Comparing Chemoprevention Drugs for School-based Malaria Control

Malaria,Falciparum Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05980156
• Other study ID #: HP-00098250v3
• Status: Completed
• Phase: Phase 4
• Start date: February 13, 2023
• Est. completion date: July 28, 2023

Study information

• Verified date: August 2023
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 646
• Est. completion date: July 28, 2023
• Est. primary completion date: July 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia in Children
• Malaria
• Malaria, Falciparum
• Malaria,Falciparum

Intervention

Drug:
• Dihydroartemisinin-Piperaquine
Treatment will be with DP (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).
• Chloroquine
Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2.
• Sulfadoxine pyrimethamine
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).

Locations

Country	Name	City	State
Malawi	Kamuzu University of Health Sciences	Blantyre

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Doris Duke Charitable Foundation, Kamuzu University of Health Sciences

Country where clinical trial is conducted

Malawi, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with P. falciparum infection	detected by polymerase chain reaction (PCR, binary)	6-8 weeks after the last intervention
Secondary	Number of participants with anemia	World Health Organization age-sex definitions (binary)	6-8 weeks after the last intervention
Secondary	Mean hemoglobin concentration	g/dL (continuous)	6-8 weeks after the last intervention
Secondary	Total parasite density	log transformed (continuous)	6-8 weeks after the last intervention
Secondary	Rate of clinical malaria	cumulative incidence	through study completions, approximately 6 months
Secondary	P. falciparum prevalence among children less than 5 years old living in households with study participants	detected by PCR	6-8 weeks after the last intervention
Secondary	sustained attention	code transmission test score (continuous)	6-8 weeks after the last intervention
Secondary	selective attention	selective attention test score (continuous)	6-8 weeks after the last intervention
Secondary	Literacy skills	onetest reading test score (continuous)	6-8 weeks after the last intervention
Secondary	Math skills	onetest math score (continuous)	6-8 weeks after the last intervention