The purpose of this study is to provide a new drug combination for a better treatment of P. falciparum for a faster parasite clearance and to counteract artemisinin resistance.
According to WHO, resistance to artemisinin derivatives (ART) is emerging in many areas of the Greater Mekong Region as a delayed parasite clearance following a standard treatment by artemisinin combined therapy (ACT). Artemisinin resistance is often accompanied by the resistance to the partner drugs such as piperaquine (PPQ), mefloquine (MEF), amodiaquine (AQ) and lumefantrine (LF). The slow and incomplete clearance of parasites following ACT treatment is considered to permit the selection of resistant parasites. The availability of new, more efficient treatments accelerating the clearance of parasites is therefore needed to counteract the selection of ART resistant strains. Imatinib (IMA) has been demonstrated to increase the efficacy of ART in a synergic fashion. This positive effect is further potentiated by low concentrations of PPQ. IMA is active both on the intra-erythrocyte asexual forms and on gametocytes. It is therefore expected that the combination DHA-PPQ-IMA should lead to faster and radical clearance of the parasites, therefore reducing the frequency of healthy carriers and transmission.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
triple combination for the treatment of malaria
standard malaria treatment
A Tuc
Hương Hóa, Quang Tri, Vietnam
RECRUITINGOccurrence of Adverse Events
Occurrence of Adverse Events over 42 days observation period
Time frame: From baseline to day 42
Occurrence of Severe Adverse Events
Occurrence of Severe Adverse Events over 42 days observation period
Time frame: From baseline to day 42
Occurrence of Abnormal Physical Symptoms
Occurrence of Abnormal Physical Symptoms (Clinical Abnormalities) over 42 days observation period
Time frame: From baseline to day 42
Occurrence of Abnormal Laboratory Values
Occurrence of Abnormal Laboratory Values over 42 days observation period
Time frame: From baseline to day 42
Frequency of residual parasitemia: % of patients with >1000 parasites/ ul at day 3 and 28
Parasitemia is determined by assessing the parasite count in blood, using thin film, thick film and qPCR analysis.
Time frame: day 3 and day 28
Frequency of fever and malaria symptoms
Percentage of patients with fever or malaria symptoms observed at Phisical Visit at day 3 and 28.
Time frame: day 3 and day 28
Mean parasitemia in the control and investigational arms
Mean parasitemia by assessing the parasite count in blood, using thin film, thick film and qPCR analysis, expressed as parasites / ul at day 2, 3 and 5 measured in the control and investigational arms
Time frame: day 2 and day 5
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Parasite half-life measured at 12 and 24 hours
Mean parasite clearance half-life calculated using parasitemia measured at baseline, 12 and 24 hours post-treatment
Time frame: from baseline to 24 hours post-treatment