Prevention of Nosocomial Infections (CleanKids)

Epicentre

Status: Completed

Conditions: Multi Drug Resistant Organisms; Severe Acute Malnutrition; Health Care Associated Infection

Treatments: Other: Health-care associated infection (HCAI)

Study type: Interventional

Funder types: Other

Identifiers

NCT03360877

NE-949

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,944 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4,944 participants in 1 patient group

Health-care associated infection

Other group

Treatment:

Other: Health-care associated infection (HCAI)