You are here

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

Last updated on March 15, 2019

FOR MORE INFORMATION
Study Location
Centre de Santé d'AHOUANSORI-AGUE
Cotonou, , Benin
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Intermittent Preventive Treatment In Pregnancy (IPTp)
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16-35 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Age 35 years old.

- Multiple gestations as per the ultrasound at screening.

- Clinical symptoms of malaria.

- Hemoglobin

- 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.

NCT01103063
Pfizer
Terminated
Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now