NCT05856357

Brief 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 1568 children in the areas served by 19 health centres in Côte d'Ivoire. The results of this study will allow direct evaluation of the protective efficacy of PMC on malaria incidence, severe anaemia, and malaria mortality.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,568

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

August 11, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

January 9, 2025

Status Verified

October 1, 2024

Enrollment Period

1.8 years

First QC Date

May 3, 2023

Last Update Submit

January 8, 2025

Conditions

MalariaAnemia

Keywords

MalariaAnemiaPerennial malaria chemoprevention (PMC)Intermittent preventative treatment of infants (IPTi)Sulfadoxine-pyrimethamine (SP)Chemoprevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Incidence of severe malaria, malaria deaths, anaemia and severe anaemia

    18 months

  • Malaria and anaemia incidence by delivery platform, number of doses and dose schedule

    18 months

  • Dose-response effects of SP on malaria and anaemia

    18 months

  • Effects of distance to health facility on malaria and anaemia

    18 months

  • Incidence of moderate, severe and overall malnutrition

    12 months

Study Arms (2)

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)

Drug: Sulfadoxine pyrimethamine

Interventions

Sulfadoxine pyrimethamineDRUG

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

Active cohort intervention

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children up to 6 months of age in Seguela and Kani health districts of Côte d'Ivoire.

You may qualify if:

  • 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.

You may not qualify if:

  • Parent/caregiver refused to participate in the cohort.
  • Parent/caregiver did not give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple

Séguéla, Côte d’Ivoire

Location

Related Publications (2)

  • WHO Malaria Report 2022, World Health Organisation

    BACKGROUND

  • Stresman G, Lal S, Bruce J, Nji A, Serge-Brice A, Mosoff J, McGirr A, Gore-Langton G, McGuire M, Sinsai J, Lele A, Tah-Monunde M, Kouadio ZB, Anatole M, Konate-Toure A, Clarke SE, Gosling R, Mbacham WF, Yavo W, Chico RM. Effectiveness of malaria chemoprevention in the first two years of life in Cameroon and Cote d'Ivoire compared to standard of care: study protocol for a population-based prospective cohort impact evaluation study. BMC Public Health. 2024 Sep 6;24(1):2430. doi: 10.1186/s12889-024-19887-8.

    PMID: 39243075DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Dried blood spots

MeSH Terms

Conditions

MalariaAnemia

Interventions

fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2023

First Posted

May 12, 2023

Study Start

August 11, 2023

Primary Completion

June 1, 2025

Study Completion

September 1, 2025

Last Updated

January 9, 2025

Record last verified: 2024-10

Locations

CÔ(1)