P. Falciparum Resistance to Artemisinin in Vietnam
Status:
Unknown status
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
At the end of 2012, the Institute of Tropical Medicine in collaboration with National
Institute of Malariology Parasitology and Entomology (NIMPE) conducted a study in Quang Nam
province, central Vietnam, to assess the efficacy of the national DHA-PPQ regimen for the
treatment of uncomplicated P. falciparum malaria infections, both in adults and in children.
Results showed that about 30% of the study participants were parasitaemic at day 3. Parasite
clearance rate was estimated at 6.2h, which was comparable to figures from Pailin, Cambodia,
where artemisinin resistance were previously reported . However, results from this study have
to be interpreted bearing in mind that: (i) the age-based drug dosing scheme used has been
criticized as insufficient to clear parasites and (ii) DHA-PPQ drugs used (Artecan™),
Vietnam, are not produced under Good Manufacturing Practices (GMPs). However, those results
prompted the NMCP and WHO to declare Quang Nam, Binh Phuoc, Dak Nong, and Gia Lai provinces
as a "Tier I area" (credible evidence of artemisinin resistance) in May 2013. By end of 2014
a fifth province, Khanh Hoa, was declared Tier I (Dr Hong, Personal Communication). Except
for the south-eastern province of Binh Phuoc, artemisinin resistance has never been confirmed
with an artemisinin based monotherapy in Central Vietnam.
Therefore, in order to confirm artemisinin resistance in Central Vietnam , a study with oral
artemisinin-based monotherapy, using WHO prequalified AS and DHA-PPQ and recommended dosing
scheme of 4mg/kg/day for AS and DHA, is needed. In the arm where study participants are
treated with 3 days of AS monotherapy, treatment will be followed by an additional 3-day
course of DHA-PPQ to effectively clear all parasites.
The aim of the present study is to confirm artemisinin resistance in Central Vietnam by
assessing P. falciparum clearance time and rate after AS monotherapy (WHO recommended
dosage). The investigators will conduct a two-arm open label, randomized study, with one arm
receiving AS monotherapy for 3 days + 3-day of DHA-PPQ, and a second arm receiving 3 days of
DHA-PPQ.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Malariology, Parasitology and Entomology, Vietnam