An Open Label, Non-Comparative Study To Evaluate Parasitological Clearance Rates and Pharmacokinetics of Azithromycin and Chloroquine Following Administration of a Fixed Dose Combination of Azithromycin and Chloroquine (AZCQ) in Asymptomatic Pregnant Women With Plasmodium Falciparum Parasitemia in Sub-Saharan Africa

Pfizer Inc0 sites168 target enrollmentApril 7, 2015

Overview

No summary available.

Registry

who.int

Start Date

April 7, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•1\. Primigravidae and secundigravidae pregnant women at greater than or equal to (\>\=) 14 and less than or equal to (\<\=) 30 weeks of gestational age (confirmed by ultrasound examination).
•2\. Evidence of asymptomatic parasitemia with Plasmodium falciparum monoinfection (confirmed by microscopy) with parasite counts in the range of 80\-100,000 per microliter on thick blood smears.
•3\. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative if a subject is less than \[\<] 18 years of age) 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 \<18 years of age.
•4\. Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
•5\. Subjects supervised for treatment administration, and available for all follow up visits as per protocol.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 168
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 127
•F.1\.3 Elderly (\>\=65 years) no

•1\. Age \<16 years old or greater than (\>)35 years old.
•2\. Multiple gestations (more than one fetus) as per the ultrasound results at screening.
•3\. Clinical symptoms of malaria.
•4\. Hemoglobin \<8 gram per deciliter (g/dL).
•5\. Any condition requiring hospitalization or evidence of severe concomitant infection at time of presentation.
•6\. Use of antimalarial drugs in previous 4 weeks.
•7\. History of convulsions, hypertension, diabetes or any other chronic illness that may
•adversely affect fetal growth and viability.
•8\. Inability to tolerate oral treatment in tablet form.
•9\. Known allergy to the study drugs (Azithromycin \[AZ], Chloroquine \[CQ], and Sulfadoxine\-pyrimethamine \[SP]) or to any macrolides or sulphonamides.