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Completed

NCT Number: NCT05980156

Comparing Chemoprevention Drugs for School-based Malaria Control

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 chloroquine (CQ) (IPT-SPCQ). 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 in young children sleeping student's households to assess the impact on transmission.

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Key information

Conditions

Malaria,Falciparum Anemia in Children Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kamuzu University of Health Sciences

Blantyre, Malawi

About this study

Students attending a single primary school in Machinga District, Malawi who were enrolled in NCT05244954 were offered enrollment in this follow-on study. The intervention will be conducted every 6-weeks during the two 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 10 years old and all males) or chloroquine (females 10 years old or older. Students in the IPT-SPCQ arm will be treated with sulfadoxine-pyrimethamine plus chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Students (enrolled in the primary intervention)

  • Previously enrolled in NCT05244954
  • 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 Younger children in participant households (enrolled in the Household Prevalence survey)
  • Slept in the household for most nights in the last month
  • Age 6-59 months
  • Parent/guardian available to provide written informed consent

Exclusion criteria

Students (enrolled in the primary intervention)

  • 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
  • Taking trimethoprim-sulfamethoxazole aka Bactrim or Cotrimoxazole
  • Epilepsy
  • Psoriasis Household members (enrolled in the Household Prevalence survey)
  • Household with more than one school-age child enrolled in the study
  • Current evidence of severe malaria or danger signs

Treatment and study plan

Dihydroartemisinin-Piperaquine

Drug

Treatment will be with DP (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).

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

Chloroquine

Drug

Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2.

Other names: Aralen, Hydroxychloroquine, Lariago

Sulfadoxine pyrimethamine

Drug

Treatment will be with SP and chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).

Other names: SP

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)

Secondary outcomes

  1. Number of participants with anemia

    Time frame: 6-8 weeks after the last intervention

    World Health Organization age-sex definitions (binary)

  2. Mean hemoglobin concentration

    Time frame: 6-8 weeks after the last intervention

    g/dL (continuous)

  3. Total parasite density

    Time frame: 6-8 weeks after the last intervention

    log transformed (continuous)

  4. Rate of clinical malaria

    Time frame: through study completions, approximately 6 months

    cumulative incidence

  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. sustained attention

    Time frame: 6-8 weeks after the last intervention

    code transmission test score (continuous)

  7. selective attention

    Time frame: 6-8 weeks after the last intervention

    selective attention test score (continuous)

  8. Literacy skills

    Time frame: 6-8 weeks after the last intervention

    onetest reading test score (continuous)

  9. Math skills

    Time frame: 6-8 weeks after the last intervention

    onetest math score (continuous)

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Doris Duke Charitable Foundation
  • Kamuzu University of Health Sciences

Registry information

Official study title

Clinical Trial to Evaluate Intermittent Screening and Treatment and Intermittent Preventive Treatment of Malaria in Asymptomatic Schoolchildren to Decrease P. Falciparum Infection and Transmission: Phase 2 Comparing Drug Regimens

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 7, 2023
Registry last updated
Aug 7, 2023

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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