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Impact of Cleansing With Chlorhexidine Gluconate (CHG) on Reducing Central Line Associated Bloodstream Infection (CLABSI) and Acquisition of Multi-Drug Resistant Organisms (MDRO) in Children With Cancer or Those Receiving Allogeneic Hematopoietic Cell Transplantation (HCT)


Phase 3
2 Months
21 Years
Not Enrolling
Both
Bacterial Infection, Infection, Neoplasm, Methicillin-resistant Staphylococcus Aureus Infection

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Trial Information

Impact of Cleansing With Chlorhexidine Gluconate (CHG) on Reducing Central Line Associated Bloodstream Infection (CLABSI) and Acquisition of Multi-Drug Resistant Organisms (MDRO) in Children With Cancer or Those Receiving Allogeneic Hematopoietic Cell Transplantation (HCT)


PRIMARY OBJECTIVES: I. To determine whether chlorhexidine gluconate (CHG) cleansing
decreases central line associated bloodstream infection (CLABSI) in children with cancer or
those receiving an allogeneic hematopoietic cell transplantation (HCT). SECONDARY
OBJECTIVES: I. To determine whether CHG cleansing decreases acquisition of multi-drug
resistant organisms [MDRO: vancomycin resistant enterococci (VRE), methicillin resistant
Staphylococcus aureus (MRSA), etc.] in children with cancer or those receiving allogeneic
HCT. II. To determine whether CHG cleansing in children with cancer or those receiving
allogeneic HCT is associated with cutaneous bacterial isolates with reduced susceptibility
to CHG. III. To determine whether CHG cleansing decreases positive blood cultures in
children with cancer or those receiving allogeneic HCT. OUTLINE: Patients are randomized to
1 of 2 arms. ARM I: Patients receive CHG cleansing with topical skin wipes once daily (QD)
for 90 days. ARM II: Patients receive control cleansing with topical skin wipes QD for 90
days.


Inclusion Criteria:



- All patients undergoing planned allogeneic transplant (both malignant and
non-malignant diagnoses)

- Patients with an oncology diagnosis that are on a chemotherapy regimen that will last
for an additional >= 3 months; patients with an oncology diagnosis that will be on a
chemotherapy regimen for >= 3 months

- Patients must have, or be scheduled to have, an external tunneled central venous
catheter (CVC) (Broviacs, Hickmans, tunneled percutaneously inserted central catheter
(PICCs), etc.) that is expected to remain in place for an additional >= 3 months

Exclusion Criteria:

- Patients with a previous or current line infection are ineligible until 14 days after
the completion of antibiotics

- Subjects who would enroll in the Oncology Patient stratum who are planned to start
conditioning for HCT within 3 months of enrollment are ineligible

- Patients with only non-tunneled CVCs (non-tunneled peripherally inserted central
catheters [PICCs], temporary CVCs, midline catheters, etc) are ineligible

- Patients with only totally implanted CVCs or ports are ineligible

- Patients with a known allergy or hypersensitivity to CHG are ineligible

- Patients with chronic, severe, generalized skin breakdown (such as generalized
blistering, burns, severe graft versus host disease [GVHD] with open sores, etc.) are
ineligible

- Patients enrolled on ACCL0934 are ineligible

- Patients scheduled to receive broad-spectrum prophylactic antibacterial therapy are
ineligible

- Patients receiving sorafenib at the time of enrollment or as part of a treatment plan
scheduled to receive sorafenib are ineligible

- Patients using prophylactic antimicrobial locks in the CVC at the time of enrollment
or as part of a treatment plan scheduled to receive prophylactic antimicrobial locks
in the CVC are ineligible

- Patients previously enrolled on this trial are ineligible

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Number of CLABSI events during the at-risk days

Outcome Description:

Estimated and compared between the 2 arms by a Poisson regression model adjusting for the randomization stratification factor on treatment/diagnosis.

Outcome Time Frame:

Up to 90 days

Safety Issue:

No

Principal Investigator

Danielle Zerr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

ACCL1034

NCT ID:

NCT01817075

Start Date:

June 2013

Completion Date:

Related Keywords:

  • Bacterial Infection
  • Infection
  • Neoplasm
  • Methicillin-resistant Staphylococcus Aureus Infection
  • Bacterial Infections
  • Neoplasms
  • Staphylococcal Infections

Name

Location

Children's Oncology GroupArcadia, California  91006-3776