NCT03030989

Brief Summary

This study evaluates the use of 2% CHG washcloths in an outpatient setting for adults after hematopoietic stem cell transplant in prevention of central line associated blood stream infections. Half of the participants will use 2% CHG washcloths and other half will use placebo washcloths.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 10, 2020

Completed
Last Updated

December 10, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

January 23, 2017

Results QC Date

September 30, 2020

Last Update Submit

November 16, 2020

Conditions

Stem Cell Transplant Complications

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Primary Blood Stream Infections

    Blood stream infections are defined by the presence of bacteria in the blood

    14 weeks

  • Number of Participants With Clinical (Culture-negative) Sepsis

    Clinical (culture-negative) sepsis is defined by the presence of low blood pressure without bacteria in the blood

    14 weeks

Study Arms (2)

Chlorhexidine Gluconate 2% Wipe

ACTIVE COMPARATOR
Drug: Chlorhexidine Gluconate 2% Wipe

Placebo wipe

PLACEBO COMPARATOR
Drug: Placebo Wipe

Interventions

Chlorhexidine Gluconate 2% WipeDRUG
Chlorhexidine Gluconate 2% Wipe
Placebo WipeDRUG
Placebo wipe

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted to the University of Chicago Hematopoietic Stem Cell Transplant Unit for transplant
  • Age 18 and up

You may not qualify if:

  • Experienced an allergy or rash related to use of chlorhexidine washcloths or other chlorhexidine products
  • Extensive open wounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

chlorhexidine gluconate

Results Point of Contact

Title
Randee Estes, Study Coordinator
Organization
University of Chicago
restes@medicine.bsd.uchicago.edu
773-702-1209

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2017

First Posted

January 25, 2017

Study Start

January 1, 2017

Primary Completion

January 2, 2019

Study Completion

June 1, 2019

Last Updated

December 10, 2020

Results First Posted

December 10, 2020

Record last verified: 2020-11

Locations

US(1)