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

Condition(s) targeted: Asymptomatic Parasitemia In Pregnancy

Intervention: Azithromycin plus chloroquine (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Official 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication

Secondary outcome:

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

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

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

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

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

Detailed description: After interim analysis of efficacy data by an External Data Monitoring Committee, this study was terminated. Investigators were notified on 22 Aug 2013. There were no safety concerns that led to this termination.

Minimum age: 16 Years. Maximum age: 35 Years. Gender(s): Female.

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.

Centre de Sante d'AHOUANSORI -AGUE, Cotonou, Benin

Hôpital Bethesda, Cotonou, Benin

Siaya District Hospital, Siaya, Kenya

Zomba Central Hospital, Zomba, Malawi

National Institute for Medical Research (Mwanza Centre)/ Nyamagana District Hospital, Mwanza 1903, Tanzania

Mulanda Health Centre IV, Kampala, Uganda

Teule Hospital, Muheza, Tanga, Tanzania

To obtain contact information for a study center near you, click here.

Starting date: March 2011
Last updated: January 22, 2015