Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised Double Blind Clinical Trial of Amodiaquine (AQ) and Sulphadoxine-pyrimethamine (SP) Used Singly and in Combination (AQ+SP) Compared With Chloroquine (CQ) in the Treatment of Falciparum Malaria Infection in Pregnancy
Brief Summary: Malaria in pregnancy is potentially fatal to both the mother and the foetus particularly in the primigravidae. Implementation of appropriate control and preventive measures is challenged by the fact that malaria infection in pregnancy is often asymptomatic and parasitized red blood cells sequestrated in the placental microcirculation may not be detectable in the peripheral blood. In addition, the widespread prevalence of parasites resistant to chloroquine and sulphadoxine-pyrimethamine (SP) and, the safety concerns about newer antimalarials, poverty and inadequate supply have made antimalarial treatment options available to pregnant women very limited. These have necessitated an urgent search for alternative safe and efficacious treatment options for pregnant women. The objective of this study is to assess the efficacy, safety and tolerability of four antimalarial treatment options in rural Ghana within a programme setting.


Options:
A: Inclusion Criteria:

* HIV-positive pregnant women between 16-28 weeks of gestation identified through VCT
* HIV-negative pregnant women between 16-28 weeks of gestation identified through VCT
* Residence within the catchment area of the health facility
* Willing to deliver at the health facility
* Willing to agree to adhere to the requirements of study participation (including monthly ANC visits and willing to allow all study procedures)
* Willing to provide written informed consent
* Aged 18 years and above

Exclusion Criteria:

* Severe anemia (Hb \< 6 g/dL)
* History of allergic reactions to sulfa drugs
* History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section)
* History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis, prior to randomization
* Any significant presenting illness that requires hospitalization
* 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
B: Inclusion Criteria:

* First or second pregnancy
* Greater than 16 weeks gestation
* Less than 28 weeks gestation
* Consent for HIV testing

Exclusion Criteria:

* Less than 15 years old
C: Inclusion Criteria:

* Man and non-pregnant women aged between 15 and 50.
* P.falciparum mono-infection of at least 1,000 parasites/µl.
* Body temperature ≥ 37.5°C at the moment of enrolment or history of fever in the preceding 48 hrs.
* Consent from patient obtained.

Exclusion Criteria:

* Pregnancy.
* Severe P. falciparum malaria .
* Documented intake of SP or Coartem two weeks or less prior recruitment.
* Other cause(s) of fever.
* Evidence of underlying chronic diseases (cardiac, renal, hepatic, malnutrition).
* History of allergy to study drug, or known allergy to other Sulphur drugs such as co-trimoxazol.
D: Inclusion Criteria:

* Gestational age of at least 16 weeks.
* P. falciparum parasitaemia of any density with or without symptoms.
* Informed consent.
* No known adverse reaction to any of the study drugs.
* Residence in the study area.

Exclusion Criteria:

* Past obstetric and medical history that might adversely affect the interpretation of outcomes such as repeated stillbirths and eclampsia.
* History of severe adverse drug reactions to co-trimoxazole in the past.
* Haemoglobin concentration below 5.0 g/dl.
* Severe malaria.

Answer: D