Plasmodium Falciparum Artemisinin Resistance Vietnam
|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
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|