Falciparum Malaria Clinical Trial
Official title:
Artemisinin Resistance in Cambodia II
The purpose of this study is to determine the impact of varying doses of artesunate on
treatment outcome and whether higher doses of artesunate can overcome the problem of
compromised artemisinin sensitivity in the region.
To determine the safety and tolerability of this previously untested experimental high dose
(6 mg/Kg/D X 7 day, total 42 mg/Kg) artesunate monotherapy regimen.
A total of 150 volunteers with acute uncomplicated falciparum malaria will be randomly
assigned one of 3 arms to be treated with artesunate monotherapy for 7 days at a ratio of
2:1:2.
Arm 2 serves as a control and will serve as a bridge to the ARC 1 study performed in
2006/2007. Patients in Arm 1 will receive a relatively low "standard" dose, and patients in
Arm 2 will receive the intermediate dose of 4 mg/kg that was used in the ARC1 study.
Patients in Arm 3 will receive an experimental "high-dose" regimen. Currently available
safety data extends to subjects who have received the 28 mg/Kg total dose over 7 days and to
another study administering 8 mg/Kg/day for 3 days (total dose 24 mg/Kg). Subjects
randomized into this study's 'high-dose' Arm 3 will, therefore, receive a total dose that is
higher than has been previously studied in humans.
The study design will be based on the WHO recommendations for the 'Assessment and Monitoring
of Antimalarial Drug Efficacy for the Treatment of Uncomplicated Falciparum Malaria' (WHO,
2003).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00440752 -
The Impact of Artemether-Lumefantrine on Genes Associated With Antimalarial Resistance
|
N/A | |
| Completed |
NCT01144702 -
Effectiveness of the Association Artesunate and Mefloquine in the Treatment of Malaria by Plasmodium Falciparum
|
Phase 2/Phase 3 | |
| Terminated |
NCT00400101 -
Phase Ia Malaria Vaccine Trial of Two Virosome-Formulated Peptides
|
Phase 1 | |
| Completed |
NCT01350856 -
Tracking Resistance to Artemisinin (TRAC)
|
Phase 4 | |
| Completed |
NCT00859807 -
A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects
|
Phase 4 | |
| Completed |
NCT04222088 -
TES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014
|
||
| Completed |
NCT01115439 -
Artesunate+Sulfadoxine-Pyrimethamine for the Treatment of Uncomplicated Falciparum Malaria
|
N/A | |
| Completed |
NCT00282919 -
A Three Day Trial of Azithromycin Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria
|
Phase 2 | |
| Completed |
NCT04422015 -
Biological Mechanisms in Afebrile P. Falciparum Malaria
|
||
| Completed |
NCT00894660 -
A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects
|
Phase 1 | |
| Completed |
NCT00894374 -
Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
|
Phase 1 | |
| Completed |
NCT00493363 -
Clinical Investigation of In-vivo Susceptibility of P.Falciparum to Artesunate in Western Cambodia
|
N/A | |
| Completed |
NCT00158548 -
ACT With Chloroquine, Amodiaquine & Sulphadoxine-pyrimethamine in Pakistan
|
Phase 3 | |
| Withdrawn |
NCT04289558 -
Nitrite Infusion in Children With Malaria
|
Phase 1 | |
| Completed |
NCT01374126 -
Azithromycin Combination Therapy for the Treatment of Severe Malaria
|
Phase 2 | |
| Completed |
NCT00157833 -
A Randomized Trial of Coartemether and Artekin for the Treatment of Uncomplicated Malaria in Papua, Indonesia.
|
N/A | |
| Completed |
NCT00513669 -
Phase Ib Trial of Two Virosome Formulated Malaria Vaccine Components (PEV 301, PEV 302) in Tanzania
|
Phase 1 | |
| Completed |
NCT00442377 -
Study to Investigate the Induction of an Protective Immune Response to Malaria
|
N/A | |
| Completed |
NCT00403260 -
Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients
|
Phase 3 | |
| Completed |
NCT01365598 -
Evaluation of the Gametocytocidal Efficacy and Safety of Primaquine in Uncomplicated Falciparum Malaria in Uganda
|
Phase 3 |