Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of the Efficacy and Safety of Primaquine for Clearance of Gametocytes in Uncomplicated Falciparum Malaria in Uganda
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of lower doses of primaquine compared to the dose recommended by the WHO for reducing P. falciparum gametocytes in the infected human host to prevent transmission of falciparum malaria to the anopheles mosquito vector.


Options:
A: Inclusion Criteria:

* presentation at basic health unit with suspected clinical malaria
* mono-infection infection with P. falciparum confirmed by microscopy
* over 2 years of age (no upper age restriction)
* weight over 5 kg (no upper weight restriction)
* if of child bearing age then non-pregnant and willing to remain so for the duration of the study
* greater than 1 asexual parasite per 10 fields
* understands and is willing to sign the consent form
* a resident in the study site willing to collaborate for a full period of follow-up
* no signs of severe malaria

Exclusion Criteria:

* other serious disease (e.g., cardiac, renal or hepatic)
* in women of child bearing age, pregnancy
* allergy to any of the study drugs or related compounds
* reports to have used any malaria drugs in the last 21 days
* other species of malaria seen
* signs of severe malaria
B: Inclusion Criteria:

* Age \>/= 1 year and \</= 10 years
* Weight over 10kg
* Fever \>38 degrees C (tympanic) or history of fever in the last 24 hours
* P. falciparum parasitaemia \<500 000/µl
* Normal G6PD enzyme function

Exclusion Criteria:

* Enrolled in another study
* Evidence of severe illness/ danger signs
* Known allergy to study medications
* Haemoglobin \< 8g/dL)
* Started menstruation
* Pregnancy or breastfeeding
* Primaquine taken within the last 4 weeks
* Blood transfusion within the last 90 days
* Non-falciparum malaria co-infection
C: Inclusion Criteria:

1. Otherwise healthy volunteer, 18-65 years of age, eligible for care at an RCAF facility, and at risk for contracting malaria
2. Able to provide informed consent
3. Likely to reside in endemic area for the duration of the study
4. Available for follow-up for anticipated study duration, and agrees to participate for the duration of the study
5. Authorized by local commander to participate in the study if on active duty

Exclusion Criteria:

1. History of allergic reaction or contraindication to DHA or piperaquine
2. Significant acute comorbidity requiring urgent medical intervention
3. Pregnant or lactating female, or a female of childbearing age who does not agree to use a highly effective method of birth control during the study
4. Clinically significant abnormal EKG, including a QTc interval \> 500 ms.
5. Judged by the investigator to be otherwise unsuitable for study participation
D: Inclusion criteria:

* Acute, uncomplicated P.falciparum malaria, microscopically confirmed infection.
* Temperature at screening of 37.5oC or over or confirmed history of fever within previous 24-hours.
* Weight 7.5kg or over , no upper weight limit.
* Screening haemoglobin (Hb) of 7g/dl, or more or haematocrit of 25% or over(if Hb not available at screening).
* Willingness to comply with the study visits and procedures, as outlined in the informed consent form.
* Written or oral witnessed consent obtained from subject, parent or guardian.
* Assent is given by a child aged 12 to \<18years, in addition to the consent of their parent or guardian.

Exclusion criteria:

* Features of severe/complicated falciparum malaria.
* Hypersensitivity to active substances (chlorproguanil, dapsone, artesunate), or excipients of the investigational products.
* Known allergy to biguanides, sulphones, sulphonamides or artemisinin derived products.
* Known history of G6PD deficiency.
* Infants with a history of hyperbilirubinaemia during the neonatal period.
* Evidence of any concomitant infection at the time of presentation (including P. vivax, P. ovale and P. malariae).
* Use of concomitant medications that may induce haemolysis or haemolytic anaemia from the WHO (World Health Organization) list of essential drugs.
* Any other underlying disease that may compromise the diagnosis and the evaluation of the response to the study medication (including clinical symptoms of immunosuppression, tuberculosis, bacterial infection; cardiac or pulmonary disease).
* Malnutrition, defined as a child whose weight-for-height is below -3 standard deviations or less than 70% of the median of the NCHS/WHO normalised reference values
* Treatment within the past three months with mefloquine or mefloquine-sulphadoxine-pyrimethamine; twenty-eight days with sulphadoxine/pyrimethamine, sulfalene/pyrimethamine, lumefantrine or artemether/lumefantrine, amodiaquine, atovaquone or atovaquone/proguanil, halofantrine; 14-days with chlorproguanil/dapsone, or 7-days with quinine (full course), proguanil, artemisinin, tetracycline doxycycline or clindamycin.
* Positive sulphadoxine/pyrimethamine urine screen for 'unknown' antimalarial drug use in prior 28-days.
* Use of an investigational drug within 30 days or 5 half-lives whichever is the longer.
* Previous participation in this study.
* Female subjects of child-bearing potential who have had a positive pregnancy test at enrolment, or do not give their consent to take a pregnancy test.
* Female subjects who will be breast-feeding an infant for the duration of the study.

Answer: B