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

University of Pennsylvania

Status: Terminated

Conditions: Multidrug Resistant Bacterial Infection

Treatments: Drug: Chlorhexidine Gluconate (CHG)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06590675

855362

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 1 to 6 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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19 participants in 4 patient groups

≥34 Week Neonates & ≥1.4 kg

Experimental group

Description:

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)

Treatment:

Drug: Chlorhexidine Gluconate (CHG)

≥32 Week Neonates &/or 1.2 kg - 1.4 kg

Experimental group

Description:

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)

Treatment:

Drug: Chlorhexidine Gluconate (CHG)

≥28 Week Neonates &/or 1.0 kg - 1.2 kg

Experimental group

Description:

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)

Treatment:

Drug: Chlorhexidine Gluconate (CHG)

Feasibility Assessment

No Intervention group

Description:

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).