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

Phase 2

Completed

• Conditions: malaria; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12618001952235
• Lead Sponsor: WHO country office

Brief Summary

Both A-L and P-A are efficacious for treatment of uncomplicated falciparum malaria while P-A is also for vivax malaria

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-01-31
• Study Start: 2018-12-03
• Last Update Posted: 10 December 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adequate Clinical and Parasitological Response (ACPR)<br>Assessment was done by measuring body temperature ( tympanic temperature) using digital thermometer. and microscopic examination of Giemsa stained blood smear (thick film)..<br>If body temperature reaches 37 C on day 3 and no presence of fever throughout the follow-up up to 42 days and<br>Asexual malaria parasites are absent on day 3 and disappearance throughout the follow-up visits by microscopic examination, the patient is categorized as Adequate Clinical and Parasitological Response (ACPR) [28 days post treatment<br>Patient was treated on Day 0 and follow up was done on Day 1,,2,,3, 7, 14, 21 and 28 days respectively]

Secondary Outcome Measures

Name	Time	Method
Early Treatment Failure ETF<br>Assessment was done by measuring body temperature ( tympanic temperature) using digital thermometer. and microscopic examination of Giemsa stained blood smear (thick film)..<br>If the patient has body temperature more than 37.5 C on day 3 (or)<br>If asexual parasites still appear on bay 3 by microscopic examination<br>[28 days<br>Patient was treated on Day 0 and follow up was done on Day 1,,2,,3, 7, 14, 21 and 28 days respectively]