Plasmodium Falciparum Artemisinin Resistance Vietnam
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|ClinicalTrials.gov Identifier: NCT01775592|
Recruitment Status : Completed
First Posted : January 25, 2013
Last Update Posted : January 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|Plasmodium Falciparum||Drug: Arterakin (DHA-PPQ)||Phase 4|
General objective To evaluate the efficacy of DHA-PPQ in patients with uncomplicated falciparum malaria in a rural area of Central Vietnam, and to assess the in vitro susceptibility of P.falciparum isolates to DHA and PPQ.
- To measure the parasite clearance time in falciparum malaria patients treated with DHA-PPQ.
- To determine the efficacy of DHA-PPQ at day 42 post-treatment.
- To assess the in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province.
- To compare genetic profiles of P.falciparum isolates with delayed and those with normal clearance times in order to identify potential markers of resistance;
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Monitoring the Efficacy of Dihydroartemisinin - Piperaquine in Patients With Uncomplicated Falciparum Malaria in Traleng Commune, Central Vietnam|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Number of DHA- PPQ (Arterakin™) tablets per day at 0hour, 8hours, 24hours, 48hours (according to age): 2 - 3 years:0.5, 0.5, 0.5, 0.5 3 - < 8 years: 1.0, 1.0, 1.0, 1.0 8 - < 15 years:1.5, 1.5, 1.5, 1.5
≥ 15 years:2.0, 2.0, 2.0, 2.0
Drug: Arterakin (DHA-PPQ)
- Parasite clearance time [ Time Frame: Day 2-5 ]
- efficacy of DHA-PPQ at day 42 post-treatment in Traleng Quangnam, Vietnam [ Time Frame: Day 42 ]treatment failure or success at day 42
- in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province [ Time Frame: Day 3-10 ]MarkIII in vitro test
- genetic profiles of P.falciparum isolates with delayed and those with normal clearance times in order to identify potential markers of resistance [ Time Frame: 1year ]genotyping
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): NCT01775592
|Health Centre Tra Leng|
|Tra Leng, Quang Nam, Vietnam|
|Principal Investigator:||Annette Erhart, MD, PhD||ITM|