Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
Condition: Intermittent Preventive Treatment In Pregnancy (IPTp)
MeSH terms: Malaria; Malaria, Falciparum
Intervention: Azithromycin plus chloroquine; sulfadoxine-pyrimethamine
Intervention description: combination tablet of 250mg azithromycin/155 chloroquine, Once daily PO for three days per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.; Fansidar tablet (500 mg sulfadoxine /25 mg pyrimethamine), once daily, PO, single dose per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.
Intervention MeSH terms: Azithromycin; Chloroquine; Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2891.0
Sex: Female
Minimum age: 16 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: P. falciparum malaria; IPTp

Summary:

      The primary objective is to establish superiority of AZCQ over SP in protective efficacy for
      IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women (all gravidae) with ≥14 and ≤26 weeks of gestational age (by
             ultrasound).

          -  Evidence of a personally signed and dated informed consent/assent document. Assent
             will be obtained from subjects <18 years of age.

          -  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.

        Exclusion Criteria:

          -  Age <16 years old or >35 years old.

          -  Multiple gestations as per the ultrasound at screening.

          -  Clinical symptoms of malaria.

          -  Hemoglobin < 8 g/dL (at enrollment).

          -  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
             abruption.

          -  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.