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    Summary
    EudraCT Number:2015-002346-32
    Sponsor's Protocol Code Number:SB-2-004-005
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-28
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBulgarian Drug Agency
    A.2EudraCT number2015-002346-32
    A.3Full title of the trial
    A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of Clostridium difficile Associated Diarrhea in Patients with a Diagnosis of a Lower Respiratory Tract Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the potential of SYN-004 in the prevention of Clostridium difficile Associated Diarrhea in patients who are hospitalized for a lower respiratory tract infection and are at risk for Clostridium difficile Associated Diarrhea and who are receiving IV ceftriaxone alone or in
    combination with a macrolide.
    A.4.1Sponsor's protocol code numberSB-2-004-005
    A.5.4Other Identifiers
    Name:IND numberNumber:73440
    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 SponsorSynthetic Biologics, 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 supportSynthetic Biologics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSynthetic Biologics, Inc.
    B.5.2Functional name of contact pointTracey Roberts
    B.5.3 Address:
    B.5.3.1Street Address9605 Medical Center Drive, Ste. 270
    B.5.3.2Town/ cityRockville
    B.5.3.3Post codeMD 20850
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018606081881
    B.5.6E-mailtroberts@syntheticbiologics.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 nameSYN-004 75mg
    D.3.2Product code SYN-004
    D.3.4Pharmaceutical form Capsule
    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 INNKymerase
    D.3.9.1CAS number 1792207-66-9
    D.3.9.2Current sponsor codeSYN-004
    D.3.9.3Other descriptive namebeta-Lactamase (synthetic Bacillus licheniformis isoenzyme)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of Clostridium difficile infection (CDI), Clostridium difficile associated diarrhea (CDAD), antibiotic-associated diarrhea (AAD) and secondary infections with healthcare-acquired drug-resistant pathogens in patients receiving IV β-lactam antibiotic therapy.
    E.1.1.1Medical condition in easily understood language
    Prevention of Clostridium difficile infection, Clostridium difficile associated diarrhea, antibiotic-associated diarrhea and secondary infections with healthcare-acquired drug-resistant pathogens
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10006834
    E.1.2Term C.difficile diarrhea
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effectiveness of treatment with SYN-004 for the prevention of Clostridium difficile (C. difficile) associated diarrhea (CDAD) in patients hospitalized for a lower respiratory tract infection receiving intravenous (IV) ceftriaxone alone or in combination with a macrolide.
    To evaluate the safety and tolerability of SYN-004 in patients with a lower respiratory tract infection receiving IV ceftriaxone alone or in combination with a macrolide.
    E.2.2Secondary objectives of the trial
    To assess the effectiveness of treatment with SYN-004 for the prevention of antibiotic
    associated diarrhea (AAD) in patients hospitalized for a lower respiratory tract infection receiving IV ceftriaxone alone or in combination with a macrolide.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients age ≥50 years
    2. Informed consent (IC) obtained and signed prior to study participation
    3. Expected minimum hospital stay of 5 days
    4. Expected ≥5 day course of intravenous (IV) ceftriaxone alone or in combination with a
    macrolide, e.g., clarithromycin or azithromycin
    5. Clinical diagnosis of moderate to severe lower respiratory tract infection consisting of signs and symptoms of a lower respiratory tract infection and Pneumonia Severity Index
    (PSI/PORT) score for CAP of 90-130, inclusive. Evidence of a new or progressive infiltrate on chest x-ray is recommended. Note: the PSI/PORT score inclusion requirement applies to all patients.
    6. Patients must agree to use an acceptable method of contraception from the time of signing the ICF to 24 hours after the final dose of study drug if the patient is a sexually active female of child bearing potential (defined as all females after puberty who are not postmenopausal for at least 1 year, or surgically sterile). Adequate contraceptive measures include: oral contraceptives (stable use for 2 or more cycles before Screening); intrauterine device; Depo Provera; Norplant System implants; bilateral tubal ligation; partner with a vasectomy; use of a condom or diaphragm plus either contraceptive sponge, foam, or jelly; and abstinence.
    7. Patients must have a negative urine pregnancy test at Day 1 before dosing if a female patient of child bearing potential.
    8. The patient is willing and able to comply with all testing and study requirements as defined in the protocol.
    E.4Principal exclusion criteria
    1. Presence of a diarrheal illness within 72 hours prior to randomization
    2. Current treatment for CDAD or ongoing active CDAD infection, as evidenced by clinical signs of diarrhea along with the presence of toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool
    3. Number of previous CDAD episodes >1 within 12 weeks prior to randomization or CDAD within 4 weeks prior randomization
    4. Use of antibiotics within 1 month of start of study drug except for the current illness. Note: Oral antibiotics for the current episode of lower respiratory tract infection within 72 h prior to the first dose of study drug are allowed
    5. In the judgment of the investigator any factors (e.g., other treatment) that could invalidate the treatment result
    6. Known intolerance of study drug/ingredients
    7. Present or past diagnosis of inflammatory bowel disease such as Crohn's Disease or ulcerative colitis. Evidence of active GI infections e.g., parasitic infection, Salmonella, Shigella
    8. Patients requiring tracheal intubatation and mechanical ventilation. Non-invasive ventilation including biphasic intermittent positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) are acceptable
    9. Patients with bronchiectasis, cystic fibrosis, aspiration pneumonia, confirmed influenza, or chronic alcoholism
    10. Neutrophil count <500 cells/mm3
    11. AST, ALT > 5x upper limit normal (ULN)
    12. Active chemotherapy, receipt of organ transplant
    13. Renal failure requiring dialysis
    14. Patient is currently enrolled in another clinical study or has received an investigational drug or device within 30 days or within a time period consistent with a washout period of 5 half-lives before signing the ICF, whichever is longer
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients with CDAD based on the protocol definition of CDAD from Day 1 to the 4-week Follow-Up Visit in the SYN-004 treatment group compared to the placebo group
    E.5.1.1Timepoint(s) of evaluation of this end point
    4-week Follow-Up Visit
    E.5.2Secondary end point(s)
    - Percentage of patients with CDAD based on the protocol definition of CDAD from Day 1 to the 2-week Follow-Up Visit and 6-week Follow-Up Visit in the SYN-004 treatment group compared to the placebo group
    - Percentage of patients treated for CDAD from Day 1 to the 4-week Follow-Up Visit and from Day 1 to the 6-week Follow-Up Visit in the SYN-004 treatment group compared to the placebo group
    - Percentage of patients with AAD based on the protocol definition of AAD from Day 1 to the 2-, 4- and 6-week Follow-Up Visit in the SYN-004 treatment group compared to the placebo group
    -Percentage of patients treated for AAD from Day 1 to the 4-week Follow-Up Visit and from Day 1 to the 6-week Follow-Up Visit in the SYN-004 treatment group compared to the placebo group.
    - Percentage of patients with diarrhea based on the protocol definition of diarrhea (3 or more unformed/liquid stools per 24 hour period) from Day 1 to the 2-, 4-, and 6-week Follow-up Visits in the SYN-004 treatment group compared to the placebo group.
    - Percentage of patients with CDAD or AAD based on the protocol definition of CDAD or AAD from Day 1 to the Day 1 to the 2-, 4- and 6-week Follow-Up Visit in the SYN-004 treatment group compared to the placebo group
    - Percentage of patients with CDAD or AAD or new colonization with both C. difficile and VRE without diarrhea from Day 1 to the 2-, 4- and 6 week-Follow-Up Visit in the SYN-004 treatment group compared to the placebo group. New colonization is defined as a patient who has a negative screening colonization sample for C. difficile and VRE, and a subsequent positive sample result for both species in the same sample at Treatment Period 2 – 72 Hour Visit or 4-week Follow-Up Visit or Early Termination.
    - Percentage of patients with new colonization with both C .difficile and VRE without diarrhea from Day 1 to the 2-, 4- and 6-week Follow-Up Visit in the SYN-004 treatment group compared to the placebo group
    E.5.2.1Timepoint(s) of evaluation of this end point
    6-week Follow-up Visit
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Canada
    Hungary
    Poland
    Romania
    Serbia
    United States
    E.8.7Trial has a data monitoring committee No
    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.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 297
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state68
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 272
    F.4.2.2In the whole clinical trial 372
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-10
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