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    Summary
    EudraCT Number:2014-004952-80
    Sponsor's Protocol Code Number:A0661158
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-03
    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 number2014-004952-80
    A.3Full title of the trial
    Phase 3, Open-Label, Randomized, Comparative Study to Evaluate Azithromycin plus Chloroquine and Sulfadoxine plus Pyrimethamine Combinations for Intermittent Preventive Treatment of Falciparum Malaria Infection in Pregnant Women in Africa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
    A.4.1Sponsor's protocol code numberA0661158
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01103063
    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 code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number018007181021
    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.3.2Product code PF-06425116
    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 INN azithromycin
    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 codePF-06425116
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Fansidar
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical 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 INNSULFADOXINE
    D.3.9.1CAS number 2447-57-6
    D.3.9.4EV Substance CodeSUB10700MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPYRIMETHAMINE BITARTRATE
    D.3.9.3Other descriptive nameFansidar
    D.3.9.4EV Substance CodeSUB04144MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Intermittent Preventive Treatment In Pregnancy (IPTp)
    E.1.1.1Medical condition in easily understood language
    Intermittent preventive treatment of falciparum malaria in pregnant women (IPTp)
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10025487
    E.1.2Term Malaria
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To establish superiority of Azithromycin/chloroquine (AZCQ) over Sulfadoxine-pyrimethamine (SP) in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.
    E.2.2Secondary objectives of the trial
    Proportion of subjects with Low birth weight (LBW) (less than [<] 2500 gram [g]) live neonates.
    Proportion of subjects with severe anemia (hemoglobin <8 gram per decilitre [g/dL]).
    Proportion of subjects with anemia (hemoglobin <11 g/dL).
    Proportion of subjects with placental parasitemia.
    Occurrence of Sexually transmitted infections (STIs).
    Safety and tolerability of the 2 treatment regimens.
    Presence of subjects with a sub-optimal pregnancy outcome including neonatal deaths and congenital malformations, defined as any of the following: live-borne neonate (singleton) with low birth-weight (or LBW for short, defined as live birth weight <2,500 g), premature birth (<37 weeks), abortion (less than or equal to [<=] 28 weeks), still birth (greater than [>] 28 weeks), neonatal death, congenital malformation, lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pregnant women (all gravidae) with greater than or equal to (>=) 14 and less than or equal to (<=) 26 weeks of gestational age (by ultrasound).
    2. Evidence of a personally signed and dated informed consent/assent document. Assent will be obtained from subjects <18 years of age.
    3. Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    4. Subjects agreeing to be supervised for treatment administration, and available for all follow up visits as per protocol, including follow ups at delivery and on 28 days post-delivery.

    E.4Principal exclusion criteria
    1. Age <16 years old or >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 g/dL (measured at baseline).
    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, chloroquine, and sulfadoxine-pyrimethamine) or to any macrolides or sulphonamides.
    10. Present history of smoking or alcohol or drug abuse since first becoming aware of current pregnancy.
    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. Requirement to use medication during the study that might interfere with the evaluation of the study drug (eg, trimethoprim-sulfamethoxazole use in subjects positive for Human immunodeficiency virus [HIV] infection) or contra-indicated during pregnancy per package inserts.
    15. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
    16. Evidence of current obstetric complications that may adversely impact the pregnancy and/or fetal outcomes, including presence of congenital anomalies, placenta previa or abruption.
    17. Known severe sickle cell (SS) disease or sickle-hemoglobin C (SC) anemia.
    18. 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 Subjects With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 40 weeks of gestational age
    E.5.2Secondary end point(s)
    1) At 40 Weeks Gestational Age
    -Percentage of Subjects With Sub-optimal Pregnancy Outcome in Efficacy Analysable Per Protocol (PP) Population
    -Percentage of Neonates With LBW (<2500 g) in ITT Population
    -Percentage of Neonates With LBW (<2500 g) in Efficacy Analysable PP Population
    -Percentage of Subjects With Placental Parasitemia at Delivery
    -Percentage of Subjects With Placental Malaria at Delivery Based on Histology
    -Sexually Transmitted Infection (STI) Episodes Per Subject
    -Percentage of Subjects With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation
    -Percentage of Neonates With Congenital Abnormalities at Birth
    -Birth Weight of Live Borne Neonate
    -Number of Episodes of Symptomatic Malaria Per Subject From First Intermittent Preventive Treatment of Falciparum Dose to Delivery
    -Percentage of Subjects Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery
    -Percentage of Subjects With Peripheral Parasitemia at Delivery
    -Percentage of Subjects With Cord Blood Parasitemia at Delivery
    -Percentage of Neonates With Ophthalmia Neonatorum at Birth Period
    -Percentage of Subjects With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery
    2)Visits 6 and 7
    -Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae
    -Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae
    3) Week 20 to week 40
    - Percentage of Subjects With Pre-eclampsia From Week 20 to Delivery
    4)At 36-38 weeks of gestation
    -Percentage of Subjects With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation
    -Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration
    -Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation
    -Percentage of Subjects With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation
    -Percentage of Subjects With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation
    -Percentage of Subjects With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation
    -Percentage of Subjects With Treponema Pallidum Infection at 36-38 Weeks of Gestation
    -Percentage of Subjects With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation
    -Percentage of Subjects With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation
    5) Day 28 after delivery
    -Percentage of Perinatal or Neonatal Deaths
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Approximately 40 weeks of gestational age
    2)Visits 6 and 7
    3) From Week 20 to approximately 40 weeks of gestational age
    4) At and up to 36-38 weeks of gestation
    5) Day 28 after delivery
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days3
    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: 2891
    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: 182
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2709
    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 No
    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 2891
    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: Uganda
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