Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa
NCT01103713
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- 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.
- 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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Descriptive Information | ||||
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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 | 168 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |