Plasmodium Falciparum Artemisinin Resistance Vietnam
Resistance of Plasmodium falciparum toward Artemisinins, the most important drug for the successful treatment of malaria, has been confirmed in Cambodia. There are few reports from neighbouring countries about delayed parasite rates. The investigators therefore aim to assess parasite clearance in malaria patients in central Vietnam when treated according to national standard guidelines.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Monitoring the Efficacy of Dihydroartemisinin - Piperaquine in Patients With Uncomplicated Falciparum Malaria in Traleng Commune, Central Vietnam|
- Parasite clearance time [ Time Frame: Day 2-5 ] [ Designated as safety issue: No ]
- efficacy of DHA-PPQ at day 42 post-treatment in Traleng Quangnam, Vietnam [ Time Frame: Day 42 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]genotyping
|Study Start Date:||September 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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)
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;
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775592
|Health Centre Tra Leng|
|Tra Leng, Quang Nam, Vietnam|
|Principal Investigator:||Annette Erhart, MD, PhD||ITM|