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

NCT06590675 | Terminated DMC

• 1 other identifier: 855362
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Multidrug Resistant Bacterial Infection

Outcome Measures

Primary Outcomes (2)

• Safety of locally prepared 1% and 2% chlorhexidine gluconate (CHG) cleansing: Skin integrity

  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

  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 Outcomes (2)

• 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

• 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

Study Arms (4)

≥34 Week Neonates & ≥1.4 kg

EXPERIMENTAL

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)

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

EXPERIMENTAL

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)

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

EXPERIMENTAL

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)

Feasibility Assessment

NO INTERVENTION

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).

Interventions

Chlorhexidine Gluconate (CHG) DRUG

A locally-prepared CHG formulation as a 1% or 2% solution

Also known as: Aqueous CHG

≥28 Week Neonates &/or 1.0 kg - 1.2 kg; ≥32 Week Neonates &/or 1.2 kg - 1.4 kg; ≥34 Week Neonates & ≥1.4 kg

Eligibility Criteria

• Age: 1 Day - 6 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Princess Marina Hospital

Gaborone, Botswana

Location

Related Publications (14)

• Gezmu AM, Bulabula ANH, Dramowski A, Bekker A, Aucamp M, Souda S, Nakstad B. Laboratory-confirmed bloodstream infections in two large neonatal units in sub-Saharan Africa. Int J Infect Dis. 2021 Feb;103:201-207. doi: 10.1016/j.ijid.2020.11.169. Epub 2020 Nov 20.

  PMID: 33227511 BACKGROUND

• Kabwe M, Tembo J, Chilukutu L, Chilufya M, Ngulube F, Lukwesa C, Kapasa M, Enne V, Wexner H, Mwananyanda L, Hamer DH, Sinyangwe S, Ahmed Y, Klein N, Maeurer M, Zumla A, Bates M. Etiology, Antibiotic Resistance and Risk Factors for Neonatal Sepsis in a Large Referral Center in Zambia. Pediatr Infect Dis J. 2016 Jul;35(7):e191-8. doi: 10.1097/INF.0000000000001154.

  PMID: 27031259 BACKGROUND

• Flokas ME, Karanika S, Alevizakos M, Mylonakis E. Prevalence of ESBL-Producing Enterobacteriaceae in Pediatric Bloodstream Infections: A Systematic Review and Meta-Analysis. PLoS One. 2017 Jan 31;12(1):e0171216. doi: 10.1371/journal.pone.0171216. eCollection 2017.

  PMID: 28141845 BACKGROUND

• Strysko J, Machiya T, Lechiile K, et al. Carbapenem-resistant Acinetobacter baumannii at a tertiary-care hospital in Botswana: Focus on perinatal environmental exposures. (2022). Antimicrobial Stewardship & Healthcare Epidemiology, 2(S1), S79-S79. doi:10.1017/ash.2022.206

  BACKGROUND

• Kagia N, Kosgei P, Ooko M, Wafula L, Mturi N, Anampiu K, Mwarumba S, Njuguna P, Seale AC, Berkley JA, Bottomley C, Scott JAG, Morpeth SC. Carriage and Acquisition of Extended-spectrum beta-Lactamase-producing Enterobacterales Among Neonates Admitted to Hospital in Kilifi, Kenya. Clin Infect Dis. 2019 Aug 16;69(5):751-759. doi: 10.1093/cid/ciy976.

  PMID: 30830952 BACKGROUND

• Mwananyanda L, Pierre C, Mwansa J, Cowden C, Localio AR, Kapasa ML, Machona S, Musyani CL, Chilufya MM, Munanjala G, Lyondo A, Bates MA, Coffin SE, Hamer DH. Preventing Bloodstream Infections and Death in Zambian Neonates: Impact of a Low-cost Infection Control Bundle. Clin Infect Dis. 2019 Sep 27;69(8):1360-1367. doi: 10.1093/cid/ciy1114.

  PMID: 30596901 BACKGROUND

• Dramowski A, Pillay S, Bekker A, Abrahams I, Cotton MF, Coffin SE, Whitelaw AC. Impact of 1% chlorhexidine gluconate bathing and emollient application on bacterial pathogen colonization dynamics in hospitalized preterm neonates - A pilot clinical trial. EClinicalMedicine. 2021 Jun 18;37:100946. doi: 10.1016/j.eclinm.2021.100946. eCollection 2021 Jul.

  PMID: 34195575 BACKGROUND

• Musuuza JS, Roberts TJ, Hundt AS, Carayon P, Zimbric ML, Schuetz V, Reppen M, Smith W, Koffarnus K, Brown RL, Bowling J, Jalali K, Safdar N. Implementing daily chlorhexidine gluconate treatment for the prevention of healthcare-associated infections in non-intensive care settings: A multiple case analysis. PLoS One. 2020 Apr 24;15(4):e0232062. doi: 10.1371/journal.pone.0232062. eCollection 2020.

  PMID: 32330165 BACKGROUND

• Silvestri DL, McEnery-Stonelake M. Chlorhexidine: uses and adverse reactions. Dermatitis. 2013 May-Jun;24(3):112-8. doi: 10.1097/DER.0b013e3182905561.

  PMID: 23665831 BACKGROUND

• Garland JS, Alex CP, Mueller CD, Otten D, Shivpuri C, Harris MC, Naples M, Pellegrini J, Buck RK, McAuliffe TL, Goldmann DA, Maki DG. A randomized trial comparing povidone-iodine to a chlorhexidine gluconate-impregnated dressing for prevention of central venous catheter infections in neonates. Pediatrics. 2001 Jun;107(6):1431-6. doi: 10.1542/peds.107.6.1431.

  PMID: 11389271 BACKGROUND

• Visscher M, deCastro MV, Combs L, Perkins L, Winer J, Schwegman N, Burkhart C, Bondurant P. Effect of chlorhexidine gluconate on the skin integrity at PICC line sites. J Perinatol. 2009 Dec;29(12):802-7. doi: 10.1038/jp.2009.116. Epub 2009 Aug 20.

  PMID: 19693022 BACKGROUND

• Darmstadt GL, Badrawi N, Law PA, Ahmed S, Bashir M, Iskander I, Al Said D, El Kholy A, Husein MH, Alam A, Winch PJ, Gipson R, Santosham M. Topically applied sunflower seed oil prevents invasive bacterial infections in preterm infants in Egypt: a randomized, controlled clinical trial. Pediatr Infect Dis J. 2004 Aug;23(8):719-25. doi: 10.1097/01.inf.0000133047.50836.6f.

  PMID: 15295221 BACKGROUND

• Mullany LC, Khatry SK, Sherchand JB, LeClerq SC, Darmstadt GL, Katz J, Gauchan P, Adhikari RK, Rana A, Tielsch JM. A randomized controlled trial of the impact of chlorhexidine skin cleansing on bacterial colonization of hospital-born infants in Nepal. Pediatr Infect Dis J. 2008 Jun;27(6):505-11. doi: 10.1097/INF.0b013e31816791a2.

  PMID: 18449064 BACKGROUND

• Krautheim AB, Jermann TH, Bircher AJ. Chlorhexidine anaphylaxis: case report and review of the literature. Contact Dermatitis. 2004 Mar;50(3):113-6. doi: 10.1111/j.0105-1873.2004.00308.x.

  PMID: 15153122 BACKGROUND

MeSH Terms

Interventions

chlorhexidine gluconate

Study Officials

• Ebbing Lautenbach, MD,MPH,MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Susan Coffin, MD,MPH

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: September 19, 2024
• Study Start: February 19, 2025
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)