Participants recruited that pass the inclusion and exclusion criteria

Malaria

Falciparum Malaria

Vivax Malaria

Three days according to body weight (Days 0, 1 and 2). Correct drug dosage will be determined using the dosing chart (in accordance with national treatment guidelines).

Arthemeter-lumefantrine

Chloroquine according to body weight as a total dose of 25mg base/kg over 3 days (10 mg base/kg on Day 0; 10 mg base/kg on Day 1 and 5 mg base/kg on Day 2). Primaquine will be withheld for 28 days. It will be given after Day 28 follow-up, at 0.25 mg base/kg per day for 14 days.

Chloroquine

TES Artemether-lumefantrine for Pf and Chloroquine (CQ) for Pv

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

Development of danger signs or severe malaria on day 1, day 2 or day 3 in the presence of parasitaemia; Parasitaemia on day 2 higher than day 0 count irrespective of axillary temperature; Parasitaemia on day 3 with axillary temperature ≥37.5 degree celsius; Parasitaemia on day 3 ≥25% of count on day 0.

Development of danger signs or severe malaria on any day from day 4 to day 28 in the presence of parasitaemia, without previously meeting any of the criteria of Early Treatment Failure; Presence of parasitaemia and axillary temperature ≥37.5 degree celsius (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.

Absence of parasitaemia 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.

Fe Esperanza J. Espino, MD, PhD

Principal Investigator, Head of Parasitology Department

Research Institute for Tropical Medicine, Philippines

World Health Organization

Arthemeter-lumefantrine (ART-LUM) is an antimalaria drug manufactured as fixed combination tablets, each containing 20 mg of artemether and 120 mg of lumefantrine. ART-LUM was administrated according to body weight as six consecutive doses: The first dose at diagnosis and the second dose eight hours later, 0- 24-48 hours

Artesunate mefloquine (ASMQ) is an antimalaria drug administered as a combination of artesunate, 4 mg/kg/day, with mefloquine, 8 mg/kg/day orally once a day for 3 days or three times, at an interval of 24 hours (0 h - 24 h - 48 h).

Dihydroartemisinin piperaquine (DHA-PQ ) is an antimalaria drug administered as a combination of dihydroartemisinin, 2.5 mg per kg, with piperaquine phosphate, 20mg per kg daily for 3 days or three times, at an interval of 24 hours

Oral paracetamol is administered at of 50mg/kg body weight per day in three divided doses for fever exceeding 37.5oC.

amoxicillin is an antibiotic administered at 50mg per kg body weight per day for seven days in the event of concomitant bacterial infection, absent on day 0 but present during the follow up.

Quinine is an antimalarial recommended by the WHO and NMCP to be used as second line treatment for malaria. In this study, for cases of treatment failure with the artemisinin based combination therapies, quinine sulphate is administered as a second line or rescue drug at a dose of 25mg base per kg body weight per day in three divided doses for five days. The participant is then classified as ETF or LTF and excluded from the study.

Drug Resistant Malaria Due to Plasmodium Falciparum

Randomization codes were computer-generated by an offsite investigator and provided to a study nurse responsible for treatment allocation. All other study personnel were blinded to the treatment assignments, and patients were not informed of their treatment regimen. Participants from Group 1: AL, Group 2 : DHAP, Group3 : ASMQ were also given appointment card for days 1, 2, 3, 7, 14, 21, 28, 35 and 42 for clinical examination and blood smears. Blood was taken on filter paper on each of these visits.

Artequin® is an antimalarial drug presented as infant co-formulation of two separate drugs

Artesunate mefloquine

Malacur®. is an antimalarial drug presentad as co-formulation of two separate drugs

Dihydroartemisinin piperaquine

Paracetamol, is an antipyretic drug, presented as tablets or syrup in infants formulation

Paracetamol

Amoxicillin is an antibiotic with no reported activity on plasmodium

Amoxicillin

quinine sulphate is an antimalaria drug administered as a second line or rescue drug

Quinine

CDC Hospital

Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa

Assessment of Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa

The primary endpoint was the 28-day and 42-day cure rates and was defined as proportion of patients with adequate clinical and parasitological response (ACPR) after 28 and 42 days of follow-up. Absence of parasitemia until day 28 and day 42 irrespective of axillary temperature was categorized as an adequate clinical and parasitologic response (ACPR). Secondary endpoints were early treatment failure (ETF), late clinical failure (LCF), late parasitological failure (LPF), adverse events (clinical and laboratory abnormalities), anaemia (Hematocrit < 30%), clearance rate of fever and parasitaemia, and gametocyte

The ability of the drug to restore hemoglobin level back to normal

The ability of the drug to completely eliminate plasmodium in the blood stream including participant without symptoms of fever

blood sample from patients with parasitaemia at any day of follow-up are analysed by PCR to evaluated the genetic profile of the MSP1 and MSP2

quinine/diare

TES Artemether-lumefantrine for Pf and Chloroquine (CQ) for Pv

Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa

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