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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00595 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| ACCL1034 | Other Identifier | Childrens Oncology Group | |
| COG-ACCL1034 | Other Identifier | DCP | |
| ACCL1034 | Other Identifier | CTEP | |
| R01CA163394 | U.S. NIH Grant/Contract | View source | |
| U10CA095861 | U.S. NIH Grant/Contract | View source | |
| UG1CA189955 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (CHG cleansing wipe) | Experimental | Patients receive CHG cleansing with topical skin wipes QD for 90 days. |
|
| Arm II (control) | Active Comparator | Patients receive control cleansing with topical skin wipes QD for 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine Gluconate Skin Cleanser | Procedure | Given CHG cleansing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Central Line-associated Bloodstream Infections (CLABSI) Events During the At-risk Days | 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. | Up to 90 days post enrollment date |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Multi-drug Resistant Organisms (MDRO) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle M Zerr | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States | ||
| Miller Children's and Women's Hospital Long Beach |
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| Label | URL |
|---|---|
| Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Arm II (Control) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2014 |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Mild Soap Skin Cleanser | Procedure | Given control cleansing |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Up to 90 days post enrollment date |
| Percentage of Patients Who Acquire Cutaneous Bacterial Isolates With Reduced Susceptibility to Chlorhexidine Gluconate (CHG) | 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. | Up to 90 days post enrollment date |
| Rate of Bacteremia Per 1000 At-risk Days | A bacteremia episode is defined any positive blood culture. At risk days are defined as days with eligible central lines in place. | Up to 90 days post enrollment date |
| Long Beach |
| California |
| 90806 |
| United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Valley Children's Hospital | Madera | California | 93636 | United States |
| Children's Hospital and Research Center at Oakland | Oakland | California | 94609-1809 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| UCSF Medical Center-Parnassus | San Francisco | California | 94143 | United States |
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | United States |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | United States |
| Nemours Children's Hospital | Orlando | Florida | 32827 | United States |
| Nemours Children's Clinic - Pensacola | Pensacola | Florida | 32504 | United States |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | 30322 | United States |
| University of Illinois | Chicago | Illinois | 60612 | United States |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | United States |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | United States |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | 11040 | United States |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| The Toledo Hospital/Toledo Children's Hospital | Toledo | Ohio | 43606 | United States |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | United States |
| T C Thompson Children's Hospital | Chattanooga | Tennessee | 37403 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | United States |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Children's Hospital of San Antonio | San Antonio | Texas | 78207 | United States |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | United States |
| Madigan Army Medical Center | Tacoma | Washington | 98431 | United States |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | United States |
| Children's Hospital | London | Ontario | N6A 5W9 | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| The Montreal Children's Hospital of the MUHC | Montreal | Quebec | H3H 1P3 | Canada |
| San Jorge Children's Hospital | San Juan | 00912 | Puerto Rico |
| University Pediatric Hospital | San Juan | 00926 | Puerto Rico |
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 |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Central Line-associated Bloodstream Infections (CLABSI) Events During the At-risk Days | 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. | 3 patients were excluded (2 ineligible and 1 withdrew consent) leaving 174 patients in the analyses. | Posted | Number | 95% Confidence Interval | CLABSI per 1000 at-risk days. | Up to 90 days post enrollment date |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Multi-drug Resistant Organisms (MDRO) | 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. | 3 patients were excluded (2 ineligible and 1 withdrew consent) leaving 174 patients in the analyses. | Posted | Number | Percentage of patients | Up to 90 days post enrollment date |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Acquire Cutaneous Bacterial Isolates With Reduced Susceptibility to Chlorhexidine Gluconate (CHG) | 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. | 135 participants contributed a baseline and at least one follow-up swab and were included in this analysis | Posted | Number | percentage of patients | Up to 90 days post enrollment date |
|
| ||||||||||||||||||||||||||||||
| Secondary | Rate of Bacteremia Per 1000 At-risk Days | A bacteremia episode is defined any positive blood culture. At risk days are defined as days with eligible central lines in place. | 3 patients were excluded (2 ineligible and 1 withdrew consent) leaving 174 patients in the analysis. | Posted | Number | 95% Confidence Interval | bacteremia per 1000 at-risk days | Up to 90 days post enrollment date |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 1 | 88 | 0 | 88 | 22 | 88 |
| EG001 | 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 | 3 | 86 | 2 | 86 | 14 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Multi-organ failure | General disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
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Must obtain prior sponsor approval
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Results Reporting Coordinator | Children's Oncology Group | 626-447-0064 | resultsreportingcoordinator@childrensoncologygroup.org |
| Feb 11, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D009369 | Neoplasms |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Canada |
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| Units | Counts |
|---|---|
| Participants |
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