IGHID 12334 - After the Flood: Optimal Strategies to Prevent Malaria Epidemics Caused by Severe Flooding

Summary

The purpose of this study is to test different ways to prevent malaria infections after flooding. To accomplish this, the investigators will assign villages to different control strategies and measure the number of malaria infections in each of the villages. Residents of all villages will receive new bed nets, but in some villages, residents will be provided with a monthly medication Dihydroartemisinin-piperaquine (DP) (a drug that is approved by the World Health Organization (WHO) and regulatory authorities and widely used in Africa for Malaria treatment. This drug is not approved by Food and Drug Administration (FDA) because it is not used in the US,) to prevent malaria, while others will also receive a treatment that can be placed into pools of water around the home to prevent mosquitoes from breeding there. The investigators will monitor the participant and their household members for mosquitoes and malaria over a period of 12 months after the flooding This study is important because, similar approaches could be used to prevent malaria after floods, which is occurring more frequently.

Conditions

• Malaria Infection
• Malaria Falciparum

Interventions

DRUG

Dihydroartemisinin piperaquine

Taken orally. 11 kg to less than 17 kg 1 tablet per day for 3 days 40 mg 320 mg 17 kg to less than 25 kg 1½ tablets per day for 3 days 60 mg 480 mg 25 kg to less than 36 kg 2 tablets per day for 3 days 80 mg 640 mg 36 kg to less than 60 kg 3 tablets per day for 3 days 120 mg 960 mg 60 kg to less than 80 kg 4 tablets per day for 3 days 160 mg 1280 mg 80 kg or more 5 tablets per day for 3 days 200 mg 1600 mg For patients weighing less than 11 kg, alternative formulations supplying lower amounts of active substance should be preferred

COMBINATION_PRODUCT

Dihydroartemisinin piperaquine + Bacillus thuringiensis israelensis

Study staff will provide adult participant with LLIN(s), DP and with an 8-oz packet of Bti, a pair of latex gloves, a teaspoon, and a tracking form. A staff member will then survey an area (50 m radius) around the house and demonstrate appropriate application in up to 5 potential breeding sites.

OTHER

Long-lasting Insecticidal Net

Distribution of Long-lasting Insecticidal Net to all households on the study.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• North Carolina State University

  collaborator OTHER

• Mbarara University of Science and Technology

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Ross Boyce, MD, M.Sc. · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-03-12

Primary Completion

2026-07-01

Completion

2026-07-01

Countries

• Uganda

Study Locations