MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention

Malaria Clinical Trial

— MULTIPLY  

Official title:

MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05085340
• Other study ID #: RIA2020S 3272
• Status: Recruiting
• Start date: February 14, 2022
• Est. completion date: October 2025

Study information

• Verified date: May 2023
• Source: Barcelona Institute for Global Health
• Contact: Cristina Raya, MA
• Phone: +34 93 227 5400
• Email: cristina.raya[@]isglobal.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

As efforts to control malaria are stalling, and the disease is particularly severe in children under the age of two, it is imperative for countries in sub-Saharan Africa, with areas of moderate-to-high transmissions, to implement Perennial Malaria Chemoprevention (PMC) delivered through the Expanded Program on Immunization (EPI), which is the only feasible, sustainable and cost-effective strategy to reach this high-risk group. PMC is a full therapeutic course of antimalarial medicine (with sulfadoxine-pyrimethamine, SP) delivered to infants in the context of routine immunisation services during the first two year of life.

PMC has been shown to be safe, efficacious in reducing clinical malaria, anaemia and hospital admissions, and to be highly cost-effective; for all these reasons, the World Health Organization (WHO) recommended in 2010 Intermittent Preventive Treatment for Infants (IPTi) for malaria prevention. Only one African country - Sierra Leone -put IPTi into policy and practice. Concerned with this slow adoption, WHO in 2019 recommended adaptations be urgently tested through pilots assessing impact, operational feasibility and cost effectiveness. In 2022, WHO expanded that recommendation to cover children through the age of two because of studies documenting the value in children aged 12 to 24 months. The name for this preventive treatment has consequently changed to Perennial Malaria Chemoprevention (PMC) as the updated recommendation is no longer just for infants.

MULTIPLY is the pilot implementation of PMC in selected districts in Mozambique, Sierra Leone and Togo to maximise the delivery and uptake of PMC, to achieve the full potential of this intervention. Working with the ministries of health in Mozambique, Sierra Leone and Togo, MULTIPLY will give up to 6 doses of PMC in the first two years of life. PMC will be given at health facilities and EPI mobile outreach clinics using a paediatric dispersible formulation of SP, alongside routine vaccinations and vitamin A supplementation.

Description:

The study will be conducted in 3 sub-Saharan African countries; Sierra Leone, Mozambique and Togo.

Sample size; Assuming an average population of a district/project area of 150,000 inhabitants and a percentage of U2 children of 5%, the project intervention will target approximately 45,000 U2 children in total (i.e. 7,500 children per country and per year for 2 years).

Study population; Children U2 who are eligible for IPTi in the selected MULTIPLY district of each country.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45000
• Est. completion date: October 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Weeks to 18 Months

Eligibility

Inclusion Criteria:

All infants attending their 2nd EPI contact who are eligible to receive the corresponding immunisations.

Exclusion Criteria:

Infants/children; with acute malaria; known to have sulfa allergies; who have taken SP in the past 4 weeks; who are HIV-exposed or HIV-infected

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Intermittent preventive treatment of malaria in infants (IPTi) with sulfadoxine-pyrimethamine (SP)
IPTi will be administered as full therapeutic courses of SP alongside routine EPI immunisations at defined intervals corresponding to vaccination schedules - usually at 10 weeks, 14 weeks, and 9 months of age - to infants living in project districts. Additional doses of IPTi will be administered at 6, 12, and 15 or 18 months of age, coinciding with vitamin A administration and measles booster immunisation. The number of doses of IPTi a child will receive will depend of the EPI schedule in the country, with a maximum of six doses in the first two years of life.

Locations

Country	Name	City	State
Mozambique	Fundaçao Manhiça	Manhiça
Sierra Leone	College of Medicine & Allied Health Sciences (COMAHS), University of Sierra Leone	Freetown
Togo	University of Lomé	Lomé

Sponsors (6)

Lead Sponsor	Collaborator
Barcelona Institute for Global Health	Centro de Investigação em Saúde de Manhiça, Institut de Recherche pour le Developpement, Medicines for Malaria Venture, University of Lomé (UL), Togo, University of Sierra Leone

Countries where clinical trial is conducted

Mozambique,  Sierra Leone,  Togo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children having received at least three doses of IPTi		Month 24
Secondary	Malaria prevalence in under 2 year old children living in project districts		Month 24
Secondary	Malaria incidence in under 2 year old children living in project districts		Month 24
Secondary	Coverage of EPI routine vaccines in children living in project districts		Month 24