Trial Outcomes & Findings for 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 (NCT NCT01817075)

Last Updated: 2021-06-22

Results Overview

Rate of CLABSI per 1000 at-risk days. CLABSI outcome is defined according to the January 2015 Centers for Disease Control and Prevention (CDC) criteria. At risk days are defined as days with eligible central lines in place.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

177 participants

Primary outcome timeframe

Up to 90 days post enrollment date

Results posted on

2021-06-22

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (CHG Cleansing Wipe) Patients receive CHG cleansing with topical skin wipes QD for 90 days. Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Arm II (Control) Patients receive control cleansing with topical skin wipes QD for 90 days. Laboratory Biomarker Analysis: Correlative studies Mild Soap Skin Cleanser: Given control cleansing Questionnaire Administration: Ancillary studies
Overall Study STARTED	88	89
Overall Study COMPLETED	41	54
Overall Study NOT COMPLETED	47	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (CHG Cleansing Wipe) Patients receive CHG cleansing with topical skin wipes QD for 90 days. Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Arm II (Control) Patients receive control cleansing with topical skin wipes QD for 90 days. Laboratory Biomarker Analysis: Correlative studies Mild Soap Skin Cleanser: Given control cleansing Questionnaire Administration: Ancillary studies
Overall Study Adverse Event	7	5
Overall Study Physician Decision	9	12
Overall Study Withdrawal by Subject	31	15
Overall Study Received Sorafenib after enrollment	0	1
Overall Study Ineligible	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (CHG Cleansing Wipe) n=88 Participants Patients receive CHG cleansing with topical skin wipes QD for 90 days. Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Arm II (Control) n=89 Participants Patients receive control cleansing with topical skin wipes QD for 90 days. Laboratory Biomarker Analysis: Correlative studies Mild Soap Skin Cleanser: Given control cleansing Questionnaire Administration: Ancillary studies	Total n=177 Participants Total of all reporting groups
Age, Categorical <=18 years	83 Participants n=5 Participants	88 Participants n=7 Participants	171 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	7.4 years STANDARD_DEVIATION 5.8 • n=5 Participants	5 years STANDARD_DEVIATION 4.8 • n=7 Participants	6.2 years STANDARD_DEVIATION 5.4 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	36 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	69 Participants n=5 Participants	63 Participants n=7 Participants	132 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) White	51 Participants n=5 Participants	54 Participants n=7 Participants	105 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	21 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment United States	77 participants n=5 Participants	82 participants n=7 Participants	159 participants n=5 Participants
Region of Enrollment Canada	11 participants n=5 Participants	7 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 90 days post enrollment date

Population: 3 patients were excluded (2 ineligible and 1 withdrew consent) leaving 174 patients in the analyses.

Outcome measures

Outcome measures
Measure	Arm I (CHG Cleansing Wipe) n=88 Participants Patients receive CHG cleansing with topical skin wipes QD for 90 days. Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Arm II (Control) n=86 Participants Patients receive control cleansing with topical skin wipes QD for 90 days. Laboratory Biomarker Analysis: Correlative studies Mild Soap Skin Cleanser: Given control cleansing Questionnaire Administration: Ancillary studies
Central Line-associated Bloodstream Infections (CLABSI) Events During the At-risk Days	5.44 CLABSI per 1000 at-risk days. Interval 3.62 to 8.18	3.1 CLABSI per 1000 at-risk days. Interval 1.82 to 5.28

SECONDARY outcome

Timeframe: Up to 90 days post enrollment date

Population: 3 patients were excluded (2 ineligible and 1 withdrew consent) leaving 174 patients in the analyses.

MDROs are defined as Staphylococcus aureus resistant to oxacillin, Enterococcus spp. resistant to vancomycin, Klebsiella pneumoniae or Escherichia coli non-susceptible (intermediate or resistant) to ceftriaxone, ceftazidime, cefepime or any carbapenem, and Pseudomonas aeruginosa or Acinetobacter baumannii resistant to any carbapenem or ceftazidime, and either an aminoglycoside or fluoroquinolone. Clostridium difficile infection (CDI) is included as an MDRO and is defined as a positive lab test for C. difficile and \> 3 unformed stools in \< 24 hours.

Outcome measures

Outcome measures
Measure	Arm I (CHG Cleansing Wipe) n=88 Participants Patients receive CHG cleansing with topical skin wipes QD for 90 days. Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Arm II (Control) n=86 Participants Patients receive control cleansing with topical skin wipes QD for 90 days. Laboratory Biomarker Analysis: Correlative studies Mild Soap Skin Cleanser: Given control cleansing Questionnaire Administration: Ancillary studies
Percentage of Patients With Multi-drug Resistant Organisms (MDRO)	15 Percentage of patients	12 Percentage of patients

SECONDARY outcome

Timeframe: Up to 90 days post enrollment date

Population: 135 participants contributed a baseline and at least one follow-up swab and were included in this analysis

Susceptibility to CHG is defined by MIC cutoff that is cutaneous staphylococcal isolate isolated from a follow-up swab with CHG MIC \> 4 ug/mL in patient without a resistant staphylococcal isolate isolated from a baseline swab.

Outcome measures

Outcome measures
Measure	Arm I (CHG Cleansing Wipe) n=62 Participants Patients receive CHG cleansing with topical skin wipes QD for 90 days. Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Arm II (Control) n=73 Participants Patients receive control cleansing with topical skin wipes QD for 90 days. Laboratory Biomarker Analysis: Correlative studies Mild Soap Skin Cleanser: Given control cleansing Questionnaire Administration: Ancillary studies
Percentage of Patients Who Acquire Cutaneous Bacterial Isolates With Reduced Susceptibility to Chlorhexidine Gluconate (CHG)	17.7 percentage of patients	5.5 percentage of patients

SECONDARY outcome

Timeframe: Up to 90 days post enrollment date

Population: 3 patients were excluded (2 ineligible and 1 withdrew consent) leaving 174 patients in the analysis.

A bacteremia episode is defined any positive blood culture. At risk days are defined as days with eligible central lines in place.

Outcome measures

Outcome measures
Measure	Arm I (CHG Cleansing Wipe) n=88 Participants Patients receive CHG cleansing with topical skin wipes QD for 90 days. Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Arm II (Control) n=86 Participants Patients receive control cleansing with topical skin wipes QD for 90 days. Laboratory Biomarker Analysis: Correlative studies Mild Soap Skin Cleanser: Given control cleansing Questionnaire Administration: Ancillary studies
Rate of Bacteremia Per 1000 At-risk Days	7.24 bacteremia per 1000 at-risk days Interval 5.5 to 9.5	4.93 bacteremia per 1000 at-risk days Interval 3.5 to 6.9

Adverse Events

Arm I (CHG Cleansing Wipe)

Serious events: 0 serious events

Other events: 22 other events

Deaths: 1 deaths

Arm II (Control)

Serious events: 2 serious events

Other events: 14 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (CHG Cleansing Wipe) n=88 participants at risk Patients receive CHG cleansing with topical skin wipes QD for 90 days. Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Arm II (Control) n=86 participants at risk Patients receive control cleansing with topical skin wipes QD for 90 days. Laboratory Biomarker Analysis: Correlative studies Mild Soap Skin Cleanser: Given control cleansing Questionnaire Administration: Ancillary studies
Cardiac disorders Cardiac arrest	0.00% 0/88 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	1.2% 1/86 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
General disorders Multi-organ failure	0.00% 0/88 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	1.2% 1/86 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Other adverse events

Other adverse events
Measure	Arm I (CHG Cleansing Wipe) n=88 participants at risk Patients receive CHG cleansing with topical skin wipes QD for 90 days. Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Arm II (Control) n=86 participants at risk Patients receive control cleansing with topical skin wipes QD for 90 days. Laboratory Biomarker Analysis: Correlative studies Mild Soap Skin Cleanser: Given control cleansing Questionnaire Administration: Ancillary studies
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/88 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	1.2% 1/86 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Mucositis oral	1.1% 1/88 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/86 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Skin and subcutaneous tissue disorders Rash maculo-papular	12.5% 11/88 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	8.1% 7/86 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Sepsis	1.1% 1/88 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/86 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	10.2% 9/88 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	4.7% 4/86 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Skin and subcutaneous tissue disorders Skin ulceration	1.1% 1/88 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/86 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Skin and subcutaneous tissue disorders Urticaria	1.1% 1/88 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	3.5% 3/86 • Collected Adverse Events within the 90 day observation period Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Must obtain prior sponsor approval
Publication restrictions are in place

Restriction type: OTHER