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Prevention of Nosocomial Infections (CleanKids) (CleanKids)

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ClinicalTrials.gov Identifier: NCT03360877
Recruitment Status : Active, not recruiting
First Posted : December 4, 2017
Last Update Posted : December 4, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Severe Acute Malnutrition Health Care Associated Infection Multi Drug Resistant Organisms Other: Health-care associated infection (HCAI)

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Assessing the Risk of Hospital-acquired Infection and Multi-drug Resistance Among Hospitalized Severe Acutely Malnourished Children
Actual Study Start Date : September 5, 2016
Estimated Primary Completion Date : December 15, 2017
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Health-care associated infection Other: Health-care associated infection (HCAI)
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


Outcome Measures

Primary Outcome Measures :
  1. Evaluation of the reduction of the incidence of nosocomial bacteremia [ Time Frame: Between 48 hours after hospitalization and less than 28 days after hospital release ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
More Information

Responsible Party: Epicentre
ClinicalTrials.gov Identifier: NCT03360877     History of Changes
Other Study ID Numbers: NE-949
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Malnutrition
Severe Acute Malnutrition
Cross Infection
Nutrition Disorders
Iatrogenic Disease
Disease Attributes
Pathologic Processes