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CompletedPhase 3ACTRN12609000816257

Pilot Study: Comparison of the efficacy of artemisinin plus piperaquine (Artequick), artesunate plus amodiaquine (Coarsucam) and artesunate plus azithromycin for the treatment of Plasmodium falciparum malaria in Vietnam

Sponsor

Australian Army Malaria Institute

Enrollment

180 participants

Start Date

May 27, 2008

Study Type

Interventional

Conditions

Malaria infection

Summary

Over 80 countries worldwide use artemisinin-based combination therapy (ACT) as first-line treatment of Plasmodium falciparum malaria. Debate continues as to the most effective ACT and how they will be deployed. Which ACT is the best combination therapy for first-line treatment in Vietnam has not been adequately studied. In the present study, we propose to investigate the efficacy and tolerability of three ACTs (artemisinin plus piperaquine, artesunate plus amodiaquine and artesunate plus azithromycin) in central Vietnam.

Eligibility

Sex: Both males and femalesMin Age: 5 YearssMax Age: 65 Yearss

Inclusion Criteria5

  • (i) Sex: male or female
  • (ii) Age: Between 5 years and 65 years old
  • (iii) Falciparum malaria with parasitaemia between 200 and 200,000 parasites/uL of blood
  • (iv) Is willing to give small amounts of blood via finger prick and phlebotomy
  • (vi) Written informed consent and agreed to treatment follow-up for a total of 42 days

Exclusion Criteria4

  • (i) Severe/cerebral malaria or history of another serious medical disease
  • (ii) Prior treatment with an artemisinin drug within the previous 7 days
  • (iii) Pregnancy and lactating
  • (iv) Inability to communicate well with the investigator (poor mental development or evidence of psychiatric disorder)

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Interventions

Malaria patients will be administered either Artequick (2.5 mg/kg artemisinin and 15 mg/kg piperaquine daily) for 2 days, Coarsucam (4 mg/kg artesunate plus 10 mg/kg amodiaquine daily) for 3 days or 4

Malaria patients will be administered either Artequick (2.5 mg/kg artemisinin and 15 mg/kg piperaquine daily) for 2 days, Coarsucam (4 mg/kg artesunate plus 10 mg/kg amodiaquine daily) for 3 days or 4 mg/kg artesunate plus 30 mg/kg azithromycin daily for 3 days. The mode of administration is oral dosing.

Locations(1)

Viet Nam

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