Pyronaridine and Artesunate (3:1) in Children With Acute Uncomplicated Plasmodium Falciparum Malaria (NCT00331136) | Clinical Trial Compass
CompletedPhase 2
Pyronaridine and Artesunate (3:1) in Children With Acute Uncomplicated Plasmodium Falciparum Malaria
Gabon60 participantsStarted 2006-06
Plain-language summary
The purpose of this study is to evaluate three dose levels of a combination tablet and a fixed dose granule formulation of pyronaridine and artesunate (PA) for the treatment of acute uncomplicated falciparum malaria in children.
Who can participate
Age range2 Years – 14 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients presenting with symptoms of acute uncomplicated falciparum malaria with the following inclusion criteria:
* Male or female children, being between 2 and 14 years of age inclusive
* Weight between 10 and 40 kg inclusive
* Written informed consent, in accordance to local practice, provided by parent/guardian. If the parent/guardian is unable to write, witnessed consent is permitted according to local ethical considerations. Where possible, parent assent will be sought
* Absence of severe malnutrition (defined as mid upper arm circumference \<110mm)
* Presence of acute symptomatic uncomplicated P. falciparum malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P. falciparum only (i.e. no mixed infection) plus measured temperature of ≥37.5°C (depending on method of measurement as below) or history of fever within the past 24 hours :
* the acceptable range is between 1,000 and 200,000 asexual parasite count/μl of blood and
* axillary/tympanic temperature of ≥37.5°C or oral/rectal temperature of ≥38.0°C
* Females of childbearing potential are not allowed to be pregnant or lactating and must be willing to use adequate measures of contraception during the study period
* Ability to comply with the study visit schedule and the study protocol for the duration of the study
Exclusion Criteria:
* Patients with signs and symptoms of severe/complicated malaria requiring parenteral antimalarial treatment according to the WHO Crite…
What they're measuring
1
Percentage of Patients With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28