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

Condition(s) targeted: Intermittent Preventive Treatment In Pregnancy (IPTp)

Intervention: Azithromycin plus chloroquine (Drug); sulfadoxine-pyrimethamine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Official title: A Phase 3, Open Label, Randomized, Comparative Study To Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Subjects with sub-optimal pregnancy outcome

Secondary outcome:

Occurrence at birth of a LBW live neonate

Occurrence of severe maternal anemia (Hb <8 g/dL)

Occurrence of anemia (Hb <11 g/dL)

Occurrence of placental parasitemia

Occurrence of placental malaria as determined by histology

Number of episodes of STIs per subject including T. pallidum, N. gonorrhoeae, C. trachomatis, during the study period (diagnosis based on clinical presentation and/or on laboratory test results between Weeks 36-38).

Occurrence at birth of a neonates with congenital abnormalities

Occurrence of a perinatal or neonatal death

Birth weight of the live-borne neonate (singleton);

Number of episodes of symptomatic malaria per subject anytime from first IPTp dose administration to delivery

Occurrence of a subject requiring additional treatment for symptomatic malaria during the study period following the first dose (diagnosed based on clinical presentation and/or lab test results)

Occurrence of peripheral parasitemia

Occurrence of peripheral parasitemia

Occurrence of cord blood parasitemia

Occurrence of STIs including T. pallidum, N. gonorrhoeae, C. trachomatis during the study period following first dose (diagnosed based on clinical presentation prior to Week 36-38 and/or lab test results between Week 36-38 of gestation)

Occurrence of a positive result for C. trachomatis infection (diagnosed based on lab result)

Occurrence of a positive result for N. gonorrhoeae infection (diagnosed based on lab result)

Occurrence of a positive result for T. pallidum test (diagnosed based on lab result)

Occurrence of a T. vaginalis infection (diagnosed based on lab result);

Occurrence of bacterial vaginosis (diagnosed based on lab result);

Occurrence of ophthalmia neonatorum (diagnosed based on lab test results) in the neonate;

Occurrence of bacterial infections including pneumonia and other lower respiratory tract infections anytime from first IPTp dose administration to delivery;

Occurrence of pre-eclampsia from Week 20 to delivery;

Occurrence of nasopharyngeal swabs positive for macrolide resistant and penicillin resistant Streptococcus pneumoniae. This test will be done in about 600 subjects each from the AZCQ and SP arms from two or more sites.

Minimum age: 16 Years. Maximum age: 35 Years. Gender(s): Female.

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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Centre de Recherches Entomologique de Cotonou, Cotonou, Benin; Recruiting

Siaya District Hospital, Siaya, Kenya; Recruiting

Zomba Central Hospital, Zomba, Malawi; Recruiting

National Institute for Medical Research NIMR Mwanza Centre/ Nyamagana District Hospital, Mwanza, Tanzania; Recruiting

Mulago Hospital Complex, Kampala, Uganda; Active, not recruiting

Teule Hospital, Muheza, Tanga, Tanzania; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: October 2010
Last updated: February 5, 2013