Please select the eligibility criteria that correspond to the clinical trial below.
Title: Intermittent Preventive Treatment (IPTi) for the Prevention of Malaria and Anaemia in PNG Infants
Brief Summary: In malaria-endemic areas, young children have an especially high risk of malaria morbidity and mortality. Malaria is estimated to cause up to 2 million deaths and 500 million clinical episodes in Africa alone. The bulk of disease in Africa and severe disease and deaths globally is due to P. falciparum. However, P. vivax is also responsible for a substantial disease burden in endemic regions outside Africa, where P. vivax may account for more than half of all malaria cases. Efforts to reduce this unacceptably high disease burden are hampered by the limited availability of affordable interventions. Following the cessation of large-scale vector control in highly endemic areas, malaria control efforts have centred on early diagnosis and treatment of clinical cases and reducing exposure through the use of insecticide-treated nets (ITNs). While ITNs have been shown to significantly reduce the burden of malaria additional effective interventions are urgently needed.

Several trials have shown that chemoprophylaxis given to children at weekly or fortnightly intervals reduces morbidity from malaria in a number of different settings and populations.

An alternative approach has been to use intermittent preventive therapy (IPT) involving the administration of a full therapeutic dose of antimalarials at regular intervals. This is logistically easier to deliver, and is less costly, and may reduce problems of promoting drug resistance associated with regular chemoprophylaxis. Intermittent administration of sulphadoxine-pyrimethamine (SP) during antenatal clinic visits was shown to be highly effective in reducing malaria and anaemia in pregnant women and improving infant birth weights. IPT in pregnancy (IPTp) is now recommended by WHO for endemic regions of Africa.


Options:
A: Inclusion Criteria:

* 3 months old living in the aera for the next 2 years, exlusive use of the study health facilities

Exclusion Criteria:

* Known chronic illness, e.g. TB, diabetes, renal failure severe malnutrition (weight-for-age (WAZ) \< 60% percentile) severe anaemia (Hb \< 5 g/dl), or permanent disability, that prevents or impedes study participation
B: Inclusion Criteria:

1. Age 4 -5 months
2. Confirmed HIV status of biological mother
3. Negative HIV DNA PCR test at time of enrollment for infants born to HIV-infected mothers
4. Infants born to HIV-infected mothers must be breastfeeding
5. Residency within 30km of the study clinic
6. Agreement to come to the study clinic for any febrile episode or other illness and avoid medications given outside the study protocol
7. Provision of informed consent by parent/guardian

Exclusion Criteria:

1. History of allergy or sensitivity to TS, SP, or DP
2. Active medical problem requiring in-patient evaluation at the time of screening
3. Intention of moving more that 30km from the study clinic during the follow-up period
4. Chronic medical condition (i.e. malignancy) requiring frequent medical attention
5. Living in the same household as a previously enrolled study participant
6. QTc interval \> 450 msec
7. Other clinically significant ECG abnormalities such as arrhythmia, ischemia, or evidence of heart failure
8. Family history of Long QT syndrome
9. Current use of drugs that prolong the QT interval
C: Inclusion Criteria:

* Permanent residence in the study area with no intention of leaving during the surveillance period.
* Obtention of informed consent.

Exclusion Criteria:

* Temporary residence in the study area.
* Absence of informed consent.
* Presence of a severe, chronic illness such as severe malnutrition (Kwashiorkor or marasmus) or AIDS, likely to interfere with evaluation of the trial results.
* A history of a previous, significant adverse reaction to either of the study drugs.
D: Inclusion Criteria:

* Presenting for Pentavalent 1 immunization
* Age 5 weeks to 16 weeks
* Parent or guardian currently resident in study catchment area
* Parent or guardian has given permission for their child to participate

Exclusion Criteria:

* Known allergy to any of the study drugs
* Current Cotrimoxazole prophylaxis
* Concomitant disease requiring hospitalization or transfusion
* Plans to be away from the study area for more than 6 months during the next year

Answer: A