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:

* ≥ 6 months old
* Microscopic diagnosis of Plasmodium vivax malaria mono-infection
* Participant or parent/guardian is willing and able to give informed consent for participation in the study
* Able (in the Investigators opinion) and willing to comply with all study requirements.

Exclusion Criteria:

* Severe malaria
* History of allergy or adverse reaction to artesunate, piperaquine, chloroquine, or primaquine
* Blood transfusion in the past 3 months
* G6PD deficiency by rapid test
* Hematocrit ≤ 25%
* Pregnancy at the time of screening
* Breastfeeding an infant \< 6 months old
* Presence of any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study
B: 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.
C: Inclusion Criteria:

* Lactating women aged 18 years and older who are breast feeding one infant aged more than 28 days.
* G6PD normal
* History of proven P.vivax malaria that has not been treated with primaquine
* Willingness and ability to comply with the study protocol for the duration of the trial
* Written informed consent provided

Exclusion Criteria:

* Known hypersensitivity to primaquine, defined as history of erythroderma/other severe cutaneous reaction, angioedema or anaphylaxis
* Glucose-6-phosphate-dehydrogenase (G6PD) deficiency in mother
* Glucose-6-phosphate-dehydrogenase (G6PD) deficiency in infant
* Pregnancy (urine test for HCG to be performed on any woman of child bearing age unless menstruating)
* Blood smear positive for malaria at the time of enrolment
* Presence of intercurrent illness or any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study
* Hematocrit (HCT) \<25% in the mother or \<33% in the infant
* Use of medications other than antipyretics in the past 7 days or Chloroquine in the past 2 months.
* Use of primaquine since most recent malaria episode.
D: 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

Answer: D