Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Trial to Determine the Efficacy and Safety of Coartemether and Artekin for the Treatment of Acute Falciparum and Vivax Malaria in Timika, Papua
Brief Summary: This open randomized, parallel group, 6 week trial in two rural outpatient clinics will compare the safety and efficacy of a six dose coartemether regimen with 3 dose artekin regimen for the treatment of acute, uncomplicated falciparum and vivax malaria in adults and children (\>10kg).


Options:
A: Inclusion Criteria:

* microscopically confirmed acute uncomplicated falciparum malaria;
* temperature at screening 37.50C or more or history of fever 24 preceding enrollment;
* willingness to comply with follow up schedule;
* written informed consent by accompanying parent or guardian

Exclusion Criteria:

* features of severe malaria or danger signs of malaria
* known intolerance or allergy to any of the study medications
* known treatment with any of the study medications in the month preceding enrollment
* serious underlying disease that may mask outcome assessment
B: Inclusion Criteria:

* Age: 5 - 60 years old
* Fever (axillary temperature equal or higher than 37,5 °C) or history of fever in the previous 24 hours
* Monoinfection with P. falciparum, with parasitic density between 1,000 and 200,000 par/µl
* Informed consent provided by patient or parent or legal tutor

  • Exclusion criteria:
* Mixed malaria infection
* Pregnancy or breastfeeding to child ≤ 6 months of age
* One or more danger signs or any sign of severe or complicated malaria
* A concomitant severe disease
* History of treatment with mefloquine in the last 60 days or chloroquine, primaquine or quinine within the 14 days before the present episode
* History of neuropsychiatric disease
* History of hypersensitivity reactions to artemisinins or mefloquine
* History of splenectomy
C: Inclusion Criteria:

* Age 6 months to 10 years
* Body weight \>5 kg
* Uncomplicated P. falciparum malaria
* Mono-infection with P. falciparum
* Asexual parasite density 2,000 to 200,000 parasites/µl
* Haemoglobin ≥7.0 g/dL
* Axillary temperature ≥37.5ºC or history of fever in preceding 24 hr
* Ability to tolerate oral therapy
* Residence in study area

Exclusion Criteria:

* Haemoglobin \<7.0 g/dL
* Leucocyte count: \>15,000/µL
* G6PD deficiency
* Mixed malaria infections
* Danger signs (unable to drink; repeated vomiting; recent history of convulsions; lethargic or unconscious state; unable to stand up or to sit) and signs of severe malaria as defined by WHO
* Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
* Concomitant disease masking assessment of response, e.g. known or suspected hearing impairments
D: Inclusion Criteria:

* Male and female patients at least one 1year of age and weighing more than 10kg.
* Microscopic confirmation of P. falciparum and /or P.vivax infection (any parasitaemia).
* Fever (axillary temperature \>37.5C) or history of fever in the last 48 hours.
* Able to participate in the trial and comply with the clinical trial protocol
* Written informed consent to participate in trial; verbal consent in presence of literate witness is required for illiterate patients, and written consent from parents/guardian for children below age of consent

Exclusion Criteria:

* Pregnancy or lactation
* Inability to tolerate oral treatment
* Signs/symptoms indicative of severe/complicated malaria or warning signs requiring parenteral treatment (See Appendix II)
* Known hypersensitivity or allergy to artemisinin derivatives
* Serious underlying disease (cardiac, renal or hepatic)
* Parasitaemia \>4%

Answer: D