Efficacy and Safety of Artemether-lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria and Chloroquine for Plasmodium Vivax in the Philippines From 2013-2014

2003-25-12_2013

An antimalarial drug efficacy trial was conducted for artemether-lumefantrine (AL) and chloroquine (CQ) in the three (3) municipalities (Bataraza, Brookes and Rizal) of Palawan. Study subjects are febrile individuals between \> 6 months old and 59 years old with confirmed uncomplicated P. falciparum or P. vivax infections. Patients with P. falciparum was treated with Artemether-lumefantrine administered 3 days (Days 0, 1 and 2) according to body weight. Primaquine at 0.75 mg base/kg body weight single dose was given on Day 3. For Plasmodium vivax patients chloroquine were administered according to body weight at a total dose of 25 mg/kg over 3 days (10 mg/kg on Day 0; 10 mg/kg on Day 1 and 5 mg/kg on Day 2), and primaquine following the National Treatment Guidelines. During the period that this report covers, 84 and 75 patients met the inclusion criteria for Pf and Pv respectively. Clinical and parasitological parameters were monitored over a 28-day follow-up period for both drugs. The presence of only 1 Late Clinical Failure (LCF) of P. falciparum parasitemia out of 84 enrolled patients and 2 Late Parasitological Failure (LPF) of P. vivax patients out of 75 enrolled patients within the 28 days follow up suggest that both drugs are still efficacious.

2013-05-01

2014-12-30

2014-12-30

Completed

159

Inclusion Criteria: * Above 6 months old to 59 years old; * Mono-infection with P. falciparum (1000-100 000 asexual forms per µl) and P. vivax (≥250/ul) * Axillary temperature ≥37.5 °C or oral/rectal temperature of ≥38 °C; * Glucose-6-dehydrogenase (G6PD) test normal for vivax patients if available * Ability to swallow medication; * Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; * Informed consent from the patient or from a parent or legal guardian in the case of children less than 18 years old; * Informed assent from any minor participant aged 12 - 17 years; and * Consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under 18 years old. Exclusion Criteria: * Presence of general danger signs among children \<5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions * Mixed Plasmodium species; * Presence of severe malnutrition * Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, HIV/AIDS) * History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Capillary blood (malaria blood film and filter paper)'}, 'enrollmentInfo': {'count': 159, 'type': 'ACTUAL'}}

2023-07-21