Clinical trial NCT03360877: Prevention of Nosocomial Infections (CleanKids)
Official title: Assessing the Risk of Hospital-acquired Infection and Multi-drug Resistance Among Hospitalized Severe Acutely Malnourished Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Acute Malnutrition
Health Care Associated Infection
Multi Drug Resistant Organisms
Lead sponsor: Epicentre
Sponsor class: OTHER
Collaborators: name: Minisitry of Public Health, Niger
name: Medecins Sans Frontieres, Netherlands
First posted: 2017-12-04
Enrollment: 4944
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The initial 8-month baseline period will be used to collect data on the evaluation criteria of interest prior to the administration of any intervention of the study and will develop appropriate pedagogical tools to support the uptake of each cleaning strategy during subsequent intervention periods. After the reference period, a one-month introductory period will allow the organization of the first intervention at each site (ie - a soap and water cleansing administered by the carers in a structure or - a cleaning HCG administered by caregivers in the other facility) followed by eight months of active follow-up of the study with the first intervention. Following the eight months of active follow-up with the first intervention, there will be a crossover with an introductory period of one month and eight months of active follow-up with the other intervention. A final period of interruption will occur during the last eight months of the study.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the reduction of the incidence of nosocomial bacteremia
timeFrame: Between 48 hours after hospitalization and less than 28 days after hospital release
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: