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

Not Applicable

Not yet recruiting

• Conditions: Multidrug Resistant Bacterial Infection
• Interventions: Drug: Chlorhexidine Gluconate (CHG)

• Registration Number: NCT06590675
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study First Submitted: 2024-05-29
• Study First Submitted QC: 2024-09-09
• Study First Posted: 2024-09-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Study Start: 2025-01
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
≥34 Week Neonates & ≥1.4 kg	Chlorhexidine Gluconate (CHG)	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)
≥32 Week Neonates &/or 1.2 kg - 1.4 kg	Chlorhexidine Gluconate (CHG)	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)
≥28 Week Neonates &/or 1.0 kg - 1.2 kg	Chlorhexidine Gluconate (CHG)	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)

Primary Outcome Measures

Name	Time	Method
Safety of locally prepared 1% and 2% chlorhexidine gluconate (CHG) cleansing: Skin integrity	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)
Safety of locally prepared 1% and 2% CHG cleansing: Systemic responses	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

Secondary Outcome Measures

Name	Time	Method
Reduction in pathogen colonization of participants receiving CHG cleansing: -1% vs 2% CHG -2x vs 5x weekly frequency	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.
Reduction in bloodstream infection of participants receiving CHG cleansing: -1% vs 2% CHG -2x vs 5x weekly frequency	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.

Trial Locations

Locations (1)

Princess Marina Hospital; 🇧🇼 Gaborone, Botswana