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Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa

Last updated on March 14, 2019

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Study Location
Centre de Sante d'AHOUANSORI -AGUE
Cotonou, , Benin
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Asymptomatic Parasitemia In Pregnancy
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.
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- Primigravidae and secundigravidae pregnant women at >=14 and age (confirmed by ultrasound examination).

- Evidence of asymptomatic parasitemia with Plasmodium falciparum monoinfection
(confirmed by microscopy) with parasite counts in the range of 80 100,000/uL on thick
blood smears.

- Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative if a subject is has been informed of all pertinent aspects of the study and that all questions by the
subject have been sufficiently answered. Assent will be obtained from subjects years of age.

- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Age 35 years old.

- Multiple gestations (more than one fetus) as per the ultrasound results at screening.

- Clinical symptoms of malaria.

- Hemoglobin

- Any condition requiring hospitalization or evidence of severe concomitant infection at
time of presentation.

- Use of antimalarial drugs in previous 4 weeks.

- History of convulsions, hypertension, diabetes or any other chronic illness that may
adversely affect fetal growth and viability.

- Known allergy to the study drugs (AZ, CQ, and SP) or to any macrolides or
sulphonamides.

- Requirement to use medication during the study that might interfere with the
evaluation of the study drug of AZ or CQ or is contra indicated during pregnancy per
package inserts.

- Severe acute or chronic medical or psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation or investigational
product administration or may interfere with the interpretation of study results and,
in the judgment of the investigator, would make the subject inappropriate for entry
into this study.

- 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.

NCT01103713
Pfizer
Terminated
Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa

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