Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa
Condition: Asymptomatic Parasitemia In Pregnancy
MeSH terms: Parasitemia
Intervention: Azithromycin plus chloroquine
Intervention description: Study drug is a fixed dose tablet of AZCQ containing 250 mg AZ and 155 mg CQ base. All subjects will be administered a 3 day course of AZCQ IPTp regimen: a single dose of 1000 mg AZ/620 mg CQ base (4 fixed dose combination tablets of AZCQ: 250mg/155mg) administered per os (PO, orally) once daily for 3 days (Days 0, 1, 2).
Intervention MeSH terms: Azithromycin; Chloroquine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 168.0
Sex: Female
Minimum age: 16 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: P. falciparum malaria; asymptomatic parasitemia; parasitological clearance; Intermittent Preventive Treatment of Falciparum Malaria in Pregnant Women (IPTp)

Summary:

      The study will be conducted in asymptomatic pregnant women with P. falciparum parasitemia.
      The subjects will be given 3 day dosing regiment of the fixed-dose combination of
      Azithromycin and Chloroquine. Parasitological clearance rate with polymerase chain reaction
      data will be evaluated on Day 28 as primary endpoint.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primigravidae and secundigravidae pregnant women at >=14 and <=30 weeks of gestational
             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 <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.

          -  Subjects who are willing and able to comply with scheduled visits, treatment plan,
             laboratory tests, and other study procedures.

        Exclusion Criteria:

          -  Age <16 years old or >35 years old.

          -  Multiple gestations (more than one fetus) as per the ultrasound results at screening.

          -  Clinical symptoms of malaria.

          -  Hemoglobin <8 g/dL (measured at baseline).

          -  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.