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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03360877
Other study ID # NE-949
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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