Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Focal Mass Drug Administration (fMDA)
Focal Mass Drug Administration · 1 trial · 2 indications
Number of microscopy-confirmed, Plasmodium vivax malaria cases in residents reported from health facilities per population over the 36-month follow-up study period
| Arm | Type | Description |
|---|---|---|
| Control: Standard Interventions | NO_INTERVENTION | Standard interventions for the control cluster will include providing participants with long-lasting insecticide-treated bednets, management of known and possible mosquito breeding sites, passive case detection through detection and diagnosis of symptomatic cases of malaria in health facilities and through community health workers (conducted in villagers with fever), microscopy testing in households of recent index cases to detect asymptomatic malaria cases, and treatment of active cases of malaria (artesunate-mefloquine (AS-MQ) for Plasmodium falciparum and Chloroquine (CQ) (10 mg/kg on days 1 and 2, followed by 5 mg/kg on day 3) + PQ (0.5mg/kg x 7 days). |
| Focal Mass Drug Administration (fMDA) | EXPERIMENTAL | Standard interventions in addition to focal mass drug administration. Focal mass drug administration will include using primaquine, chloroquine, and tafenoquine, for high-risk individuals residing in households that are within 200 meters of a Plasmodium vivax (Pv) index case households from the prior 2 years (including individuals in the index case household). Pv index cases include symptomatic cases detected at health facilities or in fever screenings, and asymptomatic cases identified during routine active case detection by health facilities. Households will then be notified regarding their potential to receive two rounds fMDA that cycle. Eligibility to receive medications as part of fMDA will be assessed prior to each administration and include glucose 6 phosphate dehydrogenase (G6PD) testing and counseling if not previously conducted or result is not available on the participant's identification card. |
| Name | Type | Description |
|---|---|---|
| Focal Mass Drug Administration (fMDA) | DRUG | Administration of focal mass drug administration for high-risk individuals residing in households that are within 200 meters of a Plasmodium vivax index case households from the prior 2 years (including individuals in the index case household). Intervention to be administered two times, two months apart each cycle, for 3 cycles spaced apart by regular intervals. Each year will include 2 rounds of fMDA. Round 1) Chloroquine (CQ)+ Tafenoquine (TQ) for \>= 16y (CQ: Day1 600 mg, Day 2 600 mg, Day 3 300 mg CQ, TQ 300 mg on Day 1); CQ+ Primaquine (PQ) for \<16y (CQ: age-based dosing, PQ age-based dosing); CQ+PQ for G6PD intermediate individuals \>=6mo and \<16y ((CQ: Day1 600 mg, Day 2 600 mg, Day 3 300 mg, PQ age-based dosing). Round 2) single dose CQ+TQ for \>= 16y (CQ: Day1 600 mg, TQ 300 mg on Day 1); single dose CQ+PQ for \<16y (CQ: age-based dosing, PQ age-based dosing); single dose CQ+PQ for G6PD intermediate individuals \>=6mo and \<16y ((CQ: Day1 600 mg, PQ age-based dosing). |
Inclusion Criteria: 1. Cluster eligibility * Within 8 hours transport of Iquitos * Incidence \<250/1000 and \>2 cases year prior to trial * Population size (\<650) 2. Chloroquine (CQ) eligibility * Resides in neighboring household but within 200 m of Pv index case in the past 2 years ...
Focal Mass Drug Administration (fMDA) is used for the elimination of Plasmodium vivax malaria. It is a Phase 3 investigational strategy being studied in Peru, where it is administered to healthy volunteers and individuals in areas affected by malaria to reduce transmission of the parasite.
Focal Mass Drug Administration targets Plasmodium vivax, the parasite that causes vivax malaria. The approach involves mass drug administration in focal areas to clear the parasite from infected individuals and reduce its spread within the community, with the goal of eliminating the disease.
Focal Mass Drug Administration is being developed by GSK plc, a biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting a Phase 3 clinical trial of this drug administration strategy for vivax malaria elimination.
Focal Mass Drug Administration is in Phase 3 clinical development. It is an investigational strategy and has not been approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants to evaluate its effectiveness in eliminating Plasmodium vivax malaria.
Focal Mass Drug Administration is being evaluated in one Phase 3 clinical trial with the identifier NCT05690841, titled 'FocaL Mass Drug Administration for Vivax Malaria Elimination.' This randomized, open-label trial is recruiting 7,530 participants in Peru and is not yet completed.
Yes, Focal Mass Drug Administration is the same as fMDA, which is an abbreviation for the full name. The drug administration strategy is referred to by both names in clinical research and regulatory contexts.