None listed
Conditions
Brief summary
This therapeutic efficacy study is to assess the efficacy and safety of the treatment of P. falciparum and p. vivax malaria with Artesunate-Mefloquine and Artesunate-Pyronaridine.
Interventions
It is a single arm open-label study to evaluate therapeutic efficacy and safety of Artesunate-Mefloquine (ASMQ) for the treatment of P. falciparum and P. vivax malaria in Mondulkiri, Rattanakiri and Kratie provinces, and Artesunate-Pyronaridine (ASPY) in Pursat and Kampong Speu provinces. For the ASMQ treatment group, a patient with P. falciparum or P. vivax infection was given a daily dose of 1 tablet for 18-29kg, and 2 tablets for 30 kg body weight or above over 3 days. One tablet of ASMQ contains 100mg Artesunate plus 220mg Mefloquine. Only adults or children with at least 20 kg body weight were treated for the ASPY treatment group. A patient with P. falciparum or P. vivax was given a daily dose of 1 tablet for 20-<24 kg body weight, 2 tablets for 24-<45, 3 tablets for 45-<65 kg body weight, and 4 tablets for 65 kg body weight or above. One table of ASPY contains 60mg Artesunate and 180mg Pyronaridine. A patient is given a full dose if he/she vomits within 30 minutes following the drug administration. A blood smear was examined by microscope every 24 hours until the patient becomes negative over 2 consecutive days. The physical and parasitological examinations are conducted on weekly basis over 28 days for P. vivax patients and 42 days for P. falciparum patients.
Sponsors
Study design
Eligibility
Inclusion criteria
Mono-infection with P. falciparum or P. vivax Axillary above 37.5 Celsius or fever history over the last 24 hours Ability to swallow oral medication Ability and willingness to comply with the study for the duration of the study
Exclusion criteria
Non-malaria febrile Pregnancy or lactation Mixed infection or severe malaria