Please select the eligibility criteria that correspond to the clinical trial below.
Title: Mass-Drug Administration With a Gametocytocidal Drug Combination, a Model for a Transmission Blocking Vaccine
Brief Summary: In the 1950s, the WHO included mass drug administration (MDA) with antimalarial drugs as a tool for malaria control in 'exceptional conditions when conventional control strategies have failed'. Subsequently, MDA has received little attention until the introduction of artemisinin based combination therapy (ACT). The principle aim of MDA is to interrupt malaria transmission by clearing the population of sexual stage parasites, gametocytes, prior to the transmission season. Gametocytes are essential for propagation of the disease and elimination of gametocytes will result in a reduction in malaria transmission. As a consequence, a successful MDA will reduce the burden of disease in a population and is expected to have little influence on the development of protective immunity in areas of low transmission intensity. In Africa, only one large scale MDA study was conducted in the last 10 years. That study, conducted in The Gambia using sulphadoxine-pyrimethamine (SP) plus a single dose of artesunate (AS), failed to show a significant impact of MDA on malaria transmission. Possible reasons for this failure are the limited impact of the drug regimen (a single dose of AS) on malaria transmission, the incomplete coverage, the relatively high transmission intensity in the area and the migration of individuals between villages. Here, we propose to conduct an MDA study in an area of very low malaria transmission intensity in Tanzania. We use the highly active drug combination SP+AS (3 days) followed by a single dose of primaquine..


Options:
A: 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.
B: Inclusion Criteria:

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

Exclusion Criteria:

* severe anemia
* pregnancy
C: 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
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: B