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Completed

NCT Number: NCT06083688

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

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.

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Key information

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Malaria Alert Centre

Blantyre, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Dihydroartemisinin-Piperaquine

Drug

Treatment will be with DP (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older).

Other names: DP, D-Artepp, DuoCotecxin, Artekin, Eurartesim, Ridmal

Chloroquine

Drug

Treatment will be with CQ alone if female and 13 years old or older in both intervention arms.

Other names: Aralen, Hydroxychloroquine, Lariago

Sulfadoxine-pyrimethamine-amodiaquine

Drug

Treatment in Arm 2 (females less than 13 years old and all males).

Other names: SPAQ, SPAQ-Co

Primary outcomes

  1. Number of participants with P. falciparum infection

    Time frame: 6-8 weeks after the last intervention

    detected by polymerase chain reaction (PCR, binary)

  2. Number of participants with anemia

    Time frame: 6-8 weeks after the last intervention

    World Health Organization age-sex definitions (binary)

  3. Rate of clinical malaria

    Time frame: through study completion (approximately 6 months), and 6 months following the intervention

    cumulative incidence

Secondary outcomes

  1. Mean hemoglobin concentration

    Time frame: 6-8 weeks after the last intervention

    g/dL (continuous)

  2. Literacy skills

    Time frame: 6-8 weeks after the last intervention

    Early grade reading assessment

  3. Math skills

    Time frame: 6-8 weeks after the last intervention

    Early grade math assessment

  4. Rate of school absenteeism among participants

    Time frame: through study completion (approximately 6 months)

    Proportion of days absent among days where attendance is assessed

  5. P. falciparum prevalence among children less than 5 years old living in households with study participants

    Time frame: 6-8 weeks after the last intervention

    detected by PCR

  6. Rate of clinical malaria among children less than 5 years old living in households with study participants

    Time frame: through study completion (approximately 6 months)

    cumulative incidence

Other outcomes

  1. Total parasite density

    Time frame: 6-8 weeks after the last intervention

    log transformed (continuous)

Sponsors and collaborators

Lead sponsor

Liverpool School of Tropical Medicine

Other

Collaborators

  • Kamuzu University of Health Sciences

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 16, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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