Prevention of Nosocomial Infections (CleanKids) (CleanKids)
Primary Purpose
Severe Acute Malnutrition, Health Care Associated Infection, Multi Drug Resistant Organisms
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Health-care associated infection (HCAI)
Sponsored by
About this trial
This is an interventional prevention trial for Severe Acute Malnutrition
Eligibility Criteria
Inclusion Criteria:
- 6 to 59 months old
- severe acute malnutrition with medical complications
- parent / caregiver signing written informed consent
Exclusion Criteria:
- health condition that does not allow blood draw
- contraindication to the use of soap or Chlorhexidine gluconate, as recommended by the product
- refusal to discontinue the use of skin care products that are incompatible with Chlorhexidine gluconate according to the product's directions for use
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Health-care associated infection
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of the reduction of the incidence of nosocomial bacteremia
To determine whether, when accompanied by the caregiver, children with severe acute malnutrition (SAM), daily cleaning with wipes containing 2% chlorhexidine gluconate (HCG) reduces the incidence of nosocomial bacteremia suspected and / or confirmed by the laboratory compared to baseline data and compared to daily soap and water cleanup administered by the caregiver.
Secondary Outcome Measures
Full Information
NCT ID
NCT03360877
First Posted
November 28, 2017
Last Updated
August 13, 2019
Sponsor
Epicentre
Collaborators
Minisitry of Public Health, Niger, Medecins Sans Frontieres, Netherlands
1. Study Identification
Unique Protocol Identification Number
NCT03360877
Brief Title
Prevention of Nosocomial Infections (CleanKids)
Acronym
CleanKids
Official Title
Assessing the Risk of Hospital-acquired Infection and Multi-drug Resistance Among Hospitalized Severe Acutely Malnourished Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 5, 2016 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epicentre
Collaborators
Minisitry of Public Health, Niger, Medecins Sans Frontieres, Netherlands
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
While the standardization of treatment protocols for Severe Acute Malnutrition (SAM) has helped to reduce historically high mortality, mortality in inpatient settings remains substantial, likely due to the severity of complications associated with late presentation and health-care associated infection (HCAI).
The purpose of this study is to serve as an important stand-alone description to inform the understanding of the magnitude of the problem and help guide implementation of measures to reduce the risk of nosocomial infection and multi-drug resistance.
Detailed Description
This study is designed as a cross-sectional, non-randomized, two-site, four-phase study: an initial baseline period, two intervention periods, and a final interruption period.
This is a descriptive study to collect information on the risk of HCAIs in the MSF-supported inpatient nutritional treatment centers. Information on key clinical indicators will be collected regularly according to the routine program procedures from the time of admission to discharge. All children will undergo a blood draw for culture at time of admission and at the time of any suspected hospital-acquired bloodstream infection. As part of active surveillance for bacterial colonization, including multi-drug resistant organisms, all children will undergo nasal and rectal swabs at the time of admission, suspected infection, and discharge. Data will provide an estimate of nosocomial infection incidence under routine circumstances and inform sample size calculations if further study is warranted.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Malnutrition, Health Care Associated Infection, Multi Drug Resistant Organisms
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The initial 8-month baseline period will be used to collect data on the evaluation criteria of interest prior to the administration of any intervention of the study and will develop appropriate pedagogical tools to support the uptake of each cleaning strategy during subsequent intervention periods. After the reference period, a one-month introductory period will allow the organization of the first intervention at each site (ie - a soap and water cleansing administered by the carers in a structure or - a cleaning HCG administered by caregivers in the other facility) followed by eight months of active follow-up of the study with the first intervention. Following the eight months of active follow-up with the first intervention, there will be a crossover with an introductory period of one month and eight months of active follow-up with the other intervention. A final period of interruption will occur during the last eight months of the study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
4944 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Health-care associated infection
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Health-care associated infection (HCAI)
Intervention Description
Cleaning of the child with soap and water administered by the child's accompanying person in a structure or - a cleaning of the child with chlorhexidine gluconate administered by the child's accompanying person in the other structure
Primary Outcome Measure Information:
Title
Evaluation of the reduction of the incidence of nosocomial bacteremia
Description
To determine whether, when accompanied by the caregiver, children with severe acute malnutrition (SAM), daily cleaning with wipes containing 2% chlorhexidine gluconate (HCG) reduces the incidence of nosocomial bacteremia suspected and / or confirmed by the laboratory compared to baseline data and compared to daily soap and water cleanup administered by the caregiver.
Time Frame
Between 48 hours after hospitalization and less than 28 days after hospital release
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
6 to 59 months old
severe acute malnutrition with medical complications
parent / caregiver signing written informed consent
Exclusion Criteria:
health condition that does not allow blood draw
contraindication to the use of soap or Chlorhexidine gluconate, as recommended by the product
refusal to discontinue the use of skin care products that are incompatible with Chlorhexidine gluconate according to the product's directions for use
12. IPD Sharing Statement
Learn more about this trial
Prevention of Nosocomial Infections (CleanKids)
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