Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria
Brief Summary: Malaria is the most important human parasitic disease and is responsible of high morbidity and mortality in resource-poor countries. Pregnant women, who are a high-risk group, are almost always excluded from clinical trials; thus, the investigators lack sufficient information on the safety and efficacy of most antimalarials in pregnancy. The recommendation of the World Health Organization to use artemisinin combination therapy (ACT) in the 2nd and 3rd trimester is already implemented in several African countries, however documentation of their efficacy and safety in pregnancy is still limited. Thus, the investigators propose to evaluate the efficacy and safety of 4 ACT(artemether-lumefantrine, amodiaquine-artesunate, mefloquine-artesunate and dihydroartemisinin-piperaquine), when used to treat pregnant women with P. falciparum malaria; the results will help to recommend the optimal therapy for this high-risk group in Africa.


Options:
A: Inclusion Criteria:

Trial 1:

* Permanent resident in the area
* Gestational age at the first antenatal visit ≤ 28 weeks
* Signed informed consent
* Agreement to deliver in the study site's maternity(ies) wards

Trial 2:

* Permanent resident in the area.
* Gestational age at the first antenatal visit ≤ 28 weeks
* HIV seropositive (after voluntary counseling and testing)
* Indication to receive CTX prophylaxis (according to the national guidelines)
* Signed informed consent
* Agreement to deliver in the study site's maternity(ies) wards.

Exclusion Criteria:

Trial 1:

* Residence outside the study area or planning to move out in the following 18 months from enrollment
* Gestational age at the first antenatal visit \> 28 weeks of pregnancy
* Known history of allergy to sulfa drugs or mefloquine
* Known history of severe renal, hepatic, psychiatric or neurological disease
* MQ or halofantrine treatment in the preceding 4 weeks
* HIV infection
* Participating in other studies

Trial 2:

* Residence outside the study area or planning to move out in the following 10 months from enrollment
* Gestational age at the first antenatal visit \> 28 weeks of pregnancy
* Known history of allergy to CTX or MQ
* Known history of severe renal, hepatic, psychiatric or neurological disease
* MQ or halofantrine treatment in the preceding 4 weeks
B: Inclusion Criteria:

* Gestation of at least 16 weeks and \<37 weeks;
* P. falciparum monoinfection of any density, with or without symptoms
* Hb equal or higher than 7 g/dL;
* At least 15 years old;
* Residence within the health facility catchment's area;
* Willing to deliver at the health facility;
* Willing to adhere to study requirements (including in Zambia and Malawi, HIV VCT)
* Ability to provide written informed consent; if the woman is minor of age/not emancipated, the consent must be given by a parent or legal guardian according to national law (however, in this case, the investigator is responsible to check that the woman herself is also freely willing to take part in the study, and the woman will be asked to sign for "assent").

Exclusion Criteria:

* History of allergic reactions to the study drugs;
* History of known pregnancy complications or bad obstetric history such as repeated stillbirths or eclampsia;
* History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis;
* Current cotrimoxazole prophylaxis or ARV treatment;
* Any significant illness at the time of screening that requires hospitalization, including severe malaria;
* Intent to move out of the study catchment area before delivery or deliver at relative's home out of the catchment area.
* Prior enrollment in the study or concurrent enrollment in another study.
* Unable to take oral medication
* Clear evidence of recent (1 week) treatment with antimalarials or antimicrobials with antimalarial activity (clindamycin; azythromycin; etc.)
C: Inclusion Criteria:

* Pregnancy between 16 and 28 weeks of gestation
* Residence near the maternity clinics
* Intention to continue the ante-natal care and deliver at the study maternity clinic
* Ability to take drugs by oral route
* Written informed consent (parents or guardian if aged \< 18 years)

Exclusion Criteria:

* Pregnancy prior to 16 weeks or after 28 weeks of gestation
* Previous suspected reaction to sulfadoxine-pyrimethamine or mefloquine
* History of neurological or psychiatric event
* Intake of sulfadoxine-pyrimethamine or mefloquine within 4 weeks of enrollment
* Current treatment with halofantrine
D: Inclusion Criteria:

* Less than 28 weeks of pregnancy

Exclusion Criteria:

* Previous allergic reactions to sulphonamides

Answer: B