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Monitoring and evaluation of the efficacy and safety of Artesunate-Mefloquine with a low single dose of Primaquine for the treatment of uncomplicated Plasmodium malaria in Cambodia

Clinical and parasitological efficacy over 42 days of Artesunate-Mefloquine in the treatment of uncomplicated Plasmodium falciparum in 3 provinces in Cambodia

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001301257
Acronym
Nil
Enrollment
167
Registered
2018-08-02
Start date
2017-10-23
Completion date
2018-02-21
Last updated
2018-08-20

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 was to assess the efficacy and safety of the treatment of P. falciparum malaria with Artesunate-Mefloquine.

Interventions

It is a single arm open-label study to evaluate therapeutically efficacy and safety of Artesunate-Mefloquine for the treatment of P. falciparum malaria. Eligible patients were treated with a daily dose of 1 tablet for 18-29 kg, and 2 tablets for 30 kg body weight over 3 days. One tablet contains 100 mg Artesunate plus 220mg Mefloquine. The patients took the drugs in front of the field-based medical doctor and a complete dose was repeated if a patient vomited within 30 minutes following the drug

It is a single arm open-label study to evaluate therapeutically efficacy and safety of Artesunate-Mefloquine for the treatment of P. falciparum malaria. Eligible patients were treated with a daily dose of 1 tablet for 18-29 kg, and 2 tablets for 30 kg body weight over 3 days. One tablet contains 100 mg Artesunate plus 220mg Mefloquine. The patients took the drugs in front of the field-based medical doctor and a complete dose was repeated if a patient vomited within 30 minutes following the drug administration. A blood smear was examined by the microscope on a daily basis until a patient became negative over 2 consecutive days. Then, the patients were asked to return to the study site once a week over 42 days. A home visit was made when any patient missed the appointment.

Sponsors

Ministry of Health
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Single group
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 Axillary above 37.5 °C or history of fever over the past 24 hours. Ability to swallow oral medication Ability and willingness to comply with the study protocol for the duration of the study

Exclusion criteria

Presence of non-malaria febrile conditions Pregnancy or lactation Severe malaria

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026