NCT01817075

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

Completed Phase 3 Results posted Last updated 22 June 2021

What this trial tests

Phase 3 trial testing Chlorhexidine Gluconate Skin Cleanser in Bacterial Infection in 177 participants. Completed in 31 March 2020.

Timeline

4 November 2013

Primary endpoint
31 March 2019

31 March 2020

Quick facts

Lead sponsor	Children's Oncology Group
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	177
Start date	4 November 2013
Primary completion	31 March 2019
Estimated completion	31 March 2020
Sites	59 locations across Canada, United States, Puerto Rico

Drugs / interventions tested

• Chlorhexidine Gluconate Skin Cleanser
• Laboratory Biomarker Analysis — full drug profile →
• Mild Soap Skin Cleanser
• Questionnaire Administration

Conditions studied

• Bacterial Infection — all drugs for Bacterial Infection →
• Benign Neoplasm — all drugs for Benign Neoplasm →
• Malignant Neoplasm — all drugs for Malignant Neoplasm →
• Methicillin-Resistant Staphylococcus Aureus Infection — all drugs for Methicillin-Resistant Staphylococcus Aureus Infection →

Sponsor

Children's Oncology Group — full company profile →

Who can join

Adults 2 Months to 21, any sex, with Bacterial Infection or Benign Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Central Line-associated Bloodstream Infections (CLABSI) Events During the At-risk Days Primary · Up to 90 days post enrollment date

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.

Group	Value	95% CI
Arm I (CHG Cleansing Wipe)	5.44	3.62 – 8.18
Arm II (Control)	3.1	1.82 – 5.28

Percentage of Patients With Multi-drug Resistant Organisms (MDRO) Secondary · Up to 90 days post enrollment date

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.

Group	Value	95% CI
Arm I (CHG Cleansing Wipe)	15
Arm II (Control)	12

Percentage of Patients Who Acquire Cutaneous Bacterial Isolates With Reduced Susceptibility to Chlorhexidine Gluconate (CHG) Secondary · Up to 90 days post enrollment date

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.

Group	Value	95% CI
Arm I (CHG Cleansing Wipe)	17.7
Arm II (Control)	5.5

Rate of Bacteremia Per 1000 At-risk Days Secondary · Up to 90 days post enrollment date

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

Group	Value	95% CI
Arm I (CHG Cleansing Wipe)	7.24	5.5 – 9.5
Arm II (Control)	4.93	3.5 – 6.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Collected Adverse Events within the 90 day observation period. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm I (CHG Cleansing Wipe)

Serious: 0/88 (0%)

Deaths: 1/88

Arm II (Control)

Serious: 2/86 (2%)

Deaths: 3/86

Serious adverse events (2 terms)

Reaction	System	Arm I (CHG Cleansing Wipe)	Arm II (Control)
Cardiac arrest	Cardiac disorders	—	—
Multi-organ failure	General disorders	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Arm I (CHG Cleansing Wipe)	Arm II (Control)
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—
Skin and subcutaneous tissue disorders - Other, specify	Skin and subcutaneous tissue disorders	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—
Hypercalcemia	Metabolism and nutrition disorders	—	—
Mucositis oral	Gastrointestinal disorders	—	—
Sepsis	Infections and infestations	—	—
Skin ulceration	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Cardiac arrest, Multi-organ failure.

Data from ClinicalTrials.gov NCT01817075 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Novel, Widespread <i>qacA</i> Allele Results in Reduced Chlorhexidine Susceptibility in <i>Staphylococcus epidermidis</i>.
   Addetia A, Greninger AL, Adler A, Yuan S, et al · · 2019 · cited 17× · PMID 30988144 · DOI 10.1128/aac.02607-18