Prevention of Nosocomial Infections (CleanKids)

• Sponsor: Epicentre (Other)
• Overall Status: Completed
• CT.gov ID: NCT03360877
• Collaborator: Minisitry of Public Health, Niger (Other), Medecins Sans Frontieres, Netherlands (Other)
• Enrollment: 4,944
• Arm: 1
• Actual Duration (Months): 33.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Acute Malnutrition; Health Care Associated Infection; Multi Drug Resistant Organisms	Other: Health-care associated infection (HCAI)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4944 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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.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.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Assessing the Risk of Hospital-acquired Infection and Multi-drug Resistance Among Hospitalized Severe Acutely Malnourished Children
• Actual Study Start Date: Sep 5, 2016
• Actual Primary Completion Date: Nov 30, 2017
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Health-care associated infection	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

Outcome Measures

Primary Outcome Measures

1. Evaluation of the reduction of the incidence of nosocomial bacteremia [Between 48 hours after hospitalization and less than 28 days after hospital release]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 59 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Epicentre
• ClinicalTrials.gov Identifier: NCT03360877
• Other Study ID Numbers: NE-949
• First Posted: Dec 4, 2017
• Last Update Posted: Aug 14, 2019
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Cross Infection; Malnutrition; Severe Acute Malnutrition

Study Results

No Results Posted as of Aug 14, 2019