Phase 3
N=177
Chlorhexidine Gluconate Cleansing in Preventing Central Line Associated Bloodstream Infection and Acquisition of Multi-drug Resistant Organisms in Younger Patients With Cancer or Undergoing Donor Stem Cell Transplant
Bacterial Infection · Benign Neoplasm · Malignant Neoplasm · Methicillin-Resistant Staphylococcus Aureus Infection · Myeloid Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT01817075 ↗Enrolled (actual)
177
Serious AEs
1.2%
Results posted
Apr 2020
Primary outcome: Primary: Central Line-associated Bloodstream Infections (CLABSI) Events During the At-risk Days — 5.44; 3.1 CLABSI per 1000 at-risk days.
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Chlorhexidine Gluconate Skin Cleanser (Procedure); Laboratory Biomarker Analysis (Other); Mild Soap Skin Cleanser (Procedure); Questionnaire Administration (Other)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Central Line-associated Bloodstream Infections (CLABSI) Events During the At-risk Days |
5.44; 3.1 | — |
| SECONDARY Percentage of Patients With Multi-drug Resistant Organisms (MDRO) |
15; 12 | — |
| SECONDARY Percentage of Patients Who Acquire Cutaneous Bacterial Isolates With Reduced Susceptibility to Chlorhexidine Gluconate (CHG) |
17.7; 5.5 | — |
| SECONDARY Rate of Bacteremia Per 1000 At-risk Days |
7.24; 4.93 | — |
Summary
This randomized phase III trial studies chlorhexidine gluconate cleansing to see how well it works compared to control cleansing in preventing central line associated bloodstream infection and acquisition of multi-drug resistant organisms in younger patients with cancer or undergoing donor stem cell transplant. Chlorhexidine gluconate may help reduce bloodstream infections and bacterial infections associated with the central line.
Eligibility Criteria
Inclusion Criteria
- TRANSPLANT PATIENTS: all patients undergoing planned allogeneic transplant (both malignant and non-malignant diagnoses)
- ONCOLOGY PATIENTS: patients with an oncology diagnosis that are or will be on a chemotherapy regimen that will last for an additional >= 3 months or are on or will be on a chemotherapy regimen for = 3 months
- Patients with acute myelogenous leukemia (AML) or relapsed acute lymphoblastic leukemia (ALL) that will receive chemotherapy with/without transplant must have, or be scheduled to have, an external tunneled CVC (Broviacs, Hickmans, tunneled PICCs, etc.) and/or non-tunneled PICC that is expected to remain in place for an additional >= 3 months
- All other oncology patients that will receive chemotherapy with/without transplant must have, or be scheduled to have, an external tunneled CVC (Broviacs, Hickmans, tunneled PICCs, etc.) that is expected to remain in place for an additional >= 3 months
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria
- Patients with a previous or current line infection are ineligible until 14 days after the completion of antibiotics
- 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 currently enrolled on Children's Oncology Group (COG) study ACCL0934 are not eligible until they have completed the infection observation period of that study
- Patients scheduled to receive broad-spectrum prophylactic antibacterial therapy are ineligible; patients only receiving prophylaxis for Pneumocystis pneumonia (PCP) (trimethoprim [TMP]/sulfamethoxazole [SMX]) or encapsulated organisms (penicillin) are eligible
- Patients receiving sorafenib at the time of enrollment and those who are scheduled to receive sorafenib as part of a treatment plan are ineligible
- Patients using prophylactic antimicrobial locks in the CVC at the time of enrollment and those who are scheduled to receive antimicrobial locks in the CVC as part of a treatment plan are ineligible
- Patients previously enrolled on this trial are ineligible
- Females who are pregnant or breastfeeding are ineligible
Data sourced from ClinicalTrials.gov (NCT01817075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.