Trial | NCT00378625  Report issue

Title

Efficacy, Effect on Gametocytes and Tolerability of the Addition of Artesunate to Amodiaquine in Colombia
Randomised, Double Blind Clinical Trial of the Efficacy, Effect on Gametocytes and Tolerability of Amodiaquine Vs Amodiaquine Plus Artesunate in the Treatment of Uncomplicated P. Falciparum Malaria in Quibdo, Colombia

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    artesunate ...

  • Study Participants

    360
The primary goal of this study is to quantify the benefit of adding artesunate to amodiaquine in treating patients with uncomplicated P. falciparum malaria, in a low transmission area in Colombia. The benefit will be assessed in terms of:

Efficacy
Tolerability
Time of fever clearance
Time of parasite clearance
Proportion of gametocyte carriers
Study Started
Apr 30
2000
Study Completion
Mar 31
2006
Last Update
Sep 20
2006
Estimate

Drug Artesunate

Criteria 

Inclusion Criteria:

pure P. falciparum infection
parasitaemia >500 and <50,000 asexual parasites/μL (subsequently the lower limit was modified to >250 asexual parasites/μL)
age between 1 and 65 years old
availability to return for follow-up

Exclusion Criteria:

Pregnancy
history of allergy to the study drugs
history of taken complete treatment with an antimalarial drug in the previous 72 hours or sulphas, clindamycin or tetracycline in the previous week
have a medical history of untreated hypertension or chronic heart, kidney or liver disease
present any danger signs of severe malaria.
No Results Posted