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Monitoring and evaluation of the efficacy and safety of Artesunate-Mefloquine (ASMQ) and Artesunate-Pyronaridine (ASP) for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in Cambodia

Clinical and parasitological efficacy over 42 days of Artesunate-Mefloquine and Artesunate-Pyronaridine in the treatment of uncomplicated Plasmodium falciparum and vivax malaria in 5 provinces in Cambodia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001999224
Acronym
Nil
Enrollment
425
Registered
2018-12-13
Start date
2018-09-12
Completion date
2019-02-04
Last updated
2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 cont

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

National Center for Parasitology, Entomology, and Malaria Control
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
15 Years to 65 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 1, 2026