Intervention: Artecom
Trial phase: Phase 2
SMILES: CC1CCC2C(C)C(OC(=O)CCC(=O)O)OC3OC4(C)CCC1C32OO4.COc1ccc2nc3cc(Cl)ccc3c(Nc3cc(CN4CCCC4)c(O)c(CN4CCCC4)c3)c2n1.O=P(O)(O)O.O=P(O)(O)O.O=P(O)(O)O.O=P(O)(O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 15
Group description: Pyronaridine artesunate 12:4 mg/kg
Eligibility criteria:
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 Criteria 2000
Mixed Plasmodium infection
Severe vomiting, defined as >3 times in the 24 hours prior to inclusion in the study or inability to tolerate oral treatment, or severe diarrhoea defined as >3 watery stools per day
Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, acute QTc interval greater or equal to 450 msec), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other abnormality (including head trauma)
Presence of febrile conditions caused by diseases other than malaria
Known history of hypersensitivity, allergic or adverse reactions to pyronaridine or artesunate or other artemisinins
Use of any other antimalarial treatment within 2 weeks prior to start of the study as confirmed by Lignin test and Saker Solomon urine test
For females of childbearing potential, positive urine pregnancy test or lactating
Use of an investigational drug within the past 8 weeks
Known active Hep A immunoglobulin, Hep B surface antigen, or Hep C antibody
Known seropositive HIV antibody
Liver function tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] levels) >3 times the upper limit of normal
Known significant renal impairment as indicated by a serum creatinine ≥2 mg/dL
Previous participation in this clinical study