Prevention of Nosocomial Infections (CleanKids)

Not Applicable

Completed

• Conditions: Severe Acute Malnutrition; Health Care Associated Infection; Multi Drug Resistant Organisms
• Interventions: Other: Health-care associated infection (HCAI)

• Registration Number: NCT03360877
• Lead Sponsor: Epicentre

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.

Study Timeline

• Study Start: 2016-09-05
• Study First Submitted: 2017-11-28
• Primary Completion: 2017-11-30
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-04
• Study Completion: 2019-06-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4944

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Health-care associated infection	Health-care associated infection (HCAI)	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the reduction of the incidence of nosocomial bacteremia	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.