Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa

• Status: Terminated
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Collaborators: London School of Hygiene and Tropical Medicine; Medicines for Malaria Venture
• Treatments: Azithromycin; Chloroquine; Chloroquine diphosphate; Fanasil, pyrimethamine drug combination; Pyrimethamine; Sulfadoxine

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.