The TISA Trial - Senegal

Severe Acute Malnutrition Clinical Trial

— TISA  

Official title:

TISA (Traitement Intégré de la Sous-Nutrition Aiguë) Trial : A Cluster Randomized Controlled Trial for the Effect of a WASH Kit Combined With Standard Outpatient Treatment on Severe Acute Malnutrition Recovery in Senegal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04667767
• Other study ID #: 2019-KEP-267
• Status: Completed
• Phase: N/A
• Start date: December 22, 2020
• Est. completion date: April 27, 2023

Study information

• Verified date: January 2024
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the addition of a simple, scalable "WASH kit", including household water treatment products, a safe water storage container, and hygiene promotion, to the standard national protocol for outpatient treatment of uncomplicated severe acute malnutrition among children aged 6-59 months of age in northern Senegal.

Description:

Severe acute malnutrition (SAM) is defined as a weight-for-height z-score (WHZ) below -3 of the World Health Organisation growth standards. It is a short-term acute condition with a high case-fatality rate that increases both the susceptibility of children to infection and the risk of mortality. The global prevalence of SAM in children is estimated to be over 17 million with most of those affected living in sub-Saharan Africa and Asia. Community-Based Management of Acute Malnutrition (CMAM) has significantly changed standard practice for the treatment of SAM. Uncomplicated SAM cases are now predominantly managed on an outpatient basis and Action Contre la Faim (ACF) supports outpatient treatment programs (OTP) across the globe, particularly in Africa and Asia. This innovation has increased coverage, and reduced the cost of treatment for both the health system and individuals. However, under CMAM, the treatment context has moved from a more controlled health facility setting to the generally less controlled household setting where the risk of infection due to environmental hazards, such as contaminated water, may be higher. The TISA trial described here will evaluate the effectiveness of combining a simple, scalable "WASH kit" with OTP on the recovery rate among uncomplicated SAM cases aged 6-59 compared to the national standard OTP. The WASH kit includes a plastic container, a supply of Aquatabs® (effervescent chlorine tablets), and training in their use and associated hygiene practices. The study is a cluster randomized controlled trial (cRCT), with health centres constituting the clusters. Clusters are randomly allocated to either a control group receiving the standard OTP or an intervention group receiving OTP plus the WASH kit. The primary outcome of the trial is the recovery rate and the secondary outcomes are weight gain, referral rate, longitudinal prevalence of diarrhoea, prevalence of enteric pathogen detection and all-cause mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2411
• Est. completion date: April 27, 2023
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• Weight-for-height z-score <-3; or
• Brachial perimeter (mid-upper arm circumference) <115; or
• Bilateral oedema

Exclusion Criteria:

• Not able and/or willing to participate for up to 8-weeks
• Clinical complications requiring referral and/or inpatient treatment

Related Conditions & MeSH terms

• Malnutrition
• Severe Acute Malnutrition

Intervention

Other:
• WASH kit
WASH kit containing a plastic container and a supply of Aquatabs® (effervescent chlorine tablets) and training in their use and associated hygiene practices.
• Standard treatment
National standard outpatient treatment for uncomplicated severe acute malnutrition

Locations

Country	Name	City	State
Senegal	ACF Senegal	Louga

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Action Contre la Faim, Cheikh Anta Diop University, Senegal

Country where clinical trial is conducted

Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recovery	Recovery defined as two consecutive weeks with weight-for-height z-scores = -1.5, if admitted based on weight-for-height z-score, or brachial perimeter (mid-upper arm circumference) = 125 mm, if admitted based on brachial perimeter, and no oedema.	8 weeks
Secondary	Weight gain	Weight gain defined as grams of weight gained per kilogram per day between entry and exit.	8 weeks
Secondary	Rate of referral	Referral rate defined as number of participants referred/transferred to next level of care.	8 weeks
Secondary	Longitudinal prevalence of diarrhoea	Longitudinal prevalence is defined by weeks with diarrhoea during follow-up with diarrhoea defined according to WHO definition (3 or more loose or liquid stools passed within 24 hours).	8 weeks
Secondary	Prevalence of enteric pathogen detection	Enteric pathogen detection by stool-based molecular assays of following pathogens: Adenovirus F(40/41), Astrovirus, Norovirus GI, Norovirus GII, Rotavirus, Sapovirus, Enteroaggregative E. coli (EAEC), Shiga-like toxin producing E. coli (STEC), Enteropathogenic Escherichia coli (EPEC), Enterotoxigenic E. coli (ETEC), Shigella/ Enteroinvasive Escherichia coli (EIEC), Campylobacter jejuni/coli, Salmonella enterica, Salmonella enterica Typhi, Vibrio cholerae, Clostridioides difficile, Yersinia enterocolitica, E. coli O157, Aeromonas, Helicobacter pylori, Cryptosporidium spp., Giardia spp., Entamoeba histolytica, Ascaris lumbricoides, Trichuris trichiura, Ancylostoma duodenale, Necator americanus, Strongyloides stercolaris, Plesiomonas shigelloides, Shigella flexneri, Shigella sonnei, Cyclospora cayetanensis.	8 weeks
Secondary	All cause mortality	Deaths occurring during follow-up due to any cause.	8 weeks