Development and Evaluation of a ChlorHexidine Gluconate bAthing pRotocol for Healthcare Settings in Low- and Middle-income Countries (CHARM)

June 30, 2025 updated by: Ebbing Lautenbach, University of Pennsylvania
The overall goal of the ChlorHexidine gluconate (CHG) bAthing pRotocol for healthcare settings in low- and Middle-income countries (CHARM) study is to explore the safety, efficacy and feasibility of utilizing a locally prepared CHG solution and bathing protocol among hospitalized neonates to reduce bacterial colonization and healthcare-associated infection (HAI) burden in hospitalized patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Neonatal sepsis is the third most common cause of neonatal deaths and multidrug-resistant Gram-negative bacteria are now the leading cause of sepsis among hospitalized neonates in south Asia and sub-Saharan Africa, including Botswana. Multidrug-Resistant Organism (MDRO) colonization is thought to precede infection, meaning that pathogens usually are transferred to the skin or intestinal mucosa where they live prior to translocating to the bloodstream or other sterile body compartments, triggering an inflammatory response recognized as clinical sepsis. Colonization is established through direct or indirect contact between a patient and a reservoir that harbors the pathogen.

Multidisciplinary infection prevention and control (IPC) practices can reduce the risk of neonatal MDRO colonization, but once colonized, newborns run the risk of acquiring a serious infection with a difficult-to-treat organism. The use of ancillary IPC measures, including chlorhexidine gluconate (CHG) bathing, has been studied as a de-colonization measure among hospitalized patients. CHG bathing is widely used in Intensive Care Units (ICUs) across high-income countries to reduce bacterial colonization with pathogens, and is being used more frequently in Neonatal Units (NNUs) in low and middle-income countries (LMICs) as a sepsis prevention measure.

The investigators of the CHARM study have developed a protocol to accomplish the following goals:

  1. develop a low-cost, standardized protocol for CHG bathing in the ICU and NNU
  2. assess safety of local CHG preparation among hospitalized neonates
  3. determine the efficacy of CHG bathing using the developed protocol to reduce bacterial colonization and healthcare-associated infection (HAI) burden in hospitalized patients
  4. to assess the feasibility and acceptability of CHG bathing among staff and caregivers

The investigators will utilize a mixed methods study involving both a prospective interventional cohort study following approximately 240 neonates, and qualitative interviews of 10 caregivers and 20 healthcare workers in the NNU and ICU.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Botswana
      • Gaborone, Botswana
        • Princess Marina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Neonates 1-6 days old admitted to the neo-natal unit expected to stay at least 7 days

Exclusion Criteria:

  • Patients with a current weight of <1kg
  • Patients with a current corrected gestational age of <28 weeks (by Ballard score, or by dates if Ballard is not done)
  • Patients with a current diagnosis of hypothermia
  • Patients with a current diagnosis of skin rash or skin injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ≥34 Week Neonates & ≥1.4 kg

Phase 1 of a step-wise enrollment strategy in which chlorhexidine gluconate (CHG) bathing will be administered as follows:

  1. 1% CHG administered twice (2) a week (N=10)
  2. 1% CHG administered five times (5) a week (N=10)
  3. 2% CHG administered twice (2) a week (N=10)
  4. 2% CHG administered five times (5) a week (N=10)
Drug: Chlorhexidine Gluconate (CHG)
A locally-prepared CHG formulation as a 1% or 2% solution
Other Names:
  • Aqueous CHG
Experimental: ≥32 Week Neonates &/or 1.2 kg - 1.4 kg

Phase 2 of a step-wise enrollment strategy in which chlorhexidine gluconate (CHG) bathing will be administered as follows:

  1. 1% CHG administered twice (2) a week (N=20)
  2. 1% CHG administered five times (5) a week (N=20)
  3. 2% CHG administered twice (2) a week (N=20)
  4. 2% CHG administered five times (5) a week (N=20)
Drug: Chlorhexidine Gluconate (CHG)
A locally-prepared CHG formulation as a 1% or 2% solution
Other Names:
  • Aqueous CHG
Experimental: ≥28 Week Neonates &/or 1.0 kg - 1.2 kg

Phase 3 of a step-wise enrollment strategy in which chlorhexidine gluconate (CHG) bathing will be administered as follows:

  1. 1% CHG administered twice (2) a week (N=30)
  2. 1% CHG administered five times (5) a week (N=30)
  3. 2% CHG administered twice (2) a week (N=30)
  4. 2% CHG administered five times (5) a week (N=20)
Drug: Chlorhexidine Gluconate (CHG)
A locally-prepared CHG formulation as a 1% or 2% solution
Other Names:
  • Aqueous CHG
No Intervention: Feasibility Assessment
Semi-structured, qualitative Interviews will be performed with caregivers (N=10) of neonates enrolled in the interventional arms and with healthcare workers (N=20) who care for these neonates in the neonatal unit (NNU) and intensive care unit (ICU).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of locally prepared 1% and 2% chlorhexidine gluconate (CHG) cleansing: Skin integrity
Time Frame: At baseline and 30 minutes post application of CHG solution

Skin condition score: Assessing skin reactions in neonates by a trained study nurse using the Darmstadt scale. The skin of the neonate will be assessed using a scale of 1 to 9, with 1 being the best condition and 9 being the worst condition, based on the following variables: skin breakdown, skin dryness, and erythema.

Stopping rule: Skin fissuring (skin score of >3)
At baseline and 30 minutes post application of CHG solution
Safety of locally prepared 1% and 2% CHG cleansing: Systemic responses
Time Frame: At baseline and 30 minutes post application of CHG solution

Temperature assessments will be performed at baseline and 30 min after application. If hypothermia is detected (defined as temperature below 36.5 C when measured from the same site at 30 minutes), the baby will be bundled and temperature retaken after 30 additional minutes. Babies will also be observed for 30 min for signs of anaphylaxis. Respiratory distress, cyanosis, urticaria, edema, vomiting/diarrhea, or lethargy will elicit a full set of vital signs to assess for hypotension and tachycardia.

Stopping rule: Anaphylaxis, or any other rapid decompensation not explained by a patient's concurrent conditions
At baseline and 30 minutes post application of CHG solution

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in pathogen colonization of participants receiving CHG cleansing: -1% vs 2% CHG -2x vs 5x weekly frequency
Time Frame: 2x/week cleansing within 96 hours after last CHG application; 5x/week cleansing within 72 hours after last CHG application

Trained research personnel will use flocked swabs to collect perirectal and umbilical swabs. For perirectal samples, the swab tip will be gently introduced around the anus. For skin samples, a single swab will be rubbed back-and-forth around the umbilicus. All swabs collected from neonates will be placed into transport media. The samples will be labeled with the infant's study number, source of sample and timing of sample.

At the National Health Laboratory microbiology section, swab specimens will be directly inoculated on chromogenic culture media which is selective and differential for select multidrug-resistant organisms (MDROs). MDRO isolates will then undergo confirmatory identification and sensitivity testing using the VITEK® 2 platform. Results will be available within 72 hrs of delivery to the laboratory.
2x/week cleansing within 96 hours after last CHG application; 5x/week cleansing within 72 hours after last CHG application
Reduction in bloodstream infection of participants receiving CHG cleansing: -1% vs 2% CHG -2x vs 5x weekly frequency
Time Frame: Within 30 days of initiating CHG intervention
Blood culture surveillance data will be extracted to determine incidence of blood stream infection within 30 days of initiating CHG intervention by enrollment band both ward-level and among study participants, stratified by weight/gestational age.
Within 30 days of initiating CHG intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Children's Hospital of Philadelphia
Imperial College London
Centers for Disease Control and Prevention
University of Utah
University of Botswana
Botswana-UPenn Partnership

Investigators

  • Principal Investigator: Ebbing Lautenbach, MD,MPH,MSCE, University of Pennsylvania
  • Principal Investigator: Susan Coffin, MD,MPH, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2025

Primary Completion (Actual)

March 19, 2025

Study Completion (Actual)

March 19, 2025

Study Registration Dates

First Submitted

May 29, 2024

First Submitted That Met QC Criteria

September 9, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 855362

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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