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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01103713
• Date of registration: 07/04/2010
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa
• Scientific title: 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
• Date of first enrolment: March 2011
• Target sample size: 168
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01103713
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Benin, Kenya, Malawi, Tanzania, Uganda

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 16 Years
Age maximum: 35 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Asymptomatic Parasitemia In Pregnancy

Intervention(s)

Drug: Azithromycin plus chloroquine

Primary Outcome(s)

Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication [Time Frame: Day 28]

Percentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication [Time Frame: Day 28]

Secondary Outcome(s)

Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication [Time Frame: Days 7, 14, 21, 28, 35, and 42]

Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication [Time Frame: Days 7, 14, 21, 35, and 42]

Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication [Time Frame: Days 7, 14, 21, 28, 35, and 42]

Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication [Time Frame: Days 7, 14, 21, 28, 35, and 42]

Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication [Time Frame: Days 7, 14, 21, 35, and 42]

Secondary ID(s)

A0661201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/01/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01103713