Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of a Malaria Transmission Target Strategy Based on the Periodic Treatment With Sulfadoxine-Pyrimethamine vs. Early Case Management
Brief Summary: Recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (IPT) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being any rebound in the subsequent year. However, in countries such as Mali, where malaria is highly seasonal and prevalent in older children, IPT in infants may not be the optimum way in which to use antimalarial drugs to prevent malaria. An alternative approach is to give intermittent preventive treatment to children at risk just during the rainy season. Here we propose (i) to evaluate the impact of two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the incidence of malaria disease in children of 6 months to 10 years in an area of seasonal transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo response of P. falciparum to SP; (iii) to assess the potential rebound effect of this strategy on the subsequent transmission season after the cessation. Children 6 months-10 years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks interval or no IPT during the transmission season and will followed up for 12 months. Subjects will be also followed during the subsequent transmission season to assess possible rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to assess the in vivo response during both periods.


Options:
A: Inclusion Criteria:

* child attending routine vaccination services for second or third dose of diptheria/pertussis/tetanus vaccinations (aged approximately two and three months, respectively) or for measles vaccination (aged approximately 9 months)

Exclusion Criteria:

* sensitivity to sulfadoxine-pyrimethamine or other sulfur-containing drugs
B: * INCLUSION CRITERIA (Parasite Recrudescence Study):

  1. Age 2 to 65 years, inclusive
  2. Uncomplicated P. falciparum malaria
  3. Temperature greater than or equal to 37.5 degrees Celsius or history of fever within the last 24 h
  4. P. falciparum asexual parasite density less than or equal to 200,000/microL
  5. Willingness to allow the storage of blood samples collected as part of the study
  6. Willingness and ability of patients/guardians to comply with the protocol for the duration of the study.

EXCLUSION CRITERIA (Parasite Recrudescence Study):

1. Severe malaria: diminished consciousness, respiratory distress, severe prostration, anuria, jaundice, hemoglobinuria, repetitive vomiting, or cessation of eating and drinking
2. Non-malaria etiology of febrile illness (e.g., respiratory tract infection) evident by history and physical examination
3. Hematocrit \<25%
4. Treatment of present symptoms with an antimalarial drug within the previous 7 days
5. Pregnancy or breastfeeding
6. History of allergy or known contraindication to artemisinins or MQ
7. Splenectomy
8. P. vivax parasitemia

INCLUSION CRITERIA (Peripheral Blood Collection Study):

1. Healthy-appearing adults greater than or equal to 18 years old
2. Residence in Pursat province
3. Willingness to participate in the study as evidenced by informed consent

EXCLUSION CRITERIA (Peripheral Blood Collection Study):

1. Pregnancy
2. Hematocrit \<25%
C: Inclusion Criteria:

* Age 6 months to 10 years
* Agree to seek initial medical care for all medical illness in the study clinic during the study period
* Written informed consent by a parent or legal garden,
* No plan to travel for a long time during the study period.

Exclusion Criteria:

* History of allergy to sulfa drugs or Sulfadoxine-pyrimethamine
* Chronic illness or symptomatic malaria at the time of enrollment
D: Inclusion Criteria:

* Children between the ages of 3-59 months resident in the selected communities
* Children likely to be available for follow-up for 18 months
* Consent by parent/guardian of child

Exclusion Criteria:

* Chronic illness
* History of hypersensitivity to any of the study drugs

Answer: C