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

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NCT01103713

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Study Location
Centre de Sante d'AHOUANSORI -AGUE
Cotonou, , , Benin
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Asymptomatic Parasitemia In Pregnancy
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16-35 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Asymptomatic Parasitemia In PregnancyEvaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa NCT01103713
  1. Cotonou,
  2. Cotonou,
  3. Siaya,
  4. Zomba,
  5. Muheza, Tanga
  6. Mwanza,
  7. Kampala,
Female
16 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asymptomatic Parasitemia In Pregnancy
Intervention  ICMJE Drug: 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).
Other Name: Zithromax; Aralen
Study Arms  ICMJE Experimental: AZCQ
Azithromycin/Chloroquine
Intervention: Drug: Azithromycin plus chloroquine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 18, 2014)		168
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2010)		166
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 16 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Benin,   Kenya,   Malawi,   Tanzania,   Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01103713
Other Study ID Numbers  ICMJE A0661201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP