Community-led Responses for Elimination: Controlled Trial of Reactive Case Detection Versus Reactive Drug Administration

Malaria Clinical Trial

— CORE Zambia  

Official title:

Community-led Responses for Elimination (CoRE): A Cluster Randomized Controlled Trial of Reactive Case Detection Versus Reactive Drug Administration in Malaria Elimination Areas in Southern Province Zambia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654912
• Other study ID #: PATH-WIRB-1155095
• Status: Completed
• Phase: Phase 4
• Start date: February 2016
• Est. completion date: July 2020

Study information

• Verified date: September 2020
• Source: PATH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to compare the effectiveness of reactive focal drug administration (RFDA) using dihydroartemisinin+piperaquine (DHAP) versus reactive focal test and treat (RFTAT) using artemether+lumefantrine (AL) as a routine process for identifying and eliminating malaria transmission as measured through achieving zero seropositivity in children under five in Southern Province, Zambia. These two strategies are potential candidates for expanded malaria operational surveillance and elimination for low malaria transmission areas.

Description:

The study is a cluster randomized controlled trial designed to evaluate the impact of RFDA intervention against current standard of care for the impact on seropositivity in children under five years, passive surveillance for confirmed malaria case incidence, and elimination of transmission from hotspots. It will be conducted among a background population of ~130,000 people in ~30,000 households in 16 health center catchment areas across several districts in Southern Province. The government of Zambia is pursuing malaria elimination as a national goal on an accelerated timeline and this trial will help evaluate two treatment-based strategies for supporting malaria elimination.

The secondary objectives of the study include: 1). Compare the effectiveness of RFDA using DHAP with RFTAT using AL in reducing rapid diagnostic test (RDT) confirmed malaria incidence through passive case detection at health facilities; 2). Compare the effectiveness of RFDA using DHAP with RFTAT using AL in reducing the prevalence of malaria and preventing re-infection in individuals receiving reactive responses; 3). Compare the cost-effectiveness of RFDA using DHAP with RFTAT using AL in reducing the burden of malaria in the community; 4). Measure the proportion of P. falciparum infections likely attributable to importation and local transmission using parasite genotyping as well as defining genotype spatial distribution; 5). Assess the utility of using serology to measure short term changes in malaria transmission and evaluate malaria elimination programs; and 6). Assess the feasibility of using remotely sensed malaria risk maps to identify areas with higher potential for local malaria transmission.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8682
• Est. completion date: July 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months and older

Eligibility

Inclusion Criteria:

• anyone not excluded and consenting

Exclusion Criteria:

• contraindications from manufacturer for medications including currently taking haloperidol, artane, Phenergan (Promethazine), chlorpromazine, erythromycin, Azithromycin, clarithromycin, Ketoconazole, fluconazole, mefloquine (as prophylaxis), lumefantrine (in Coartem), quinine, Septrin

• anyone seriously ill

• currently taking antimalarial medicines

• allergy to artemisinin drugs

• pregnant women in first trimester

• children under 3 months of age

• reported heart condition

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Reactive Focal Drug Administration
This is the experimental arm and is described by a reactive response to passively detected index case of malaria. The reactive response consists of treating all individuals within a defined radius of each RDT-confirmed incident malaria case with dihydroartemisinin-piperaquine (DHAP).

Locations

Country	Name	City	State
Zambia	Southern province medical office	Choma	Southern

Sponsors (3)

Lead Sponsor	Collaborator
PATH	AKROS Global Health, Ministry of Health, Zambia

Country where clinical trial is conducted

Zambia, 

References & Publications (1)

Bridges DJ, Miller JM, Chalwe V, Moonga H, Hamainza B, Steketee R, Silumbe K, Nyangu J, Larsen DA. Community-led Responses for Elimination (CoRE): a study protocol for a community randomized controlled trial assessing the effectiveness of community-level, reactive focal drug administration for reducing Plasmodium falciparum infection prevalence and incidence in Southern Province, Zambia. Trials. 2017 Nov 2;18(1):511. doi: 10.1186/s13063-017-2249-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malaria seropositivity in children under five	Malaria seropositivity in children under five after two-year intervention within health center catchment areas	24 months
Secondary	Incidence of malaria confirmed by RDT or microscopy as measured through passive case detection at health posts and health centers	Quality-improved incidence of malaria data confirmed by malaria rapid diagnostic test (RDT) or microscopy as measured through passive case detection at health posts and health centers in the study area.	24 months
Secondary	PCR parasite prevalence among individuals participating at 0, 30 and 90 days following a reactive research response for a period of 24 months	Polymerase Chain Reaction (PCR)-based testing for malaria parasite prevalence of individuals participating in each community at 0, 30 and 90 days following a reactive research response for a period of 24 months	24 months