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: August 2024

Study information

• Verified date: March 2022
• 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

MULTIPLY is a multi-country 40-month implementation research project, which aims to catalyse country uptake of Intermittent Preventive Treatment of malaria in infants (IPTi) and inform future policy and guidelines in moderate-to-high malaria transmission settings. The project has been conceived following a before-after evaluation design of the impact of the intervention. The primary outcome measure will be the coverage of three or more doses of IPTi in children under 2 years of age (U2) attending the Expanded Programme on Immunisation (EPI) in project areas. IPTi will be delivered at health facilities and mobile-outreach EPI clinics to all children living in project districts. The number of IPTi doses a child will receive will be based on the EPI schedule of the country, with a maximum of 6 doses in the first 2 years of life. The prophylactic effect of IPTi provides protection for up to 6 weeks in infants. Therefore, in the current WHO-recommended IPTi scheme, infants are exposed to the infection for about 4 months during a critical period of high susceptibility to harmful effects of the infection. Exploiting additional opportunities to administer IPTi to children in their first years of life could be of great public health interest. In settings where vitamin A deficiency is a public health problem WHO recommends vitamin A supplementation, habitually done through the EPI scheme starting at 6 months of age, at 6 months intervals; thus, the addition of IPTi at 6, 12, 15-18 months of age to vitamin A administration would improve malaria prevention during a critical time in the first year of life and expand it into the second. Moreover, the integration of these two interventions might help increase the coverage of vitamin A supplementation, which ranges between 53%-57% in sub-Saharan Africa and importantly will help reduce the prevalence of anaemia in young children by combining the effect of malaria prevention and of vitamin A on increasing haemoglobin levels. Additionally, in recent years the inclusion of a booster dose of measles immunisation in the EPI, between 15-18 months of age, also offers the opportunity of further expanding malaria protection in the second year of life using IPTi. This is particularly relevant given that severe malaria cases are more prevalent between 1 and 3 years of age in high and moderate transmission areas.

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: August 2024
• Est. primary completion date: February 2023
• 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