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

Pfizer

Status and phase

Terminated

Phase 3

Conditions

Intermittent Preventive Treatment In Pregnancy (IPTp)

Treatments

Drug: sulfadoxine-pyrimethamine

Drug: Azithromycin plus chloroquine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01103063

A0661158

Details and patient eligibility

About

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.

Full description

After interim analysis of efficacy data by an External Data Monitoring Committee, this study was terminated. Investigators were notified on 22 Aug 2013. There were no safety concerns that led to this termination.

Enrollment

2,891 patients

Sex

Female

Ages

16 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.