Prevention of Nosocomial Infections (CleanKids)

Severe Acute Malnutrition Clinical Trial

— CleanKids  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03360877
• Other study ID #: NE-949
• Status: Completed
• Phase: N/A
• Start date: September 5, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: Epicentre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4944
• Est. completion date: June 30, 2019
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Epicentre	Medecins Sans Frontieres, Netherlands, Minisitry of Public Health, Niger

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Between 48 hours after hospitalization and less than 28 days after hospital release