Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590675
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-29
Brief Title:
Development and Evaluation of a ChlorHexidine Gluconate bAthing pRotocol for Healthcare Settings in Low- and Middle-income Countries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development and Evaluation of a ChlorHexidine Gluconate bAthing pRotocol for Healthcare Settings in Low- and Middle-income Countries
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHARM
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None