Prevention of Nosocomial Infections (CleanKids)

NCT03360877 | Completed

• 1 other identifier: NE-949
• Study Type: interventional
• Target: 4,944
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Health-care associated infection

OTHER

Other: Health-care associated infection (HCAI)

Interventions

Health-care associated infection (HCAI) OTHER

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

Health-care associated infection

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 59 months old
• severe acute malnutrition with medical complications
• parent / caregiver signing written informed consent

You may not qualify if:

• health condition that does not allow blood draw
• contraindication to the use of soap or Chlorhexidine gluconate, as recommended by the product
• refusal to discontinue the use of skin care products that are incompatible with Chlorhexidine gluconate according to the product's directions for use

Sponsors & Collaborators

• Epicentre: lead
• Minisitry of Public Health, Niger: collaborator
• Medecins Sans Frontieres, Netherlands: collaborator

MeSH Terms

Conditions

Severe Acute Malnutrition; Cross Infection

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 4, 2017
• Study Start: September 5, 2016
• Primary Completion: November 30, 2017
• Study Completion: June 30, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08