None listed
Conditions
Brief summary
The purpose of this study is to assess the effectiveness, safety and tolerability of a new antimalarial drug combination called pyronaridine-artesunate for the treatment of malaria in 120 participants living in Dak Nong Province of the central highlands of Vietnam. The study will provide important information to the Ministry of Health in Vietnam for the selection of the best drug to treat multiple drug-resistant malaria infections.
Interventions
Participants with blood smear positive malaria will be treated with the fixed dose combination of pyronaridine-artesunate (registered as Pyramax). Each tablet of pyronaridine-artesunate contains 60 mg artesunate + 180 mg pyronaridine. The dose of pyronaridine-artesunate will be in accordance to the participant's body weight with the target dosage range for pyronaridine–artesunate of 7.2 to 2.4 mg/kg/day of body weight to 13.8 to 4.6 mg/kg/day. Pyronaridine–artesunate will be administered orally,
Participants with blood smear positive malaria will be treated with the fixed dose combination of pyronaridine-artesunate (registered as Pyramax). Each tablet of pyronaridine-artesunate contains 60 mg artesunate + 180 mg pyronaridine. The dose of pyronaridine-artesunate will be in accordance to the participant's body weight with the target dosage range for pyronaridine–artesunate of 7.2 to 2.4 mg/kg/day of body weight to 13.8 to 4.6 mg/kg/day. Pyronaridine–artesunate will be administered orally, at about 24 hour intervals for the 3 consecutive days. Adherence to dosing will be by direct observation.
Sponsors
US Naval Medical Research Center-Asia and US Naval Medical Research Unit - Two
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adults and children with a body weight greater than or equal to 20 kg • Symptomatic of malaria infection (i.e. history of fever within 24 hours and/or presence of fever greater than 37.5°C for axillary temperature or greater than 38.0°C for tympanic temperature. • Microscopic confirmation of asexual (i.e. blood) stages of mono-infections of P. falciparum, P. vivax and P. malariae or mixed infections of the Plasmodium species. • Parasitemia between 250/µL and less than 100 000/µL of blood. • Glucose-6-Phosphate Dehydrogenase (G6PD) normal participants with mono-infection of P. vivax or mixed infections of P. vivax will be treated with primaquine to kill liver hypnozoites. • Ability to take oral medication. Written informed consent given to participate in the trial by the patient or in case of children up to 17 years old (assent for children aged 10 to 17 years old) with adult or guardian permission.
Exclusion criteria
• Pregnancy or lactation (urine test for ß HCG to be performed on any woman of child bearing age 10 to 55 years old). • Hematocrit less than 20%. • Parasitemia less than 250/µL or greater than 100 000/µL of blood. • Signs or symptoms indicative of severe/cerebral malaria (WHO, 2014). • Liver function test (AST/ALT levels) more than 2.5 times the upper limit of normal (ULN) range. • Total bilirubin greater than 2 ULN. • Use of an antimalarial drug in the preceding 4 weeks. • History of splenectomy, heavy alcohol use or injecting drugs of abuse. • Any other condition, which in the judgment of the study physician would make participation in the study unsafe for the potential study participant.
Outcome results
None listed