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Severe Acute MalnutritionTISANCT04667767

The TISA Trial - Senegal

A study testing WASH kit and Standard treatment in people with Severe Acute Malnutrition, run by London School of Hygiene and Tropical Medicine at 1 site in Senegal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 6 to 59 months
Conditions the study is for
Severe Acute Malnutrition
What is being tested?
WASH kit and Standard treatment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,411 participants
Where
1 siteSenegal
Study dates
22 Dec 2020to 27 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 59 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Senegal1 site

  • ACF Senegal

    Louga

Other trials in Senegal

About this study

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

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.

Read the detailed 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.

Being tested
WASH kit, Standard treatment
Medical subject headings
Severe Acute Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WASH kitOther

    WASH kit containing a plastic container and a supply of Aquatabs® (effervescent chlorine tablets) and training in their use and associated hygiene practices.

  • Standard treatmentOther

    National standard outpatient treatment for uncomplicated severe acute malnutrition

Study groups in NCT04667767
Study groupRoleWhat they receive
InterventionExperimentalIn addition to the national standard outpatient treatment for uncomplicated severe acute malnutrition, caregivers of participants will receive a "WASH kit" containing a plastic container, a supply of Aquatabs® (effervescent chlorine tablets), and training in their use and associated hygiene practices.
Receives: Other: WASH kit
ControlActive comparatorNational standard outpatient treatment for uncomplicated severe acute malnutrition
Receives: Other: Standard treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 weeks

Secondary outcomes (5)

  1. Weight gain

    Weight gain defined as grams of weight gained per kilogram per day between entry and exit.

    Measured: 8 weeks

  2. Rate of referral

    Referral rate defined as number of participants referred/transferred to next level of care.

    Measured: 8 weeks

  3. 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).

    Measured: 8 weeks

  4. 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.

    Measured: 8 weeks

  5. All cause mortality

    Deaths occurring during follow-up due to any cause.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2020
  2. Study start22 Dec 2020
  3. Primary completion27 Apr 2023
  4. Study completion27 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,411 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04667767
Sponsor's protocol ID
2019-KEP-267
Acronym
TISA
Status last verified
Jan 2024
First submitted
8 Dec 2020
Last updated
25 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication will be shared

Publications

  • N'Diaye DS, Frison S, Ba M, Le ML, Cabo AE, Siroma F, Devort A, MacLeod C, Lapegue J, Seye M, Traore AB, Cerveau T, Leger D, Gallandat K, Gnokane Y, Brizuela AV, Stern S, Braun L, Cumming O. Implementing a pragmatic randomised controlled trial in a humanitarian setting: lessons learned from the TISA trial. Trials. 2024 Sep 19;25(1):620. doi: 10.1186/s13063-024-08459-1.

    PubMed 39300465

Questions about this trial

What is this clinical trial studying?

A study testing WASH kit and Standard treatment in people with Severe Acute Malnutrition, run by London School of Hygiene and Tropical Medicine at 1 site in Senegal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of recovery (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04667767, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.

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