None listed
Conditions
Brief summary
The study is to estimate the efficacy and safety of the treatment of plasmodium falciparum malaria with pyronaridine-artesunate over 42 day.
Interventions
It is a single arm open label study to evaluation of the therapeutic efficacy and safety of pyronaridine-artesunate for the treatment of uncomplicated falciparum malaria. The eligible patients are treated with a daily dose of 1 tablet for 20-<24kg, 2 tablets for 24-<45 kg, 3 tablets for 45-<65kg and 4 tablets for 65 and above over 3 days. One tablet contains 60mg artesunate+18mg pyronaridine. Each dose is administered orally under the supervision of the medical doctor. A dose is repeated in full
It is a single arm open label study to evaluation of the therapeutic efficacy and safety of pyronaridine-artesunate for the treatment of uncomplicated falciparum malaria. The eligible patients are treated with a daily dose of 1 tablet for 20-<24kg, 2 tablets for 24-<45 kg, 3 tablets for 45-<65kg and 4 tablets for 65 and above over 3 days. One tablet contains 60mg artesunate+18mg pyronaridine. Each dose is administered orally under the supervision of the medical doctor. A dose is repeated in full if vomiting occurs within 30 minutes of administration of the first day of administration only. The patients has a blood smear examined daily during the first week by microscopy until parasite clearance (2 consecutive negative slides on two consecutive days; both asexual and sexual stages). The patients has a weekly appointment over 42 days. If the patient do not attend for the follow-up a home-visitor from the study team will try to locate the patient and bring them to the study site.
Sponsors
World Health Organization
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
10 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
- Adults and children with body weight of 20 kg or above - Symptomatic of malaria infection, i.e. history of fever within 24 hours and/or presence of fever 37.5 degree celcius or above - Microscopic confirmation of asexual stages of P. falciparum (P. falciparum and mixed infection in Pailin only) - Capability of taking an oral medication
Exclusion criteria
- Pregnancy or lactation (urine test for beta HCG to be performed on any woman of child bearing age, that is 18 to 45 years old) - Female aged 12-18y - Parasitemia less than 150 000/microlitre). - Signs or symptoms indicative of severe malaria: - Impaired consciousness (Blantyre Coma Score less than 5) - Severe anaemia (Hct less than15%)
Outcome results
None listed