Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of the Efficacy and Safety of Two ACTs Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria in North Sumatera, Indonesia: 1 Year Followup
Brief Summary: This randomized clinical trial will be conducted in subjects with uncomplicated Plasmodium vivax malaria during November 2010 to March 2012. The aim of the study is to compare the efficacy and safety of artesunate-amodiaquine plus primaquine (AS-AQ + PQ) and dihydroartemisinin-piperaquine plus primaquine (DHP + PQ) in uncomplicated vivax malaria. The significance of the study is to find alternative drug for treating patients with vivax malaria in case the standard treatment is not available or become resistance. This study will give thorough information about the efficacy and safety of 2 artemisinin-based combination therapies (ACTs) in combination with primaquine. It will also inform the Indonesian Ministry of Health on their suggested policies for radical cure of vivax malaria, and provides evidence based treatment options for chloroquine resistant vivax malaria. This study will also provide information about prevalence of glucose-6-phosphate dehydrogenase (G6PD) deficiency and G6PD variants in North Sumatera population.


Options:
A: Inclusion Criteria:

* Both sex
* Age \> 1 year
* Fever (axillary temp ≥ 37.5oC) or history of fever during the preceding 48 hours
* Uncomplicated Plasmodium vivax confirm by microscopic examination
* Asexual parasite ≥ 250/µL blood
* Absence of clinical condition that need hospitalization
* No history of allergy to antimalarial drug
* Not consuming antibiotic with antimalarial activity

Exclusion Criteria:

* Clinical features of severe malaria
* Severe malnutrition
* Recurrent vomiting
* Concomitant infection
* Pregnant (test for β-HCG in women of child bearing age)
* Lactating mother
* Move out from study area
* Not eligible to follow up during study period
B: Inclusion criteria

* Age over 6 months and
* Weight ≥ 5 kg, and
* Slide-confirmed infection with Plasmodium falciparum (including mixed infections), and
* Asexual parasite density between 500 and 200,000/µl of blood, and
* Informed consent from a parent or guardian aged at least 18 years.

Exclusion criteria

* General danger signs according to the WHO definition or
* Signs of severe/complicated malaria according to the WHO definition or
* Severe anaemia (haemoglobin \< 5 g/dL), or
* Known history of hypersensitivity to any of the study drugs, or
* Severe malnutrition (as defined by a weight-for-height below 70% of median and/or symmetrical oedemas involving at least the feet), or
* Concomitant febrile illness due to causes other than malaria with the potential to confound study outcome (measles, acute lower tract respiratory infection, otitis media, tonsillitis, abscesses, severe diarrhoea with dehydration, etc.; mild flu should not lead to exclusion) or
* History of psychiatric diseases, or
* Having received a full course treatment including MQ in the preceding 9 weeks or
* Having received any other antimalarials in the previous 48 hours.
C: Inclusion Criteria:

* permanent resident of the research area
* age \>1 years

Exclusion Criteria:

* severe anemia
* pregnancy
D: Inclusion Criteria:

* Patients diagnosed with P. vivax parasitaemia
* Patients over 3 years
* Patients with G6PD deficiency to a safety trial
* Patients without G6PD deficiency to all other groups.

Exclusion Criteria:

* Children under the age of three
* Pregnant / breast feeding women
* Patients with severe clinical anaemia \[Hb\<7g/dl\]
* Patients with P. falciparum
* Patients unavailable for the duration of study.
* Patients who have taken antimalarial drugs in the 2 weeks prior to consultation.
* Patients with concomitant infections or whose general health is considered too poor.

Answer: A