Multidrug Resistant Bacterial InfectionCHARMNCT06590675
Development and Evaluation of a ChlorHexidine Gluconate bAthing pRotocol for Healthcare Settings in Low- and Middle-income Countries
A study testing Chlorhexidine Gluconate (CHG) in people with Multidrug Resistant Bacterial Infection, run by University of Pennsylvania at 1 site in Botswana.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 6 daysHealthy volunteers can take part
- Conditions the study is for
- Multidrug Resistant Bacterial Infection
- What is being tested?
- Chlorhexidine Gluconate (CHG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBotswana
- Study dates
- 19 Feb 2025to 19 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Neonates 1-6 days old admitted to the neo-natal unit expected to stay at least 7 days
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- develop a low-cost, standardized protocol for CHG bathing in the ICU and NNU
- assess safety of local CHG preparation among hospitalized neonates
- determine the efficacy of CHG bathing using the developed protocol to reduce bacterial colonization and healthcare-associated infection (HAI) burden in hospitalized patients
- 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.
- Conditions
- Multidrug Resistant Bacterial Infection
- Being tested
- Chlorhexidine Gluconate (CHG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine Gluconate (CHG)Drug
Also called Aqueous CHG
A locally-prepared CHG formulation as a 1% or 2% solution
| Study group | Role | What they receive |
|---|---|---|
| ≥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) Receives: 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) Receives: 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) Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
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.
Measured: 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
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.
Measured: Within 30 days of initiating CHG intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Feb 2025
- Primary completion19 Mar 2025
- Study completion19 Mar 2025
Why it stopped: Funding Withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Multidrug Resistant Bacterial InfectionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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).
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, University of Botswana, Centers for Disease Control and Prevention, University of Utah, Imperial College London, Botswana-UPenn Partnership
- Responsible party
- Principal investigator, Ebbing Lautenbach, University of Pennsylvania
- Investigators
- Ebbing Lautenbach, MD,MPH,MSCE, Principal investigator, University of PennsylvaniaSusan Coffin, MD,MPH, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590675
- Sponsor's protocol ID
- 855362
- Acronym
- CHARM
- Status last verified
- Jun 2025
- First submitted
- 29 May 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33227511Kabwe 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.
PubMed 27031259Flokas 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.
PubMed 28141845Strysko 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
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.
PubMed 30830952Mwananyanda 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.
PubMed 30596901Dramowski 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.
PubMed 34195575Musuuza 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.
PubMed 32330165Silvestri DL, McEnery-Stonelake M. Chlorhexidine: uses and adverse reactions. Dermatitis. 2013 May-Jun;24(3):112-8. doi: 10.1097/DER.0b013e3182905561.
PubMed 23665831Garland 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.
PubMed 11389271Visscher 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.
PubMed 19693022Darmstadt 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.
PubMed 15295221Mullany 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.
PubMed 18449064Krautheim 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.
PubMed 15153122
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a ChlorHexidine Gluconate bAthing pRotocol for Healthcare Settings in Low- and Middle-income Countries
- ClinicalTrials.gov ID
- NCT06590675
- Acronym / sponsor ID
- CHARM / 855362
- Conditions
- Multidrug Resistant Bacterial Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding Withdrawn
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, University of Botswana, Centers for Disease Control and Prevention, University of Utah, Imperial College London, Botswana-UPenn Partnership
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- develop a low-cost, standardized protocol for CHG bathing in the ICU and NNU
- assess safety of local CHG preparation among hospitalized neonates
- determine the efficacy of CHG bathing using the developed protocol to reduce bacterial colonization and healthcare-associated infection (HAI) burden in hospitalized patients
- 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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- 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).
| Arm | Type | Receives |
|---|---|---|
| ≥34 Week Neonates & ≥1.4 kg | Experimental | Drug: 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 | Experimental | Drug: 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 | Experimental | Drug: 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) |
| 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). |
Who may qualify
- Ages
- 1 day to 6 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates 1-6 days old admitted to the neo-natal unit expected to stay at least 7 days
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine Gluconate (CHG)Also: Aqueous CHGA locally-prepared CHG formulation as a 1% or 2% solution | Drug | ≥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 |
Primary outcome
Safety of locally prepared 1% and 2% chlorhexidine gluconate (CHG) cleansing: Skin integrity
Time frame: 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
Time frame: 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
2 secondary outcomes
Reduction in pathogen colonization of participants receiving CHG cleansing: -1% vs 2% CHG -2x vs 5x weekly frequency
Time frame: 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
Time frame: Within 30 days of initiating CHG intervention
Results and safety
The study was stopped early (reason given: Funding Withdrawn). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Background: PubMed 33227511Gezmu 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: PubMed 27031259Kabwe 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: PubMed 28141845Flokas 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.
- BackgroundStrysko 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: PubMed 30830952Kagia 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: PubMed 30596901Mwananyanda 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: PubMed 34195575Dramowski 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: PubMed 32330165Musuuza 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: PubMed 23665831Silvestri DL, McEnery-Stonelake M. Chlorhexidine: uses and adverse reactions. Dermatitis. 2013 May-Jun;24(3):112-8. doi: 10.1097/DER.0b013e3182905561.
- Background: PubMed 11389271Garland 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: PubMed 19693022Visscher 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: PubMed 15295221Darmstadt 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.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Aztreonam-Avibactam in Immunocompromised Hosts
Enterobacteriaceae Infections, Carbapenem-Resistant Enterobacteriaceae Infection
RecruitingObservational study
Bioneer Q-RFIA Clinical Evaluation
Tuberculosis, Multidrug-Resistant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebbing Lautenbach, MD,MPH,MSCE principal investigator
University of Pennsylvania
Susan Coffin, MD,MPH principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine Gluconate (CHG) in people with Multidrug Resistant Bacterial Infection, run by University of Pennsylvania at 1 site in Botswana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding Withdrawn). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of locally prepared 1% and 2% chlorhexidine gluconate (CHG) cleansing: Skin integrity (time frame: At baseline and 30 minutes post application of CHG solution). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06590675, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.