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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
Epicentre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Severe Acute Malnutrition

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 6 to 59 months old
  2. severe acute malnutrition with medical complications
  3. parent / caregiver signing written informed consent

Exclusion Criteria:

  1. health condition that does not allow blood draw
  2. contraindication to the use of soap or Chlorhexidine gluconate, as recommended by the product
  3. 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

    First Posted
    November 28, 2017
    Last Updated
    August 13, 2019
    Sponsor
    Epicentre
    Collaborators
    Minisitry of Public Health, Niger, Medecins Sans Frontieres, Netherlands
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    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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