Trial | NCT00845533  Report issue

Title

Pharmacokinetics of Dihydroartemisinin-Piperaquine in the Treatment of Uncomplicated Malaria in Children in Burkina Faso

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
This will be an open-label trial in Burkina Faso assessing the pharmacokinetics of the antimalarial combination of dihydroartemisinin/piperaquine (DP, Duocotexcin) in children. Dihydroartemisinin-piperaquine is a promising candidate for first-line therapy of malaria. We hypothesize that the disposition and pharmacokinetics of DP will be altered in children, and this will alter the efficacy and/or toxicity of DP. We will test this hypothesis in this open-label trial in Burkina Faso. The target population includes residents, aged 6 months to 10 years in Bobo-Dioulasso. Children who present to the study clinics with symptoms suggestive of malaria will be screened with a thick blood smear. Subjects who meet selection criteria of treatment efficacy will be treated and followed up for 42 days. Pharmacokinetic sampling for DP will occur on selected follow-up days.
Study Started
Aug 31
2007
Primary Completion
Dec 31
2007
Study Completion
Jan 31
2009
Last Update
Jan 16
2014
Estimate

Drug Dihydroartemisinin-Piperaquine

Criteria 

Inclusion Criteria:

Positive screening thick blood smear
Fever (> 37.5ºC axillary) or history of fever in the previous 24 hours
Age ≥ 6 months to 10 years
Weight > 5 kg
Absence of any history of serious side effects to study medications
No evidence of a concomitant febrile illness in addition to malaria
No history of antimalarial use in the previous two weeks
P. falciparum mono-infection
Parasite density 2000-200,000/ul
Provision of informed consent and ability to participate in 42-day follow-up

Exclusion Criteria:

Danger signs or evidence of severe malaria
Hemoglobin levels < 5.0 gm/dL
No Results Posted