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

Clinical and parasitological efficacy over 42 days of artesunate-pyronaridine in the treatment of uncomplicated falciparum malaria in 2 provinces in Cambodia

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001300268
Acronym
Nil
Enrollment
111
Registered
2018-08-02
Start date
2017-10-17
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 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-

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

Ministry of Health
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 3, 2026