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

NCT01103713 | Terminated Phase 3 Results DMC

• 1 other identifier: A0661201
• Study Type: interventional
• Target: 168
• Locations: 5 countries
• Sites: 7

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.

Conditions

Asymptomatic Parasitemia In Pregnancy

Keywords

P. falciparum malaria; asymptomatic parasitemia; parasitological clearance; Intermittent Preventive Treatment of Falciparum Malaria in Pregnant Women (IPTp)

Outcome Measures

Primary Outcomes (2)

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

  The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.

  Day 28

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

  The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.

  Day 28

Secondary Outcomes (5)

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

  Days 7, 14, 21, 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

  Days 7, 14, 21, 35, and 42

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

  Days 7, 14, 21, 28, 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

  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

  Days 7, 14, 21, 28, 35, and 42

Other Outcomes (11)

• Summary of Pregnancy Outcome: Location of Delivery

  Following delivery or pregnancy termination

• Summary of Pregnancy Outcome: Mode of Delivery

  Following delivery or pregnancy termination

• Summary of Pregnancy Outcome: Delivery Assisted by Trained Obstetric Personnel?

  Following delivery or pregnancy termination

Study Arms (1)

AZCQ

EXPERIMENTAL

Azithromycin/Chloroquine

Drug: Azithromycin plus chloroquine

Interventions

Azithromycin plus chloroquine 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).

Also known as: Zithromax; Aralen

AZCQ

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

Centre de Sante d'AHOUANSORI -AGUE

Cotonou, Benin

Location

Hôpital Bethesda

Cotonou, Benin

Location

Siaya District Hospital

Siaya, Kenya

Location

Zomba Central Hospital

Zomba, Malawi

Location

Teule Hospital

Muheza, Tanga, Tanzania

Location

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

Mwanza, 1903, Tanzania

Location

Mulanda Health Centre IV

Kampala, Uganda

Location

Related Links

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

MeSH Terms

Interventions

Azithromycin; Chloroquine

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 15, 2010
• Study Start: March 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 26, 2015
• Results First Posted: January 26, 2015

Record last verified: 2015-01

Locations

BE (2); TA (2); KE (1); MA (1); UG (1)