The patients will take Eurartesim® (DHA/PQP) with a dose regimen of one administration every 24 hours over a period of three days, i.e. at Day 1, then after 24 hours (Day 2) and after 48 hours (Day 3) from the first administration. The dose will be based on body weight. Two strengths of Eurartesim® will be provided for dosing in children and adults: 20/160mg and 40/320mg of DHA and PQP respectively. Body weight (kg) Daily dose (mg) Number of tablets per dose 20/160mg DHA/PQ 40/320mg DHA/PQ 5 to <7 10 mg DHA and 80 mg PQP ½ tablet 7 to <13 20 mg DHA and 160 mg PQP 1 tablet 13 to < 24 40 mg DHA and 320 mg PQP 1 tablet 24 to < 36 80 mg DHA and 640 mg PQP 2 tablets 36 to < 75 120 mg DHA and 960 mg PQP 3 tablets 75 to < 100 160 mg DHA and 1280 mg PQP 4 tablets > 100.

Malaria

Dihydroartemisinin and piperaquine

Nouna Research Centre

Nanoro Health Research Centre

INDEPTH Network

Dodowa Health ReseaRCH Centre

Kintampo Health Research Centre

Mnahica Health Research Centre

Rufigi Research Centre

Introduction of Eurartesim® in Burkina Faso, Mozambique, Ghana and Tanzania

Observational Study to Evaluate the Clinical Safety After Introduction of the Fixed Dose Artemisinin-based Combination Therapy Eurartesim® (Dihydroartemisinin/Piperaquine [Dha/Pqp]) in Public Health Districts in Sub-Saharan Africa.

• Clinical safety will be determined by analysis of the number of adverse events (frequency, intensity, action taken, outcome) captured during their follow up contacts on Day 5 (±2 days) after starting the treatment with Eurartesim® as well as those identified in the referring hospitals or through adverse events spontaneously reported by the patient detected at the health facility within 28 days after the first medication intake.

In case of an AESI confirmed by the study doctor, the sponsor shall be informed within 24 hours, even if the event does not satisfy any condition of seriousness. Notification will occur through the use of an ad hoc AESI form. AESIs can be related to:
Cardio-toxicity i.e. prolonged QT
Neurotoxicity/seizures
Cutaneous reactions/phototoxicity

In predefined centres having the capability to store plasma samples, all the 1000 subset will also perform a blood drawing for PQ plasma concentration at Day 1 (before drug administration), twice at Day 3 (before and 3-4 after the last drug administration) as well as on Day 7.

Ministry of Health, Ghana

Ifakara Health Research and Development Centre

Ministry of Health, Burkina Faso

Centro de Investigacao em Saude de Manhica

The infected individuals were treated with the standard chloroquine (CQ)+primaquine(PQ) regimen to malaria caused by Plasmodium vivax.
Chloroquine (tablet containing 150mg of base) - it was given on days 0 (10mg/kg), 1 (7.5mg/kg) and 2 (7.5mg/kg). Total dose, 25 mg base/kg.
Primaquine - it was given once a day (0.5 mg/kg) for seven days, starting on day 0 of CQ treatment. Total dose, 3.5mg/kg The medications were administered under direct observation and the patient was monitored for vomiting for 60 minutes.

The infected individuals were initially treated with chloroquine (CQ) alone and the primaquine(PQ) was introduced on day 28.
Chloroquine (tablet containing 150mg of base) - it was given on days 0 (10mg/kg), 1 (7.5mg/kg) and 2 (7.5mg/kg). Total dose, 25 mg base/kg.
Primaquine - it was given once a day (0.5 mg/kg) for seven days, starting on day 28 of CQ treatment. Total dose, 3.5mg/kg.
The medications were administered under direct observation and the patient was monitored for vomiting for 60 minutes.

Malaria, Vivax

10mg/kg on day 0 and 7.5mg/kg on days 1 and 2. Total dose, 25 mg base/kg. Tablet containing 150mg of base.

Chloroquine

0.5 mg/kg once a day, for seven days. Total dose, 3.5mg/kg.

Primaquine

Oswaldo Cruz Foundation

Institute of Biomedical Sciences, University of Sao Paulo

Efficacy of Chloroquine (CQ) Alone Compared to Concomitant CQ and Primaquine for Plasmodium Vivax Infection

Efficacy of Chloroquine (CQ) Alone Compared to Concomitant CQ and Primaquine (PQ) for the Treatment of Uncomplicated Plasmodium Vivax Infection

danger signs or severe malaria on day 1, 2 or 3 in the presence of parasitaemia OR parasitaemia on day 2 higher than on day 0 OR parasitaemia on day 3 with axillary temperature ≥ 37.5 ºC OR parasitaemia on day 3 ≥ 25% of count on day 0

danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 28 OR parasitaemia on any day between day 4 and day 28 with axillary temperature ≥ 37.5 ºC (or history of fever) in patients who did not previously meet any of the criteria of early treatment failure

presence of parasitaemia on any day between day 7 and day 28 with axillary temperature < 37.5 ºC in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure

Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication.

Any untoward and unintended responses to a medicinal product related to any dose judged by either the reporting medically qualified professional or the sponsor as having a reasonable suspected causal relationship to the study medication.

University of Sao Paulo

Plasmodium Vivax

efficacy of chloroquine for the treatment of Plasmodium vivax infections

Chu R Cam

Evaluating the Efficacy of Chloroquine for the Treatment of Plasmodium Vivax Infections in Central Vietnam

This outcome will be measured at day42 of follow-up. Treatment outcomes such as ACPR, early or late clinical failures are defined following WHO guidelines;

Individual and mean IC50 and IC90 values will be computed for each drug using the IVART tool available online (http://www.wwarn.org/tools-resources/toolkit/analyse/ivart)

asexual parasite forms will be detected by qPCR. This outcome will be measured for each sampling time point.

All parasites at day0 will be genotyped and processed by whole genome sequencing to identify molecular markers of CHL resistance. The same analysis will be done for any P. vivax recurrence occurring during the 42-day follow-up.

All patients will be tested for G6PD deficiency by a rapid test (CareStart) before given the radical cure treatment with primaquine.

sexual parasite forms will be detected by RT-qPCR. This outcome will be measured for each sampling time point.

spotted/qusma

Introduction of Eurartesim® in Burkina Faso, Mozambique, Ghana and Tanzania

Efficacy of Chloroquine (CQ) Alone Compared to Concomitant CQ and Primaquine for Plasmodium Vivax Infection

Evaluating the Efficacy of Chloroquine for the Treatment of Plasmodium Vivax Infections in Central Vietnam

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