drugset / Trial / NCT06590675
Development and Evaluation of a ChlorHexidine Gluconate bAthing pRotocol for Healthcare Settings in Low- and Middle-income Countries
Terminated
19 enrolled
University of Pennsylvania
Botswana-UPenn Partnership · collabCenters for Disease Control and Prevention · collabChildren's Hospital of Philadelphia · collabImperial College London · collabUniversity of Botswana · collabUniversity of Utah · collab
Non-randomizedSequentialOpen-labelPrevention
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.
Timeline
- Start
- 2025-02-19
- Primary completion
- 2025-03-19
- Completion
- 2025-03-19
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Background Silvestri DL, McEnery-Stonelake M. Chlorhexidine: uses and adverse reactions. Dermatitis. 2013 May-Jun;24(3):112-8. doi: 10.1097/DER.0b013e3182905561.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Chlorhexidine gluconate | Other / unclassified | 1 % | Topical |
| Subject | Chlorhexidine gluconate | Other / unclassified | 2 % | Topical |