Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-blind, Randomised, Placebo-controlled Trial to Measure the Potential of Intermittent Treatment With Artesunate Plus Sulphadoxine/Pyrimethamine (SP) to Reduce the Malaria Burden in Sub-Saharan Africa
Brief Summary: In countries of the Sahel and sub-Sahel, malaria transmission is highly seasonal with nearly all infections occurring during a few months of the year. However, mortality and morbidity from malaria may be high during this period, especially in young children who are the group most at risk.

Intermittent preventative treatment (IPT) is a new approach to the prevention of malaria in this situation. IPT involves the administration of an anti-malarial to children at risk for malaria at fixed times, even if they are not infected. To investigate how effective this approach might be in Senegal, a trial has been undertaken in which 1136 children aged 6 weeks to 59 months were given a single dose of sulfadoxine pyrimethamine and artesunate on three occasions during a three-month rainy season and the incidence of clinical malaria in these children was compared with that in a group of children who received placebo. Additional observations were made on the incidence of side effects in children in the two groups and on the impact of IPT in children (IPTc) on markers of drug resistance in children whose blood films were positive for Plasmodium falciparum.


Options:
A: Inclusion Criteria:

* Children, aged 12 - 36 months, both sexes
* Absence of major systemic illnesses (as assessed by medical doctor upon initial full clinical assessment)
* Registered in DSS Taabo and anticipated residence in the study area for at least 1 year
* No severe anaemia, i.e. Hb ≥70 g/L in infants, as assessed by a Coulter Counter device
* No known or reported hypersensitivity to sulfadoxine-pyrimethamine, amodiaquine
* No known or reported history of significant chronic illness
* Written informed consent of parents or legal guardian

Exclusion Criteria:

* severe anaemia, i.e. Hb ≥70 g/L in infants, as assessed by a Coulter Counter device
* major systemic illnesses (as assessed by medical doctor upon initial full clinical assessment)
* known or reported hypersensitivity to albendazole, sulfadoxine-pyrimethamine, amodiaquine
* known or reported history of significant chronic illness
B: Inclusion Criteria:

* Ages 6 weeks to 59 months
* Residence in the study area
* Informed consent

Exclusion Criteria:

* Known allergy to study drugs
* Serious underlying illness
C: Inclusion Criteria:

1. Age between 3 months and 59 months at enrolment.
2. Informed consent obtained from parents or legal guardians.
3. No current participation in another malaria intervention trial
4. Permanent residence in the study area with no intention of leaving during the surveillance period.

Exclusion Criteria:

1. Previous adverse reaction to treatment with SP, amodiaquine or Coartem. If this is unknown, then a history of allergic reaction to any drug.
2. Temporary residence in the study area
3. Lack of informed consent
4. Presence of a severe, chronic illness such as severe malnutrition or AIDS, likely to interfere with evaluation of the trial results.
D: Inclusion Criteria:

* All infants attending EPI clinics at the 12 study health facilities for first vaccinations. Infants who live within the catchment area of the study health facility and are less than 3 months of age at the time of DPT and Polio 1 vaccination will be eligible for inclusion in the study.

Exclusion Criteria:

* Infants having any of the following conditions will be excluded: (1) history of allergy to study drugs; (2) history of convulsions; (3) clinical features of severe malnutrition or chronic illness including infants with signs of AIDS \[HIV prevalence in women of reproductive age in the study area was 11.5% in 1999\]39 (4) plans to leave the study area before 12 months of age.(5) weighs \<4.5 kgs (6) caretaker declines to give consent.

Answer: B