Sponsor study identifier
observational
80
0 countries
N/A
Study Start
January 2, 2017
Actual (reported)Primary Completion
December 28, 2018
Actual (reported)Study Completion
December 28, 2018
Actual (reported)The emergence and spread of drug resistance is a major obstacle to combating malaria. The World Health Organization (WHO) recommends that regular efficacy monitoring should be undertaken by all malaria endemic countries that have deployed artemisinin combination therapy (ACT), to help early detection of drug resistant strains of the parasite and contain their rapid spread. Artemether-lumefantrine (AL) has been the first-line antimalarial drug against uncomplicated Plasmodium falciparum malaria in the Philippines since 2009, with primaquine as an anti-relapse drug. The objective of this study is to assess the safety and efficacy of artemether-lumefantrine for the treatment of uncomplicated P. falciparum infections in the Philippines. The study was conducted in three (3) municipalities (Bataraza, Brooke's Point, and Rizal) of Palawan. Single-arm prospective study of a 28-day follow-up was conducted from February 2017 to December 2018 according to the revised WHO 2014 drug efficacy study protocol. Study subjects were consenting individuals seeking care at the selected Rural Health Units, who were aged \>6 months old to 59 years old with confirmed uncomplicated P. falciparum infections. AL was administered for 3 days according to body weight (Days 0, 1 and 2) and primaquine 0.75 mg/kg body weight single dose was given on Day 3 following the National Treatment Guidelines.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 28, 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2, 2017
Actual (reported)December 28, 2018
Actual (reported)December 28, 2018
Actual (reported)June 30, 2023
Actual (reported)July 25, 2023
Actual (reported)Number of Patients with Early Treatment Failure (ETF)
The number of patients with the following criteria based on microscopy results without PCR: * Development of danger signs or severe malaria on day 1, day 2, or day 3 in the presence of parasitemia; * Parasitaemia on day 2 higher than day 0 count irrespective of axillary temperature; * Parasitaemia on day 3 with axillary temperature ≥37.5 ºC; * Parasitaemia on day 3 ≥25% of count on day 0.
Day 1-3
Late Clinical Failure (LCF)
The number of patients with the following criteria based on microscopy results without PCR: * Development of danger signs or severe malaria on any day from day 4 to day 28 in the presence of parasitemia, without previously meeting any of the criteria of Early Treatment Failure; * Presence of parasitemia and axillary temperature ≥37.5 ºC (or history of fever in low/moderate transmission areas) on any day from day 4 to day 28, without previously meeting any of the criteria of Early Treatment Failure.
Day 4-28
Number of Patients with Late Parasitological Failure (LPF)
The number of patients with the presence of parasitemia on any day from day 7 to day 28 and axillary temperature \<37.5 ºC, without previously meeting any of the criteria of Early Treatment Failure or Late Clinical Failure.
Patients with mono-infection of Plasmodium falciparum with 1,000-100,000 asexual forms per µl
Artemether-lumefantrine will be administered for 3 days according to body weight (Days 0 and 8 hours after, 1 and 2). Dosage depending on body weight or age if weight cannot be determined. Dosage: 1 tablet contains 20 mg artemether and 120 mg lumefantrine Dosage per weight: 1 tablet (5 to \<16kg); 2 tablets (15 to \<25kg); 3 tablets (25 to \<35kg), 4 tablets for \>35 kg) Dosage per age, if weight cannot be determined: 1 tablet (6 months old to 3 years old); 2 tablets (4 to 8 years old); 3 tablets (9-13 years old), 4 tablets (\>13 years old)
The population of interest consists of patients aged between \> 6 months to 59 years old diagnosed with uncomplicated falciparum malaria attending the study health clinic, and having given, or whose parents or legal guardians have given informed consent for study inclusion and assent in children as appropriate.
Council for International Organizations of Medical Sciences. International ethical guidelines for biomedical research involving human subjects. Bull Med Ethics. 2002 Oct;(182):17-23.
World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
Capillary blood (malaria blood film and filter paper)
Fe Esperanza Caridad J Espino, MD, PhD
Research Institute for Tropical Medicine
80 participants (actual enrollment reported by the registry).
First Submitted
June 30, 2023
First Posted
July 25, 2023
Study Start
January 2, 2017
Actual (reported)The Impact RTS,S/AS01 Vaccine in School Aged Children RTS,S/AS01 Malaria Vaccine in School Aged Children
Day 7-28
Number of Patients with Adequate Clinical and Parasitological Response (ACPR)
The number of patients with absence of parasitemia on day 28 irrespective of axillary temperature without previously meeting any of the criteria of Early Treatment Failure or Late Clinical Failure or Late Parasitological Failure.
Day 0-28
For Pf patients, primaquine at 0.75 mg base/kg body weight single dose will be given on Day 3 for Pf patients; For Pv patients primaquine will be withheld for 28 days and will be given after Day 28 follow-up, at 0.25 mg base/kg per day for 14 days.
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Primary Completion
December 28, 2018
Actual (reported)Study Completion
December 28, 2018
Actual (reported)Last Updated
July 25, 2023
Record last verified: 2023-07
The IPD will be shared with Data Transfer Agreement and IRB Approval
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Source: ClinicalTrials.gov.
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