- Pregnant women (all gravidae) with ≥14 and ≤26 weeks of gestational age (by
- Evidence of a personally signed and dated informed consent/assent document. Assent
will be obtained from subjects
- Subjects who are willing to and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
- Subjects who are available for follow up at delivery and on 28 days post delivery.
- Age 35 years old.
- Multiple gestations as per the ultrasound at screening.
- Clinical symptoms of malaria.
- Any condition requiring hospitalization at enrollment.
- History of convulsions, hypertension, diabetes or any other chronic illness that may
adversely affect fetal growth and viability.
- Inability to tolerate oral treatment in tablet form.
- Known allergy to the study drugs (azithromycin, chloroquine, and
sulfadoxine-pyrimethamine) or to any macrolides or sulphonamides.
- Requirement to use medication during the study that might interfere with the
evaluation of the study drug eg, trimethoprim-sulfamethoxazole use in subjects
positive for HIV infection.
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation.
- Evidence of current obstetric complications that may adversely impact the pregnancy
and/or fetal outcomes, including presence of congenital anomalies, placenta previa or
- Known severe Sickle Cell (SS) disease or Sickle Hemoglobin C (SC) anemia.
- Known family history of prolonged QT Syndrome, serious ventricular arrhythmia, or
sudden cardiac death.