Plasmodium Falciparum Clinical Trial
Official title:
Efficacy and Safety of a Single Low-dose Primaquine Added to Standard Artemether-lumefantrine Treatment for the Clearance of Plasmodium Falciparum Gametocytes.
The purpose of this study is to assess efficacy and safety of a single low-dose Primaquine added to standard artemether/lumefantrine treatment for the clearance of Plasmodium falciparum gametocytes among patients with uncomplicated malaria aged 1 year and above regardless of their G6PD status.
The current gained successes in malaria control are accredited partly to the availability of
efficacious and fast acting artemisinins which are also potent against P. falciparum young
gametocytes. Nonetheless, mature gametocytes may persist after treatment, contributing to
malaria transmission. Conversely, artemisinin resistance is confirmed in South-east Asia,
and it may spread to Africa. New control tools have to be integrated to sustain the gained
successes, further reduce transmission and curb the spread of resistance.
Primaquine has strong gametocytocidal effect against mature gametocytes and when added to
schizonticidal drugs such as artemether-lumefantrine (AL), it rapidly shorten gametocytes
carriage duration, halting disease transmission. Nonetheless, its wide scale use has been
hampered by a dose-dependent acute hemolytic anemia it causes in glucose-6-phosphate
dehydrogenase (G6PD) deficient individuals. Conversely, Artemisinins potentiate primaquine
activities, thus a low dose of primaquine would be able to clear falciparum gametocytes.
The World Health Organization recommends addition of 0.25 mg/kg single-dose primaquine to
Artemisinin based combination therapies in malaria endemic areas including Africa without
testing for G6PD status. Nonetheless, the recommendation, relies on historical data from
South-East Asia and among African Americans in the United States. Therefore, this study
plans to assess safety and efficacy of 0.25 mg/kg single-dose primaquine added to a standard
AL treatment against P. falciparum gametocytes clearance among patients with uncomplicated
malaria aged 1 year and above regardless of their G6PD status..
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01935882 -
Low Dose Primaquine for Clearance of Gametocytes
|
Phase 2/Phase 3 | |
Completed |
NCT01728701 -
Controlled Human Malaria Infection (CHMI) After Immunization With Cryopreserved Plasmodium Falciparum Sporozoites Under Chloroquine Prophylaxis
|
Phase 1 | |
Completed |
NCT01775592 -
Plasmodium Falciparum Artemisinin Resistance Vietnam
|
Phase 4 | |
Completed |
NCT00914225 -
Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya
|
N/A | |
Completed |
NCT02895568 -
Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers
|
||
Completed |
NCT02259426 -
Dihydroartemisinin-piperaquine With Low Dose Primaquine to Reduce Malaria Transmission
|
Phase 3 | |
Completed |
NCT01465048 -
Optimisation of Controlled Human Malaria Infection Using Sporozoites Administered by Needle and Syringe
|
N/A | |
Completed |
NCT00392015 -
NMRC-M3V-Ad-PfCA Vaccine - Clinical Trial 1
|
Phase 1/Phase 2 | |
Completed |
NCT04661579 -
RTS,S/AS01E Hypo-immuno-responsiveness Study
|
Phase 2 | |
Recruiting |
NCT05400746 -
A Study of the Plasmodium Falciparum Malaria Vaccine Candidate Pfs48/45 in Matrix-M Adjuvant in the UK
|
Early Phase 1 | |
Completed |
NCT03138096 -
Safety and Protective Efficacy of Pb(PfCS@UIS4)
|
Phase 1/Phase 2 | |
Completed |
NCT03452475 -
Comparison of Arterolane-piperaquine Versus Arterolane-piperaquine+Mefloquine Versus Artemether-lumefantrine in Kenyan Children
|
Phase 3 | |
Completed |
NCT00295581 -
PpPfs25/ISA51 and ScPvs25/ISA51 Vaccines for Malaria
|
Phase 1 | |
Withdrawn |
NCT04203186 -
A Clinical Trial to Evaluate Plasmodium Falciparum 7G8 and NF54 Challenge Strains (PfSPZ) in a Head-to-head Comparative Study - (ECG-CHMI)
|
N/A | |
Completed |
NCT02418962 -
Safety and Immunogenicity of Direct Venous Inoculation of a Radiation-attenuated PfSPZ Vaccine in Equatoguinean Adults
|
Phase 1 | |
Completed |
NCT01160562 -
Pilot Study to Estimate the Burden and Distribution of Plasmodium Falciparum Malaria in Kalifabougou, Mali in Preparation for a Prospective Cohort Study of Naturally-Acquired Malaria Immunity
|
||
Terminated |
NCT04445103 -
The Malaria Heart Disease Study
|
||
Completed |
NCT03132402 -
ELISA Validation of Hypersensitive Rapid Diagnostic Test Results for Detection of P. Falciparum
|
||
Completed |
NCT03172221 -
Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women
|
||
Not yet recruiting |
NCT03219281 -
Prevalence Survey of Antimalarial Drug Resistance Markers at Sites in India
|
N/A |