None listed
Conditions
Brief summary
This therapeutic efficacy study was to assess the efficacy and safety of the treatment of P. falciparum malaria with pyronaridine-artesunate
Interventions
It is a single arm open-label study to evaluate therapeutic efficacy and safety of Pyronaridine-Artesunate for the treatment of Plasmodium falciparum malaria. Eligible patients were treated with a daily dose of 1 tablet for the patients 20-<24 kg body weight, 2 tablets for 24-<45 kg body weight, 3 tablets for 45-<65 kg body weight and 4 tablets for the patients over 65 kg over 3 days. One tablet contains 60mg artesunate plus 18 mg pyronaridine. The patients took the drugs in front of the field-based medical doctor. A full dose was repeated if a patient vomited within 30 minutes following the drug administration. The patients had a blood smear examined by microscope on a daily basis until they were negative on 2 consecutive days. The patients were to visit the study site once a week over 42 days. The patient's home visit was conducted when any patient did not come as the appointment schedule.
Sponsors
Study design
Eligibility
Inclusion criteria
- Adults and children with the body weight of 20 kg or above - Mono-infection with P. falciparum - History of fever within 24 hours or presence of axillary (under the armpit) above 37.5 °C - Ability to swallow medication - Ability and willingness to comply with the study protocol during the study period
Exclusion criteria
- Presence of non-malaria febrile conditions - Pregnancy or lactation - Severe malaria