Triple Antimalarial Combination to Accelerate the Parasite Clearance and to Prevent the Selection of Resistant Parasites (Artesynib)
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|ClinicalTrials.gov Identifier: NCT03697668|
Recruitment Status : Unknown
Verified October 2018 by Nurex S.r.l..
Recruitment status was: Recruiting
First Posted : October 5, 2018
Last Update Posted : October 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Plasmodium Falciparum Malaria (Drug Resistant)||Drug: Imatinib Drug: Dihydroartemisinin-piperaquine||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||interventional|
|Masking:||None (Open Label)|
The research method will be a Phase 2 trial, 2 arms, randomized, open label (only the microscopist will be blinded), adaptive, dose de-escalation, trial conducted in adult male subjects with uncomplicated P.falciparum malaria.
In all phases, patients will be treated by a triple combination IMA-DHA-PPQ (ARM 1) or by the standard DHA-PPQ treatment (ARM 2).
|Official Title:||Triple Antimalarial Combination (Imatinib-DHA-PPQ) to Accelerate the Parasite Clearance and to Prevent the Selection of Resistant Parasites|
|Actual Study Start Date :||September 17, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2019|
triple combination for the treatment of malaria
Active Comparator: Dihydroartemisinin-piperaquine
standard of care
standard malaria treatment
- Occurrence of Adverse Events [ Time Frame: From baseline to day 42 ]Occurrence of Adverse Events over 42 days observation period
- Occurrence of Severe Adverse Events [ Time Frame: From baseline to day 42 ]Occurrence of Severe Adverse Events over 42 days observation period
- Occurrence of Abnormal Physical Symptoms [ Time Frame: From baseline to day 42 ]Occurrence of Abnormal Physical Symptoms (Clinical Abnormalities) over 42 days observation period
- Occurrence of Abnormal Laboratory Values [ Time Frame: From baseline to day 42 ]Occurrence of Abnormal Laboratory Values over 42 days observation period
- Frequency of residual parasitemia: % of patients with >1000 parasites/ ul at day 3 and 28 [ Time Frame: day 3 and day 28 ]Parasitemia is determined by assessing the parasite count in blood, using thin film, thick film and qPCR analysis.
- Frequency of fever and malaria symptoms [ Time Frame: day 3 and day 28 ]Percentage of patients with fever or malaria symptoms observed at Phisical Visit at day 3 and 28.
- Mean parasitemia in the control and investigational arms [ Time Frame: day 2 and day 5 ]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
- Parasite half-life measured at 12 and 24 hours [ Time Frame: from baseline to 24 hours post-treatment ]Mean parasite clearance half-life calculated using parasitemia measured at baseline, 12 and 24 hours post-treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697668
|Contact: Huynh D Chien, MD,PhDfirstname.lastname@example.org|
|Contact: Tran A Tuan, MDemail@example.com|
|Hương Hóa, Quang Tri, Vietnam, 520000|
|Contact: Tuan A Tran, MD +84982290426 firstname.lastname@example.org|
|Principal Investigator:||Huynh D Chien, MD, PhD||UNIVERSITY OF HUE, VIETNAM AND VINMEC DANANG INTERNATIONAL HOSPITAL, Hai Chau, Danang.|
|Principal Investigator:||Francesco M Turrini, MD, PhD||University of Turin, Italy|