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    Summary
    EudraCT Number:2014-004906-14
    Sponsor's Protocol Code Number:A0661201
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-004906-14
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa
    A.4.1Sponsor's protocol code numberA0661201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01103713
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number18007181021
    B.5.5Fax number13037391119
    B.5.6E-mailClinicalTrials.govCallCenter@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameazithromycin and chloroquine
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAzithromycin
    D.3.9.1CAS number 83905-01-5
    D.3.9.2Current sponsor codePF-06425116
    D.3.9.3Other descriptive nameAZITHROMYCIN
    D.3.9.4EV Substance CodeSUB05660MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCHLOROQUINE
    D.3.9.1CAS number 54-05-7
    D.3.9.2Current sponsor codeSUB06196MIG
    D.3.9.4EV Substance CodeSUB06196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number155
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asymptomatic Parasitemia
    E.1.1.1Medical condition in easily understood language
    Protozoal infection caused by any of the five species of Plasmodia and transmitted by anopheline mosquitoes
    E.1.1.2Therapeutic area Diseases [C] - Parasitic Diseases [C03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the peripheral parasitological clearance rate of Azithromycin/chloroquine (AZCQ) on Day 28 (Polymerase chain-reaction [PCR] corrected) following first dose of 3-day dosing regimen of AZCQ in asymptomatic pregnant women with Plasmodium falciparum parasitemia.
    E.2.2Secondary objectives of the trial
    Parasitological clearance rates (PCR corrected) at Days 7, 14, 21, 35, and 42 post first dose of study medication.
    Parasitological clearance rates (PCR uncorrected) at Days 7, 14, 21, 28, 35, and 42 post first dose of study medication.
    Pharmacokinetic exposure of AZCQ.
    Safety and tolerability of AZCQ
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Primigravidae and secundigravidae pregnant women at greater than or equal to (>=) 14 and less than or equal to (<=) 30 weeks of gestational age (confirmed by ultrasound examination).
    2. Evidence of asymptomatic parasitemia with Plasmodium falciparum monoinfection (confirmed by microscopy) with parasite counts in the range of 80-100,000 per microliter on thick blood smears.
    3. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative if a subject is less than [<] 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.
    4. Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    5. Subjects supervised for treatment administration, and available for all follow up visits as per protocol.

    E.4Principal exclusion criteria
    1. Age <16 years old or greater than (>)35 years old.
    2. Multiple gestations (more than one fetus) as per the ultrasound results at screening.
    3. Clinical symptoms of malaria.
    4. Hemoglobin <8 gram per deciliter (g/dL).
    5. Any condition requiring hospitalization or evidence of severe concomitant infection at time of presentation.
    6. Use of antimalarial drugs in previous 4 weeks.
    7. History of convulsions, hypertension, diabetes or any other chronic illness that may
    adversely affect fetal growth and viability.
    8. Inability to tolerate oral treatment in tablet form.
    9. Known allergy to the study drugs (Azithromycin [AZ], Chloroquine [CQ], and Sulfadoxine-pyrimethamine [SP]) or to any macrolides or sulphonamides.
    10. Present history of smoking or alcohol or drug abuse since becoming pregnant.
    11. Participation in other studies within 30 days before the current study begins and/or during study participation.
    12. Inability to comprehend and/or unwillingness to follow the study protocol.
    13. Concurrent participation in another investigational study.
    14. Previously randomized in this study.
    15. Requirement to use medication during the study that might interfere with the evaluation of the study drug (for example, trimethoprim-sulfamethoxazole use in subjects positive for HIV infection) or is contra-indicated during pregnancy per package inserts.
    16. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that increase the risk associated with study participation or investigational product administration or interfer with the interpretation of study results and, made the subject inappropriate for entry into this study
    17. Evidence of current obstetric complications that adversely impacted the pregnancy and/or fetal outcomes, including presence of congenital anomalies, placenta previa or abruption.
    18. Known severe sickle cell (SS) disease or sickle-hemoglobin C (SC) anemia.
    19. Known family history of prolonged QT syndrome, serious ventricular arrhythmia, or sudden cardiac death.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of Subjects With Parasitological Response (PCR corrected) at Day 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    E.5.2Secondary end point(s)
    Percentage of Subjects With Parasitological Response (PCR corrected) Day 7, 14, 21, 35, and 42
    Percentage of Subjects With Parasitological Response (PCR uncorrected) Days 7, 14, 21, 28, 35, and 42
    Plasmodium falciparum Parasite Count Days 7, 14, 21, 28, 35, and 42
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 7, 14, 21, 35, and 42
    Days 7, 14, 21, 28, 35, and 42
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Benin
    Kenya
    Malawi
    Tanzania, United Republic of
    Uganda
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months17
    E.8.9.2In all countries concerned by the trial days19
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 168
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 41
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 127
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects less than 18 years of age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 168
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Kenya
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