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

Malaria,Falciparum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06083688
• Other study ID #: 23-048
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 2024
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Liverpool School of Tropical Medicine
• Contact: Lauren M Cohee, MD MS
• Phone: 00441513517674
• Email: lauren.cohee[@]lstmed.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an individually randomized, controlled, single blind four 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: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ) (IPT-SPAQ).Arm 4: 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.

Description:

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 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 13 years old and all males) or chloroquine (females 13 years old or older). Students in the IPT-SPCQ arm will be treated with sulfadoxine-pyrimethamine plus chloroquine (females less than 13 years old and all males) or chloroquine alone (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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Dihydroartemisinin-Piperaquine
Treatment will be with DP (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older).
• Chloroquine
Treatment will be with CQ alone if female and 13 years old or older in all study arms. Treatment in combination with SP in Arm 2 (females less than 13 years old and all males).
• Sulfadoxine pyrimethamine
Treatment in combination with CQ in Arm 2 (females less than 13 years old and all males). Treatment in combination with AQ in Arm 3 (females less than 13 years old and all males).
• Sulfadoxine-pyrimethamine-amodiaquine
Treatment in Arm 3 (females less than 13 years old and all males).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Liverpool School of Tropical Medicine	Kamuzu University of Health Sciences

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 completion (approximately 6 months), and 6 months following the intervention
Secondary	sustained attention	code transmission test score (continuous)	6-8 weeks after the last intervention
Secondary	Literacy skills	Early grade reading assessment	6-8 weeks after the last intervention
Secondary	Math skills	Early grade math assessment	6-8 weeks after the last intervention
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	Rate of clinical malaria among children less than 5 years old living in households with study participants	cumulative incidence	through study completion (approximately 6 months)