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

NCT ID: NCT01103713

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-10-31

Brief 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.

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.

Conditions

Asymptomatic Parasitemia In Pregnancy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AZCQ

Azithromycin/Chloroquine

Group Type: EXPERIMENTAL

Azithromycin plus chloroquine

Intervention Type: DRUG

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).

Interventions

Azithromycin plus chloroquine

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 Type: DRUG

Other Intervention Names

Zithromax; Aralen

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Centre de Sante d'AHOUANSORI -AGUE

Cotonou, , Benin

Hôpital Bethesda

Cotonou, , Benin

Siaya District Hospital

Siaya, , Kenya

Zomba Central Hospital

Zomba, , Malawi

Teule Hospital

Muheza, Tanga, Tanzania

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

Mwanza, , Tanzania

Mulanda Health Centre IV

Kampala, , Uganda

Countries

Benin; Kenya; Malawi; Tanzania; Uganda

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661201&StudyName=Evaluate%20Parasitological%20Clearance%20Rates%20And%20Pharmacokinetics%20Of%20The%20Combination%20Of%20Azithromycin%20And%20Chloroquine%20In%20Asymptomatic%20Pregnant%20Wome

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

Other Identifiers

A0661201

Identifier Type: -

Identifier Source: org_study_id