Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi

Last updated: November 18, 2025
Sponsor: Liverpool School of Tropical Medicine
Overall Status: Active - Not Recruiting

Phase

4

Condition

N/A

Treatment

Sulfadoxine pyrimethamine

Chloroquine

Dihydroartemisinin-Piperaquine

Clinical Study ID

NCT06083688
23-048
  • Ages > 6
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ) (IPT-SPAQ). Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, anemia, cognitive function and educational testing, as well as infection prevalence and disease incidence in young children sleeping student's households to assess the impact on transmission.

Eligibility Criteria

Inclusion

Student Inclusion Criteria:

  • Currently enrolled in the study school

  • Plan to attend the study school for the remainder of the school year

  • Parent/guardian available to provide written informed consent

Exclusion

Student Exclusion Criteria:

  • Current evidence of severe malaria or danger signs

  • Known adverse reaction to the study drugs

  • History of cardiac problems or fainting

  • Taking medications known to prolong QT

  • Family history of prolonged QT

  • History of epilepsy or psoriasis

  • Taking cotrimoxazole for long-term prophylaxis

Younger child Inclusion Criteria

  • Slept in the household for most nights in the last month

  • Age 6-59 months

  • Parent/guardian available to provide written informed consent

Younger child Exclusion Criteria

  • Current evidence of severe malaria or danger signs

Study Design

Total Participants: 1000
Treatment Group(s): 4
Primary Treatment: Sulfadoxine pyrimethamine
Phase: 4
Study Start date:
October 14, 2024
Estimated Completion Date:
January 31, 2026

Study Description

Students attending primary school in rural Blantyre District, Malawi will be offered enrollment in this study. The intervention will be conducted every 6-weeks during the school terms which coincide with peak malaria transmission. Students in the IPT-DP arm will be treated with with dihydroartemisinin-piperaquine (DP) (females less than 13 years old and all males) or chloroquine (females 13 years old or older). Students in the IPT-SPAQ arm will be treated with sulfadoxine-pyrimethamine plus amodiaquine (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older). Students in the all arms will receive routine malaria education.

Connect with a study center

  • Malaria Alert Centre

    Blantyre,
    Malawi

    Site Not Available

  • Malaria Alert Centre

    Blantyre 931755,
    Malawi

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.