Please select the eligibility criteria that correspond to the clinical trial below.
Title: Drug Options for Intermittent Preventive Treatment for Malaria in Infants in an Area With High Resistance to Sulfadoxine/Pyrimethamine: an Evaluation of Short and Long-acting Antimalarial Drugs
Brief Summary: Malaria and anaemia are major causes of morbidity and mortality in children in sub-Saharan Africa. Administration of three courses of sulfadoxine/pyrimethamine (SP) as intermittent preventive treatment (IPTi) to infants when they receive EPI vaccines reduced the incidence of malaria and anaemia in infants in an area with low SP resistance, low transmission pressure and high bednet use. However, it is not clear whether this observation can be generalised to areas with high transmission and high SP resistance. The mechanism of the protective effect of IPTi is unclear. There is an urgent need to identify other anti-malarial drugs that could be used for IPTi instead of SP.

This study objectives are:

1. Identification of a drug that could be used safely and effectively for IPTi instead of SP in areas, such as north eastern Tanzania, where there is a high level of resistance to SP and amodiaquine.
2. Determination of whether a short acting antimalarial drug (Lapdap) is as effective as a long acting drug (mefloquine) when used for IPTi.
3. Investigation of the effect of the intensity of transmission on the requirements for a long or short acting drug for IPTi.
4. Assessment of the effect of IPTi on the development of clinical immunity in children in low and high transmission areas.

A randomised trial with four treatment regimes is proposed which will be conducted in two different transmission settings. The four treatment regimens are as follows: (1) placebo; (2) mefloquine; (3) Lapdap; (4) SP. All medications will be given at the time of immunisation with DPT/polio 2, DPT/polio 3, and measles vaccines. The study will involve 1280 infants in a high endemic area and 2440 infants in a low endemic area, in Tanzania.The primary outcome is the incidence of clinical malaria.


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:

* 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.
C: Inclusion Criteria:

1. Viable pregnancy assessed by Doppler
2. Gestational age 16 to 32 weeks (inclusive) by fundal height
3. No history of IPTp use during this pregnancy
4. Willing to participate and complete the study schedule
5. Willing to sign or thumb print informed consent
6. Resident of study area and intending to stay in the area for the duration of the follow-up
7. Willing to deliver in the labor ward of the study clinic or hospital
8. HIV negative at enrolment

Exclusion Criteria:

1. HIV positive or unknown
2. Residence outside study area or planning to move out in the 12 months following enrolment
3. High risk pregnancy, including any pre-existing illness likely to cause complication of pregnancy (hypertension, diabetes, asthma, epilepsy, renal disease, liver disease, fistula repair, leg or spine deformity)
4. Severe anemia requiring blood transfusion (Hb ≤ 7.0 g/dL) at enrolment
5. Known allergy or previous adverse reaction to any of the study drugs
6. Unable to give informed consent (for example due to mental disability)
7. Previous inclusion in the same study
8. Gestational age \>32 weeks
9. Previous IPTp during the current pregnancy
10. Participating in other malaria intervention studies
11. Known or suspected cardiac disease
12. Patients taking drugs in any of the following classes: antiarrhythmic agents, neuroleptics, macrolides, and certain antimalarial drugs such as mefloquine, chloroquine, halofantrine and lumefantrine.
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: B