Perennial Malaria Chemoprevention (PMC) in Cameroon

Anemia Clinical Trial

Official title:

Impact Evaluation of Intermittent Preventive Treatment of Malaria in Infants Plus (IPTi+) in Cameroon: The Plus Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05889052
• Other study ID #: PLUS-27988-CAM
• Status: Recruiting
• Start date: July 19, 2023
• Est. completion date: July 2025

Study information

• Verified date: August 2023
• Source: London School of Hygiene and Tropical Medicine
• Contact: R Matthew Chico, MPH, PhD
• Phone: +44 2079272841
• Email: matthew.chico[@]lshtm.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Plus Project will assess the impact, operational feasibility, efficacy, effectiveness, and cost-effectiveness of PMC. Specifically, the impact evaluation will involve monitoring a passive cohort of all children in the study area reporting all doses of SP received and the number of confirmed cases of malaria and anaemia, as well as a prospective active cohort of children who will have seven home visits over an 18-month period. The total number of participants is expected to be approximately 2,080 children in the areas served by 35 health centres in Cameroon. The results of this study will allow direct evaluation of the protective efficacy of PMC on malaria incidence, severe anaemia, and malaria mortality.

Description:

Despite impressive progress in recent years, malaria continues to impose a heavy morbidity and mortality burden. Ninety-five percent of the estimated 247 million malaria cases and 619,000 deaths worldwide in 2021 occurred in the World Health Organization (WHO) Africa Region [1]. The expansion of SP-IPTi to include children up to two years of age and additional entry points, referred to now as PMC, offers the potential to increase the impact of the intervention by delivering more protective doses of SP to an age group with a higher malaria burden. However, to support the development of national policies and international guidelines on the adoption and implementation of PMC at scale, more evidence is needed on where, when, how and under what circumstances PMC can be effective, cost-effective, acceptable, equitable and feasible.

The aim of the impact evaluation is to inform decision-making by policy makers and programme managers involved in national malaria control programmes by evaluating the protective efficacy of PMC with eight doses versus five doses as standard of care in Cameroon. The design is a multi-site quantitative study of the implementation of PMC in Cameroon. The health districts of Soa and Mbankomo were identified as the intervention and control districts, respectively, based on population size, number of Extended Programme of Immunisation (EPI) facilities, malaria incidence, EPI coverage and availability of an appropriate control population receiving standard care.

All children up to 36 months of age with parental consent will be recruited into a passive cohort. The investigators will also extract data on malaria and anaemia cases among children receiving PMC from health facility records.

The investigators will form and follow an active arm of the cohort in which a randomly selected subset of children in the passive cohort will be visited every three months during the study period in their homes to obtain detailed information, including details of the household, malaria risk factors, history of malaria and anaemia, health-seeking behaviour, and past EPI vaccinations. Blood will be collected for microscopy measures of parasitaemia, anaemia diagnosis by haemoglobin levels, and retrospective analysis of malaria infection (not for clinical management) by polymerase chain reaction methods. Rapid diagnostic tests will be used amongst symptomatic children to identify cases. First line antimalarial treatment will be provided to all confirmed cases. Children will be screened for malnutrition by measuring their mid-upper arm circumference (MUAC). If they are determined to have either moderate (MAM) or severe acute malnutrition (SAM), treatment will consist of standard of care which can include referral to the nearest health facility with clinical management capacity or treatment on site.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2080
• Est. completion date: July 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 9 Months

Eligibility

Inclusion Criteria:

• Reside in Soa (intervention) or Mbankomo (control) health districts.

• Agree to take part in the census.

• Aged 6-9 months at the time of enrolment.

Exclusion Criteria:

• Parent/caregiver refused to participate in the cohort.

• Parent/caregiver did not give informed consent.

Related Conditions & MeSH terms

• Anemia
• Malaria

Intervention

Drug:
• Sulfadoxine pyrimethamine
Sulfadoxine-pyrimethamine paediatric formulation (250mg/12.5mg) dispersable tablets (Macleods Pharmaceuticals Ltd)

Locations

Country	Name	City	State
Cameroon	Multiple	Soa/Mbankomo

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Fobang Institutes Centre for Health Implementation and Translational Research

Country where clinical trial is conducted

Cameroon, 

References & Publications (1)

WHO Malaria Report 2022, World Health Organisation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of malaria infection and clinical malaria	Incidence of: (1) malaria infection, and (2) clinical malaria in children residing in areas designated to receive PMC (intervention) versus standard care (control).	18 months
Secondary	Incidence of severe malaria, malaria deaths, anaemia and severe anaemia	Incidence of: (1) severe malaria, (2) malaria deaths, (3) anaemia, and (4) severe anaemia in children residing in areas designated to receive PMC (intervention) versus standard care (control).	18 months
Secondary	Malaria and anaemia incidence by delivery platform, number of doses and dose schedule	Measure differences in incidence between children residing in areas designated to receive PMC (intervention) versus standard of care (control) based on differences in SP dose patterns by delivery platform, number of doses of SP, and the SP dose schedule.	18 months
Secondary	Dose-response effects of SP on malaria and anaemia	Measure the dose-response effects of SP on incidence of: (1) malaria infection, (2) clinical malaria, (3) severe malaria, (4) anaemia, (5) severe anaemia, and (6) malaria mortality throughout the period of observation.	18 months
Secondary	Effects of distance to health facility on malaria and anaemia	Measure the effects of distance to health facility on incidence of: (1) malaria infection, (2) clinical malaria, (3) severe malaria, (4) anaemia, (5) severe anaemia, and (6) malaria mortality throughout the period of observation.	18 months
Secondary	Incidence of moderate, severe and overall malnutrition	Incidence of: (1) moderate, (2) severe, and (3) overall malnutrition among children residing in areas designated to receive PMC (intervention) versus standard care (control).	12 months