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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 of artesunate-amodiaquine over 28 days in the treatment of uncomplicated falciparum malaria in Cambodia

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000638730
Enrollment
54
Registered
2022-05-02
Start date
2020-06-01
Completion date
2020-10-31
Last updated
2022-05-09

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 study was to monitor and evaluate 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

Interventions

ASMQ (Artesunate + Mefloquine co-formulated). The adult dose tablet contains 100mg Artesunate plus 220mg Mefloquine and the pediatric tablet contain 55mg Artesunate plus 55 mg Mefloquine. ASP (Artesunate + Pyronaridine/ Pyramax): Adults and children greater than or equal to 20 kg. All doses of medicine will be administered under the supervision of a qualified member of the staff designated by the principal investigator. The study patients will be observed for 30 min after medicine administration

ASMQ (Artesunate + Mefloquine co-formulated). The adult dose tablet contains 100mg Artesunate plus 220mg Mefloquine and the pediatric tablet contain 55mg Artesunate plus 55 mg Mefloquine. ASP (Artesunate + Pyronaridine/ Pyramax): Adults and children greater than or equal to 20 kg. All doses of medicine will be administered under the supervision of a qualified member of the staff designated by the principal investigator. The study patients will be observed for 30 min after medicine administration for adverse reactions or vomiting. Any patient who vomits during this observation period will be re-treated with the same dose of medicine and observed for an additional 30 min. If the patient vomits again, he or she will be withdrawn and offered rescue therapy. The patients are recommended to stay at the health facility until they complete the treatment course for malaria infection. This surveillance study is a one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria. Eligible patients were treated with a daily dose of 1 tablet containing 135mg amodiaquine 'AQ' and 50mg artesunate 'AS' for the patients with 8-17 kg body weight over 3 days, 1 tablet containing 270mg amodiaquine 'AQ' and 100mg artesunate 'AS' for the patients with 17-35 kg body weight and 2 tablets for the patients above 35 kg body weight over 3 days. In addition, a single oral dose of 15-mg adult dose of Primaquine was given to the patient on the first day of treatment. The blood slide was examined daily until the patient was negative on 2 consecutive days. The patients took each dose of the drug before the health stay, stayed at the study site for the first 3 or 4 days, and returned to the study site weekly over 28 days.

Sponsors

Ministry of Health
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
2 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

The study population consisted of patients with uncomplicated P. falciparum or P. vivax malaria attending the study health clinic who are aged between 2-60 years for ASP and 18-60 years for ASMQ. All adult patients were above 18 years, age of majority in this country, signed an informed consent form for participation. Parents or guardians were informed consent on behalf of children who have not reached the age of majority. Children aged from 12 years and age of majority are required to consent for participation by signing an informed assent form.

Exclusion criteria

- Pregnancy or lactation - Severe malaria - Mixed malaria infection

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026