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Parasite Clearance and Protection From Infection (PCPI) in Zambia

NCT06166498 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-03-12

No results posted yet for this study

Summary

The Zambia PCPI study will measure the effect of the parasite genotypes associated with SP resistance on parasite clearance and protection from infection when exposed to SP. The total number of participants is expected to be 600 healthy between 3 to 5 years old who have no symptoms of malaria infection of which 400 children will be assigned to the SP group and 200 to the AS group. The results of this study will allow to measure the effect of the parasite genotypes associated with SP resistance on parasite clearance and protection from infection when exposed to SP.

Conditions

Interventions

DRUG

SP (Macleods Pharmaceuticals Ltd)

Children who weigh \<10kg will receive Sulfadoxine-pyrimethamine paediatric formulation (250mg/12.5mg) dispersable tablets; children who weigh \>10kg will receive 500mg sulfadoxine plus 25mg pyrimethamine

DRUG

AS (Guilin Pharmaceuticals)

Children will receive 4 mg/kg/day for 7 days

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • R Matthew Chico, MPH, PhD · London School of Hygiene and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-24
Primary Completion
2024-12-19
Completion
2025-03-05

Countries

  • Zambia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06166498 on ClinicalTrials.gov