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Efficacy and safety of Artemether-Lumefantrine (A-L) for P.falciparum malaria and Pyronaridine-Artesunate (P-A) for treatment of uncomplicated Plasmodium falciparum malaria and P. vivax malaria in Myit Kyi Nar township, Kachin state and Kyauk Mee township, Northern Shan state

Testing efficacy and safety of A-L for falciparum malaria and P-A for falciparum and vivax malaria in Myit KyiNar township, Kachin state and Kyauk Mee township, Northern Shan state

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001952235
Enrollment
45
Registered
2018-12-03
Start date
2017-08-01
Completion date
2017-12-25
Last updated
2018-12-10

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

Conditions

None listed

Brief summary

The study aimed to assess efficacy and side effects of two ACTs for treatment of uncomplicated falciparum malaria using WHO standard protocol in two sentinel sites of Upper Myanmar..

Interventions

Non- randomized controlled trial for falciparum malaria, where one arm was given A-L and the second arm was given P-A . All falciparum patients who met the inclusion criteria were enrolled. Odd numbers were given A-L which was given as oral tablets twice a day for three according to the dosing chart. A-L ( each tablet contains 20 mg artemether & 120 mg lumefantrine) was given according to the body weight as: (a) 15-24 Kg.body weight: two tablets twice a day for three days (b) 25-34 Kg.body weig

Non- randomized controlled trial for falciparum malaria, where one arm was given A-L and the second arm was given P-A . All falciparum patients who met the inclusion criteria were enrolled. Odd numbers were given A-L which was given as oral tablets twice a day for three according to the dosing chart. A-L ( each tablet contains 20 mg artemether & 120 mg lumefantrine) was given according to the body weight as: (a) 15-24 Kg.body weight: two tablets twice a day for three days (b) 25-34 Kg.body weight: three tablets twice a day for three days (c) 35 and above: four tablets twice a day for three days Even numbers were administered oral P-A tablet ( each tablet contains Pyronaridine 60 mg & artesunate 20 mg) was given according to the body weight as: (a) 20-24 Kg.body weight: one tablet three times a day for three days (b) 25-44 Kg.body weight: two tablets three a day for three days (c) 45 - 65 Kg. body weight : three tablets three times a day for three days Adherence of treatment was monitored by asking to show the the empty drug card in the follow up visits. Patients having P.vivax as detected ny microscopic examination were treated with P-A while the dosage was the same for P. falciparum malaria.

Sponsors

WHO country office
Lead SponsorOther

Study design

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

Eligibility

Sex/Gender
All
Age
6 Years to No maximum
Healthy volunteers
No

Inclusion criteria

For Plasmodium falciparum malaria Patients having asexual parasites of Plasmodium falciparum between 1000-100000 per micro-liter in blood Patients having ages of six years and above will be included Patients who do not have signs and symptoms of severe and complicated malaria Patients who do not have known chronic diseases: Tuberculosis, HIV/AIDS, Malignancies Patients who have not anti-malarials in the past 14 days For Plasmodium vivax malaria Patients having asexual parasites of Plasmodium vivax at least 500-50,000 per micro-liter in blood Patients having ages of six years and above will be included Patients who do not have signs and symptoms of severe and complicated malaria Patients who do not have known chronic diseases: Tuberculosis, HIV/AIDS, Malignancies Patients who have not anti-malarials in the past 14 days P-A was studies for both P.falciparum and P..vivax malaria, while A-L was studies only for P. falciparum malaria

Exclusion criteria

patients having severe and complicated malaria

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026