NCT03360877

Prevention of Nosocomial Infections (CleanKids)

Assessing the Risk of Hospital-acquired Infection and Multi-drug Resistance Among Hospitalized Severe Acutely Malnourished Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,944 (actual)
• Sponsor: Epicentre · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Acute Malnutrition
• Health Care Associated Infection
• Multi Drug Resistant Organisms

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-09-05
• Primary completion: 2017-11-30
• Completion: 2019-06-30
• First posted: 2017-12-04
• Last updated: 2019-08-14