwabing

Munich, Bavaria, 80804, Germany

Location

Klinikum Neuperlach

Munich, Bavaria, 81737, Germany

Location

Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitätsmedizin Berlin - Charité

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (3)

  • Schalk E, Teschner D, Hentrich M, Boll B, Panse J, Schmidt-Hieber M, Vehreschild MJGT, Biehl LM. Central venous catheter-related bloodstream infections in patients with hematological malignancies: Comparison of data from a clinical registry and a randomized controlled trial. Infect Control Hosp Epidemiol. 2020 Feb;41(2):254-256. doi: 10.1017/ice.2019.335. No abstract available.

    PMID: 31818338DERIVED

  • Schalk E, Biehl LM, Farber J, Schluter D, Vehreschild MJGT, Fischer T. Determination of a Cutoff Time Point for Prophylactic Exchange of Central Venous Catheters for Prevention of Central Venous Catheter-Related Bloodstream Infections in Patients with Hematological Malignancies. Infect Control Hosp Epidemiol. 2017 Jul;38(7):888-889. doi: 10.1017/ice.2017.92. Epub 2017 May 18. No abstract available.

    PMID: 28514979DERIVED

  • Biehl LM, Huth A, Panse J, Kramer C, Hentrich M, Engelhardt M, Schafer-Eckart K, Kofla G, Kiehl M, Wendtner CM, Karthaus M, Ullmann AJ, Hellmich M, Christ H, Vehreschild MJ. A randomized trial on chlorhexidine dressings for the prevention of catheter-related bloodstream infections in neutropenic patients. Ann Oncol. 2016 Oct;27(10):1916-22. doi: 10.1093/annonc/mdw275. Epub 2016 Jul 25.

    PMID: 27456299DERIVED

MeSH Terms

Conditions

SepsisNeutropeniaNeoplasmsFeverInfections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersBody Temperature ChangesSigns and Symptoms

Study Officials

  • Maria JG Vehreschild, Dr. med.

    University Hospital of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2012

First Posted

March 6, 2012

Study Start

February 1, 2012

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations

DE(5)