Malaria, Falciparum Clinical Trial
Official title:
A Multi-centre, Open-label Randomised Trial to Assess the Efficacy, Safety and Tolerability of Triple Artemisinin-based Combination Therapies (TACTs) Com-pared to Artemisinin-based Combination Therapies (ACTs) in Uncomplicated Falciparum Malaria and to Map the Geographical Spread of Artemisinin and Partner Drug Resistance
This study is an open-label randomised trial comparing standard ACT treatment with matching
triple artemisinin-based combination therapies (TACTs), evaluating efficacy in safety and
tolerability. The estimated total sample size is 2040 patients from 16 sites in Asia and 1
site in Africa. There are 2 arm study groups that have 2 treatment arms each.
Study group A:
A.1: Artemether-lumefantrine for 3 days. versus: A.2: Artemether-lumefantrine for 3 days plus
Amodiaquine for 3 days.
Study group B:
B.1: Dihydroartemisinin-piperaquine for 3 days. versus: B.2: Dihydroartemisinin-piperaquine
for 3 days plus Mefloquine hydrochloride for 3 days.
Study group C:
C.1: Artesunate-mefloquine for 3 days versus: C.2: Dihydroartemisinin-piperaquine for 3 days
plus Mefloquine hydrochloride for 3 days.
According to the WHO guideline, all patients except for children under the age of 1 year or a
weight below 10 kilograms will also be treated with a single dose of low dose primaquine.
In Laos, Myanmar, Bangladesh, India and DRC, the following two combinations will be used:
1. Artemether-lumefantrine combined with amodiaquine (TACT arm) or
2. Artemether-lumefantrine (ACT arm)
In Myanmar and Vietnam the following two combinations will be used:
1. Dihydroartemisinin-piperaquine combined with mefloquine (TACT arm) or
2. Dihydroartemisinin-piperaquine (ACT arm)
In Cambodia and Thailand the following two combinations will be used:
1. Dihydroartemisinin-piperaquine plus Mefloquine hydrochloride (TACT arm) or
2. Artesunate-mefloquine (ACT arm)
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02329301 -
Mass Drug Administration With Dihydroartemisinin + Piperaquine for Reducing Malaria in Southern Zambia
|
N/A | |
| Recruiting |
NCT01944189 -
Artemether/ Lumefantrine: A Study of the Effect of Local Food on Pharmacokinetics and Population Pharmacokinetics
|
Phase 4 | |
| Completed |
NCT01325974 -
Time to Become Negative of Three Rapid Diagnostic Tests for Malaria
|
N/A | |
| Terminated |
NCT01442168 -
Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria
|
Phase 1/Phase 2 | |
| Completed |
NCT00375128 -
Sporozoite Challenge of Polyprotein Vaccinees
|
Phase 1/Phase 2 | |
| Terminated |
NCT00374205 -
Randomized Trial on Effectiveness of ACTs in Ghana
|
Phase 4 | |
| Completed |
NCT04609098 -
Single Low Dose Tafenoquine to Reduce P. Falciparum Transmission in Mali (NECTAR2)
|
Phase 2 | |
| Completed |
NCT02851108 -
Methylene Blue Against Falciparum Malaria in Burkina Faso
|
Phase 2 | |
| Completed |
NCT02434952 -
Safety and Tolerability of Low Dose Primaquine
|
Phase 4 | |
| Terminated |
NCT02281344 -
MMV390048 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Participants
|
Phase 1 | |
| Completed |
NCT01213966 -
Efficacy, Tolerability, PK of OZ439 in Adults With Acute, Uncomplicated P.Falciparum or Vivax Malaria Mono-infection
|
Phase 2 | |
| Completed |
NCT00479206 -
Artemisinin Resistance in Cambodia
|
N/A | |
| Completed |
NCT00126906 -
Prevention of Malaria During Pregnancy Using Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine: Malawi
|
N/A | |
| Completed |
NCT01019408 -
Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan
|
Phase 4 | |
| Completed |
NCT00529867 -
Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria
|
Phase 4 | |
| Completed |
NCT00137553 -
The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children
|
Phase 4 | |
| Completed |
NCT02637128 -
In Vivo Efficacy of Artemether-Lumefantrine and Artesunate-Amodiaquine for Uncomplicated P. Falciparum Malaria
|
Phase 4 | |
| Completed |
NCT01222962 -
Food Interaction Study on the Pharmacokinetics of Eurartesim™ (DHA and PQP)in Healthy Male Adult Volunteers
|
Phase 1 | |
| Unknown status |
NCT00152204 -
The Community Effectiveness of IPTi in Southern Tanzania
|
Phase 3 | |
| Terminated |
NCT00084240 -
Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia
|
Phase 2/Phase 3 |