Comparing Chemoprevention Drugs for School-based Malaria Control

NCT05980156 | Completed Phase 4 DMC

• 1 other identifier: HP-00098250v3
• Study Type: interventional
• Target: 646
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Malaria,Falciparum; Anemia in Children

Keywords

malaria; school; chemoprevention; preventive treatment; education; cognitive function; adolescent; hemoglobin

Outcome Measures

Primary Outcomes (1)

• Number of participants with P. falciparum infection

  detected by polymerase chain reaction (PCR, binary)

  6-8 weeks after the last intervention

Secondary Outcomes (9)

• Number of participants with anemia

  6-8 weeks after the last intervention

• Mean hemoglobin concentration

  6-8 weeks after the last intervention

• Total parasite density

  6-8 weeks after the last intervention

• Rate of clinical malaria

  through study completions, approximately 6 months

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

  6-8 weeks after the last intervention

Study Arms (3)

Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)

EXPERIMENTAL

All students are treated at each intervention. Treatment will be with DP (females less than 10 years old and all males) or chloroquine (females 10 years old or older).

Drug: Dihydroartemisinin-Piperaquine; Drug: Chloroquine

Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)

EXPERIMENTAL

All students are treated at each intervention. Treatment will be with SP + CQ (females less than 10 years old and all males) or chloroquine (females 10 years old or older).

Drug: Chloroquine; Drug: Sulfadoxine pyrimethamine

Control

NO INTERVENTION

Students will not receive preventive treatment.

Interventions

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).

Also known as: DP, D-Artepp, DuoCotecxin, Artekin, Eurartesim, Ridmal

Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)

Chloroquine DRUG

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

Also known as: Aralen, Hydroxychloroquine, Lariago

Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP); Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)

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).

Also known as: SP

Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Kamuzu University of Health Sciences: collaborator
• Doris Duke Charitable Foundation: collaborator

Study Sites (1)

Kamuzu University of Health Sciences

Blantyre, Malawi

Location

Related Publications (2)

• Cohee LM, Valim C, Coalson JE, Nyambalo A, Chilombe M, Ngwira A, Bauleni A, Seydel KB, Wilson ML, Taylor TE, Mathanga DP, Laufer MK. School-based screening and treatment may reduce P. falciparum transmission. Sci Rep. 2021 Mar 25;11(1):6905. doi: 10.1038/s41598-021-86450-5.

  PMID: 33767384 BACKGROUND

• Cohee LM, Opondo C, Clarke SE, Halliday KE, Cano J, Shipper AG, Barger-Kamate B, Djimde A, Diarra S, Dokras A, Kamya MR, Lutumba P, Ly AB, Nankabirwa JI, Njagi JK, Maiga H, Maiteki-Sebuguzi C, Matangila J, Okello G, Rohner F, Roschnik N, Rouhani S, Sissoko MS, Staedke SG, Thera MA, Turner EL, Van Geertruyden JP, Zimmerman MB, Jukes MCH, Brooker SJ, Allen E, Laufer MK, Chico RM. Preventive malaria treatment among school-aged children in sub-Saharan Africa: a systematic review and meta-analyses. Lancet Glob Health. 2020 Dec;8(12):e1499-e1511. doi: 10.1016/S2214-109X(20)30325-9. Epub 2020 Oct 22.

  PMID: 33222799 BACKGROUND

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Interventions

Chloroquine; Hydroxychloroquine; fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lauren Cohee, MD MS

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory technicians processing samples will be blinded to participant's study arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: Students were randomized to three arms in the original trial. In this follow-on study, students will remain in their study arms. Arm 1 which previously received intermittent screening-and-treatment will now receive intermittent preventive treatment with sulfadoxine-pyrimethamine plus chloroquine. Arm 2 which received intermittent preventive treatment with dihydroartemisinin-piperaquine will again receive intermittent preventive treatment with dihydroartemisinin-piperaquine. Arm 3 the control arm will continue as a control. Females 10 years and older (potentially post-menarche) in Arms 1 and 2 will receive chloroquine alone.

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 7, 2023
• Study Start: February 13, 2023
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After results publication
• Access Criteria: Public access with registration to allow tracking

Locations

MA (1)