Plasmodium Falciparum Malaria Clinical Trial
— COMBATOfficial title:
Targeting High-risk Populations With Enhanced Reactive Case Detection: a Study to Assess the Effectiveness and Feasibility for Reducing Plasmodium Falciparum and P. Vivax Malaria in Southern Lao Peoples Democratic Republic
This study assesses the effectiveness and feasibility of enhanced reactive case detection (RACD) targeting high-risk villages and forest workers for reducing Plasmodium falciparum and Plasmodium vivax transmission in southern Lao Peoples Democratic Republic. The authors hypothesize that enhanced community-based RACD will be more effective than standard of care case management and RACD at reducing P. falciparum and P. vivax confirmed case incidence and parasite prevalence over an 18-month period in Lao Peoples Democratic Republic.
Status | Recruiting |
Enrollment | 31443 |
Est. completion date | November 1, 2021 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Months and older |
Eligibility | RACD: - Inclusion Criteria - Inclusion Criteria for index cases: Presented as a confirmed malaria case to an intervention health facility or village malaria worker, and lives in a village within a selected intervention health facility catchment area, or worked or spent at least one night at a forest or forest-fringe site in the past 30 days located within an intervention health facility catchment area - Inclusion criteria for village residents: Lives in a village within a selected intervention health facility catchment area and in one of the five households closest to the residence of an index case of malaria - Inclusion criteria for co-worker/traveler referral: Worked or traveled and spent at least one night in forest in past 30 days in same location within an intervention health facility catchment area as an index case of malaria - Inclusion criteria for all participants: Willing and available to participate in the study Informed consent for participant under the age of 18 will be provided by the parent or guardian. - Exclusion Criteria: - Previous participation in the study as a result of any RACD event in the past 30 days. - Individuals with suspected severe malaria or other severe illness (including those with symptoms of severe anemia, prostration, impaired consciousness, respiratory distress, convulsions, circulatory collapse, abnormal bleeding, jaundice or passing dark urine) will be excluded from the treatment component and referred to the nearest health facility for clinical assessment and treatment |
Country | Name | City | State |
---|---|---|---|
Lao People's Democratic Republic | Center for Malariology, Parasitology, Entomology, Laos Ministry of Health | Vientiane |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Center for Malariology, Parasitology, and Entomology, Centers for Disease Control and Prevention, Tulane University School of Public Health and Tropical Medicine, University of Massachusetts, Amherst |
Lao People's Democratic Republic,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Confirmed P. falciparum and P. vivax malaria parasite incidence | This is defined as the number of outpatient (OPD) malaria confirmed and suspected cases per person per year for each Health Center Catchment Area (HCCA), as ascertained from the health facility registers, utilizing administrative catchment population size estimates for the exposure denominator. | 4 months | |
Primary | PCR-based P. falciparum and P. vivax parasite prevalence in sampled HCCAs | This is defined as the proportion of individuals =18 months old with P. falciparum or P. vivax infection (detected by PCR) out of all individuals =18 months tested within the end line survey (2020). | 4 months | |
Primary | HS-RDT/RDT-based test positivity rate in village and forest-based reactive case detection | This is defined as the proportion of all individuals tested by HS-RDT/RDT in response to an index cases, with a positive HS-RDT/RDT, among the population older than 18 months. | 4 months |
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