Clinical trial NCT06590675: Development and Evaluation of a ChlorHexidine Gluconate bAthing pRotocol for Healthcare Settings in Low- and Middle-income Countries
Official title: Development and Evaluation of a ChlorHexidine Gluconate bAthing pRotocol for Healthcare Settings in Low- and Middle-income Countries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multidrug Resistant Bacterial Infection
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: University of Botswana
name: Centers for Disease Control and Prevention
name: University of Utah
name: Imperial College London
name: Botswana-UPenn Partnership
First posted: 2024-09-19
Enrollment: 270
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is 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 neonatal unit (NNU) and intensive care unit (ICU).
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety of locally prepared 1% and 2% chlorhexidine gluconate (CHG) cleansing: Skin integrity
timeFrame: At baseline and 30 minutes post application of CHG solution
measure: Safety of locally prepared 1% and 2% CHG cleansing: Systemic responses
timeFrame: At baseline and 30 minutes post application of CHG solution
Secondary outcomes:
measure: Reduction in pathogen colonization of participants receiving CHG cleansing: -1% vs 2% CHG -2x vs 5x weekly frequency
timeFrame: 2x/week cleansing within 96 hours after last CHG application; 5x/week cleansing within 72 hours after last CHG application
measure: Reduction in bloodstream infection of participants receiving CHG cleansing: -1% vs 2% CHG -2x vs 5x weekly frequency
timeFrame: Within 30 days of initiating CHG intervention
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Princess Marina Hospital
Study officials:
affiliation: University of Pennsylvania
name: Ebbing Lautenbach, MD,MPH,MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Susan Coffin, MD,MPH
role: PRINCIPAL_INVESTIGATOR
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