- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05856357
Perennial Malaria Chemoprevention (PMC) in Côte d'Ivoire
Impact Evaluation of Intermittent Preventive Treatment of Malaria in Infants Plus (IPTi+) in Côte d'Ivoire: The Plus Project
Study Overview
Status
Intervention / Treatment
Detailed 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 five doses versus zero doses as standard of care in Côte d'Ivoire. The design is a multi-site quantitative study of the implementation of PMC in Côte d'Ivoire. The health districts of Seguela and Kani 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: R Matthew Chico, MPH, PhD
- Phone Number: +44 2079272841
- Email: matthew.chico@lshtm.ac.uk
Study Locations
-
-
-
Séguéla, Côte D'Ivoire
- Recruiting
- Multiple
-
Contact:
- William Yavo, PharmD, Ph
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Reside in Seguela (intervention) or Kani (control) health districts.
- Agree to take part in the census.
- Aged 10 weeks to six months at the time of enrolment.
- Parent/caregiver informed consent obtained.
Exclusion Criteria:
- Parent/caregiver refused to participate in the cohort.
- Parent/caregiver did not give informed consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Active cohort control
Children (aged 10 weeks to 6 months) in the control arm will receive the standard of care: 0 doses of SP.
|
|
Active cohort intervention
Children (aged 10 weeks to 6 months) in the intervention arm with receive PMC: five doses of SP at EPI visits (10 weeks, 14 weeks, 9 months, 15 months, 18 months)
|
Sulfadoxine-pyrimethamine paediatric formulation (250mg/12.5mg)
dispersable tablets (Macleods Pharmaceuticals Ltd)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of malaria infection and clinical malaria
Time Frame: 18 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of severe malaria, malaria deaths, anaemia and severe anaemia
Time Frame: 18 months
|
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
|
Malaria and anaemia incidence by delivery platform, number of doses and dose schedule
Time Frame: 18 months
|
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
|
Dose-response effects of SP on malaria and anaemia
Time Frame: 18 months
|
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
|
Effects of distance to health facility on malaria and anaemia
Time Frame: 18 months
|
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
|
Incidence of moderate, severe and overall malnutrition
Time Frame: 12 months
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: William Yavo, PharmD, PhD, Institut National de Santé Publique de Côte d'Ivoire
- Principal Investigator: R Matthew Chico, MPH, PhD, London School of Hygiene and Tropical Medicine
Publications and helpful links
General Publications
- WHO Malaria Report 2022, World Health Organisation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Folic Acid Antagonists
- Anti-Infective Agents, Urinary
- Pyrimethamine
- Sulfadoxine
- Fanasil, pyrimethamine drug combination
Other Study ID Numbers
- PLUS-27988-CDI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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