P. Falciparum Resistance to Artemisinin in Vietnam

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Malariology, Parasitology and Entomology, Vietnam
• Collaborator: Institute of Tropical Medicine, Belgium
• Treatments: Artemisinine; Artemisinins; Artesunate

Criteria

Inclusion Criteria:

• Mono-infection with P. falciparum;

• Parasite density (trophozoites) between 500-100,000/µl;

• Fever (axillary temperature 37.5C) or history of fever in the previous 24h.;

• Ability to swallow oral medication;

• Ability and willingness to comply with the study protocol and with the study visit schedule;

• Written informed consent/assent to participate to the trial.

Exclusion Criteria:

• Mixed or mono-infection with another Plasmodium species confirmed by microscopy;

• General danger signs or symptoms of severe malaria according to WHO definitions;

• Signs or symptoms of severe malnutrition (weight-for-age ≤ 3 standard deviations below the mean (NCHS/WHO normalized reference values));

• Anaemia (Hb <7g/dl in adults (<5g/dl in children));

• Pregnancy or lactation (urine test for β HCG);

• Concomitant acute illness necessitating specific treatment (antibiotics);

• Underlying chronic severe illness (e.g. cardiac, renal, hepatic diseases, HIV/AIDS);

• Known hypersensitivity to any of the drugs being evaluated;

• Regular use of medication that may interfere with antimalaria pharmacokinetics