Clinical trial NCT05980156: Comparing Chemoprevention Drugs for School-based Malaria Control
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria,Falciparum
Anemia in Children
Keywords: malaria
school
chemoprevention
preventive treatment
education
cognitive function
adolescent
hemoglobin
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Kamuzu University of Health Sciences
name: Doris Duke Charitable Foundation
First posted: 2023-08-07
Enrollment: 646
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with P. falciparum infection
timeFrame: 6-8 weeks after the last intervention
Secondary outcomes:
measure: Number of participants with anemia
timeFrame: 6-8 weeks after the last intervention
measure: Mean hemoglobin concentration
timeFrame: 6-8 weeks after the last intervention
measure: Total parasite density
timeFrame: 6-8 weeks after the last intervention
measure: Rate of clinical malaria
timeFrame: through study completions, approximately 6 months
measure: P. falciparum prevalence among children less than 5 years old living in households with study participants
timeFrame: 6-8 weeks after the last intervention
measure: sustained attention
timeFrame: 6-8 weeks after the last intervention
measure: selective attention
timeFrame: 6-8 weeks after the last intervention
measure: Literacy skills
timeFrame: 6-8 weeks after the last intervention
measure: Math skills
timeFrame: 6-8 weeks after the last intervention
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Kamuzu University of Health Sciences
Study officials:
affiliation: University of Maryland, Baltimore
name: Lauren Cohee, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.