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Data Sheet of Clinical Trial C.T DATA SHEET OF CLINICAL TRIAL C.T. No 075-15 CLINICAL TRIAL REGISTRATION (EC) I. SPONSOR INFORMATION Foreign National TYPE OF INSTITUTION II. CLINICAL TRIAL GENERAL INFORMATION 1. CLINICAL TRIAL IDENTIFICATION Scientific Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO COMPARE THE EFFICACY AND SAFETY OF LEFAMULIN (BC 3781) VERSUS MOXIFLOXACIN (WITH OR WITHOUT ADJUNCTIVE LINEZOLID) IN ADULTS WITH COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA Public Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-A CLINICAL DUMMY STUDY TO COMPARE THE EFFICACY AND SAFETY OF LEFAMULIN (BC 3781) VERSUS MOXIFLOXACIN (WITH OR WITHOUT ADJUNCTIVE LINEZOLID) IN ADULTS WITH COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA. Secundary ID(s): WHO UTN: PER-075-15 Protocol Code: NAB-BC-3781-3101 Clinicaltrials.gov: NA EUDRACT N°: NA 1 1-2 2 2-3 Study clinical phase: 3 4 Clinical Trial Total Duration: 24 months No Aplica 0(exploratory trials) Enrolment start date in Peru (Initial) 15/06/2016 Worldwide enrolment start date (dd/ (dd/mm/aaaa): 01/11/2015 mm/aaaa): Enrolment start date in Peru (Posterior) (dd/mm/aaaa): Without starting enrollment In enrollment Peru enrolment status : Enrollment stopped Enrollment closed Other 2. CLINICAL TRIAL GOALS AND DESIGN Randomnized Simple Non randomnized Double Assignation method Type of blinding No aplica Triple Open Single arm Parallel Crossed Factorial Assignation Others: ____________________ Study Design multicenter, multinational, randomized, double-blind, double-dummy, active-controlled efficacy and safety study in subjects with CABP Purpose • Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (FDA endpoint). • Demonstrate the NI of lefamulin versus comparator with respect to the Investigator’s Assessment of Clinical Response at Test of Cure (TOC) (i.e., 5-10 days after the last dose of study drug) in the modified-ITT (mITT) and Clinically Evaluable at TOC (CE-TOC) Analysis Sets (EMA endpoint). 3. STUDY INTERVENTION Indicate if the product is being developed as: Pharmaceutical product Medical device Herbal product Type of research product Galenic product Complementary product Dietary product and sweetener Other: ____________________ Research product identification N° Product name Generic name Product type ATC 1 Lefamulin BC 3781 Producto en investigación de origen J01 - Antibacterianos de uso químico sistémico Página 1 de 4 N° Comparator name Generic name Product type ATC 1 LINEZOLID LINEZOLID Medicamento J01 - Antibacterianos de uso sistémico 2 Moxifloxacin Hetero Moxifloxacino Medicamento J01 - Antibacterianos de uso sistémico Intervention(s) description: N° of Group Name Type of group Intervention(s) description participants Subjects' treatment time 23 days Subjects' follow up time 33 days 4. Study Population Inclusion Criteria: 1. 1. Male/female &#61619; 18 years of age 2. Provide written IC and be willing and able to adhere to the study-specified procedures and restrictions. 3. Have an acute illness with at least 3 of the following symptoms consistent with a lower respiratory tract infection:Dyspnea; New or increased cough; Purulent sputum production; Chest pain due to pneumonia 4. Have at least 2 of the following vital sign abnormalities: Fever; Hypotension; Tachycardia; Tachypnea 5. Have at least 1 other clinical sign or laboratory finding of CABP: Hypoxemia; Auscultatory and/or percussion findings consistent with pneumonia; White blood cell count >10,000 cells/mm3 or <4500 cells/mm3 or >15% immature neutrophils (bands) regardless of total WBC count 6. Have radiographically- documented pneumonia within 24 hours before enrollment 7. Have a Pneumonia Outcomes Research Team Risk Class &#8805;III. 8. If female, meets the following criteria: Surgically sterile or &#8805;2 years postmenopausal, or if of childbearing potential, has a negative pregnancy test, and if participating in sexual activity that may lead to pregnancy, agrees to use an effective dual method of contraception during the study and for &#8805;28 days after the last dose of study drug 9. If male, meets the following criteria: If not surgically sterile and if participating in sexual activity that may lead to pregnancy, agrees to use an effective dual method of contraception Exclusion Criteria: 1. 1. Have received more than a single dose of a short-acting oral or IV antibacterial for CABP within 24 h- before randomization. 2. Require concomitant systemic antibacterial therapy against CABP pathogens 3. Have been hospitalized for 2 or more days within 90 days prior to the onset of symptoms 4. Have CABP caused by a pathogen known to be resistant to any of the study drugs 5. Have a noninfectious cause of pulmonary infiltrates 6. Have confirmed or suspected pleural empyema 7. Require mechanical ventilation. 8. Have cardiac events or dysfunction 9. Be receiving a strong p-glycoprotein or CYP3A inducer or inhibitor 10. Have a history of tendon disease/disorder, myasthenia gravis, or known or suspected central nervous system disorders 11. Have a history of any hypersensitivity or allergic reaction to any fluoroquinolone, or any drug in the pleuromutilin class 12. Have severely impaired renal function, defined as creatinine clearance. 13. Have evidence of significant hepatic, hematologic, or immunologic disease including any of the following: 14. Have known or suspected severe immunosuppression, defined as receipt of corticosteroid therapy within the previous 8 w. 15. Life expectancy of &#8804;3 months because of any disease other than the current episode of CABP 16. Have participated in any study involving administration of an investigational agent or device within 30 days before enrollment. 17. Previously treated with lefamulin or previously enrolled in this study. Studied Condition: N/A Studied Condition J159Bacterial pneumonia, Medical speciality : Infectology classification(CIE-10): unspecified • Sud Africa • Tailandia • Polonia • Argentina • Bulgaria • Rumania Countries where the enrolment is • Peru • Georgia • Rusia conducted: • Estados Unidos • Hungria • Ucrania • Filipinas • Letonia • Serbia Number of participants per gender 32 >Number of subjects to be included (Initial): 738 in all the countries: Number of participants per gender 0 (Posterior): Population to be included by gender Women Men Both Healthy volunteers Yes No Subordinate Groups Yes No Indigenous or native people Yes No Minors Yes No Indicate if the study population Subjects with disabilities to grant consent includes: Yes No Women of childbearing age Yes No Pregnant women Yes No Women during labor, puerperium or lactation Yes No Fetus Yes No Range of age of subjects to be Adults(18-64 years) Yes No included: Elderly (>= 65 years) Yes No Under 18 years Yes No - In Utero Yes No - Preterm newborn infants (up to gestational age < 37 weeks) Yes No - Newborns (0-27 days) Yes No Página 2 de 4 - Infants and toddlers (28 days-23months) Yes No - Children (2 - 11 years) Yes No - Adolescents (12 - 17 years) Yes No 5. EVALUATION CRITERIA Primary Evaluation Criteria N° Evaluation criteria name Method of measurement Time point for the measurement Secondary Evaluation Criteria N° Evaluation criteria name Method of measurement Time point for the measurement 6. DATA MONITORING Existence of the Data Monitoring ¿Interim analysis is planned? Yes No Committee(CMD) Yes No III. INFORMATION FROM THE FINANCING SOURCE 1. INFORMATION FROM THE FINANCING SOURCE Sponsor Name 2. Sponsor Responsibilities Institution Name Responsibility Inform to the OGITT of the NIH when the first subject is enrolled in Peru, and the end date of enrollment in the country. Submit progress reports to the National Health Institute during the execution of the Clinical Trial. Submit to the OGITT of the NIH the final reports as well as the results, conclusions, and publication of the clinical trial. Notify to the OGITT of the NIH the adverse events and deviations as established in the Clinical Trials Regulation. Inform and describe the reasons for a suspension and cancellation of the clinical trial. Provide the facilities for the inspection of the execution of the clinical trial by the staff of the General Office of Research and Technology Transfer (OGITT) of the National Institute of Health. False IV. RESEARCH SITE, PRINCIPAL INVESTIGATOR, ETHICS COMMITTEE Research Site 1 of 1 1. RESEARCH SITE WHERE THE CLINICAL TRIAL WILL BE CONDUCTED CLINICA PERUANO AMERICANA S. RCI N°: 00442 Research site: A. - Centro de Investigación Clínica Trujillo E.I.R.L 2. PRINCIPAL INVESTIGATOR Full name: LUIS ALBERTO, CAMACHO COSAVALENTE 3. CO-INVESTIGATOR Coinvestigator 1: Jessy del Pilar, Sanchez Pesantes Coinvestigator 2: EDWARD VALDEMAR, CHAVEZ CRUZADO Coinvestigator 3: German Jesus, Gastelo Villanueva 4. INSTITUTIONAL RESEARCH ETHICS COMMITTEE (CIEI) THAT APPROVED THE TRIAL FOR THE SITE POLICLINICO ASOCIACION BENEFICA PRISMA - Comité RCIEI N°: 00006 Ethics Committe Name: Institucional de Etica en Investigación de la Asociación Benéfica Prisma Approval date: 29/10/2015 End approval date: 28/10/2016 CONTACT DATA (Legal Representative of CIEI) Full Name: Salomon Wilfredo , Zavala Sarrio E-mail: [email protected] Calle Carlos Gonzales 251 Urb. Telephone number: 616-5500 Address: Maranga. (Lima - Lima - San Miguel) VI. SHARED USE OF CLINICAL TRIAL DATA (ANONIMIZED INDIVIDUAL DATA) ¿Is there a plan for sharing of Yes No Not decided deidentified individual clinical trial participant-level data (IPD) to
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