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1 Clinical Trial Details (PDF Generation Date :- Fri, 01 Feb :46:32 GMT) CTRI Number Last Modified On 02/06/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2014/05/ [Registered on: 26/05/2014] - Trial Registered Prospectively No Interventional Drug Randized, Parallel Group, Multiple Arm Trial A clinical trial to study the safety, efficacy and tolerability of the drug Ceftazidime-Avibactam(CAZ-AVI) versus Meropenem in patients with Nosocial Pneumonia(NP) including Ventilator Associated Pneumonia(VAP). Phase III, Randized, Multicentre, Double-blind, Double-dummy,Parallel-group Cparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam (CAZ-AVI) Versus Meropenem in the Treatment of Nosocial Pneumonia (NP) Including Ventilator-Associated Pneumonia (VAP) in Hospitalised Adults Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) D4281C00001 Designation Affiliation ClinicalTrials.gov Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Dr Bhavesh Kotak Vice President- Medical and Regulatory Affairs AstraZeneca Pharma India Ltd. Phone Fax Designation Affiliation AstraZeneca Pharma India Ltd., Block N1, 12th Floor, Manyata Embassy Business Park, Rachenahalli, Outer Ring Road, India Bhavesh.Kotak@astrazeneca.c Details Contact Person (Public Query) Ms Ranju Sharma Senior Clinical Research Manager and Country Head AstraZeneca Pharma India Ltd. Block N1, 12th Floor, Manyata Embassy Business Park, Rachenahalli, Outer Ring Road, page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study India Phone Fax > AstraZeneca AB, Södertälje, Sweden. Type of Sponsor AstraZeneca Pharma India Ltd List of Countries Argentina Brazil Bulgaria Chile China Czech Republic France Hungary India Italy Japan Mexico Peru Poland Republic of Korea Russian Federation South Africa Spain Turkey Ukraine United Kingd Viet Nam of Principal Investigator Dr Suresh Ramasubban Dr V Ramasubramanian Source of Monetary or Material Support Primary Sponsor Details AstraZeneca AB Södertälje, Sweden. Pharmaceutical industry-global "Avishkar", P.B. No 2483, Off Bellary Road, Hebbal, Karnataka, India of Site Site Phone/Fax/ Apollo Gleneagles Hospital No. 58, Canal Circular Road Kolkata , West Bengal Kolkata WEST BENGAL Apollo Hospitals (Main), 21, Greams Lane, Off Greams Road, Chennai , Tamilnadu Chennai TAMIL NADU drsuresh@hotmail.c idisdoc@gmail.c Dr K R Raveendra Medical Ro No 72/A, 2nd page 2 / 6

3 Details of Ethics Dr Prachee Sathe Dr Omender Singh College and Research Institute Dept. of Critical Care Medicine Director of Critical Care Max Super Speciality Hospital Floor, New C Block, Victoria Hospital, Fort, , Karnataka Main building, 1st floor ICU, Ruby Hall Clinic, 40 Sassoon road, Pune , Maharashtra Pune MAHARASHTRA 1 Press Enclave Road, Saket New Delhi South DELHI Dr P A Mahesh JSS Hospital Dept of Pulmonology M.G. Road, Mysore , Karnataka Mysore Dr Arun Narayan M S Ramaiah Medical College and Hospitals MSRIT Post, New BEL road, Dr Yatin Mehta Medanta-The Medicity Medanta-The Medicity Sector 38, Gurgaon , Gurgaon HARYANA Dr Narendra Khippal S.M.S Medical College & Hospital Subhash Nagar Shopping Center, Shastri Nagar Jaipur , Jaipur RAJASTHAN drkrraveendra@gmail.c prachee.sathe@gmail.c Omender.critical@gmail.c mahesh1971in@yahoo. c drarunnarayan@gmail.c Yatin.Mehta@Medanta. org drnkhippal@rediffmail.c of Approval Status Date of Approval Is Independent Ethics? Ethical Review Board Approved 23/10/2013 No Ethics Apollo Hospital Ethics of Medical Institution Ethics Approved 10/07/2013 No Approved 27/08/2013 No Approved 26/09/2013 No Institution Ethics Approved 20/06/2014 No JSS Medical College Institutional Ethics Max Healthcare Ethics Medanta Independent Ethics Approved 24/12/2013 No Approved 15/10/2014 No Approved 27/08/2013 No page 3 / 6

4 Regulatory Clearance Status fr DCGI Health Condition / Problems Studied Intervention / Cparator Agent Inclusion Criteria Office of the Ethics Status Approved 02/09/2013 No Date Approved/Obtained 09/04/2014 Health Type Patients Condition Nosocial Pneumonia (NP) Ventilator Associated Pneumonia (VAP) Type Details Intervention Ceftazidime-Avibactam 2000mg ceftazidime plus 500mg avibactam for 7-14 days treatment; Intravenous infusion Cparator Agent Meropenem 1000mg of Meropenem for 7-14 days treatment; Intravenous infusion Age Fr Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 18 to 90 years of age inclusive. Exclusion Criteria Details Females can participate if surgically sterile or cpleted menopause; if able to have children, must have negative serum pregnancy test, agree not to attempt pregnancy and use acceptable contraception while receiving study therapy and for 1 week after last dose of IV study therapy. Onset of sympts more than or equal to 48 hours after admission or less than 7 days after discharge fr an inpatient acute or chronic care facility. New or worsening infiltrate on chest X-ray obtained within 48 hours prior to randization. At least 1 of the following systemic signs: Fever (temperature more than 38 degree C) or hypothermia (rectal/core temperature less than 35 degree C); White blood cell count more than10,000 cells/mm3, or White blood cell count less than 4500 cells/mm3, or more than15% band forms. Exclusion Criteria Pulmonary disease that precludes evaluation of therapeutic response (including, but not limited to, lung cancer, active tuberculosis, cystic fibrosis, granulatous disease, fungal pulmonary infection or recent pulmonary embolism). Patients with lung abscess, pleural empyema or post obstructive pneumonia. Patients with an estimated creatinine clearance 16ml/min by Cockcroft Gault formula or patients expected to require haemodialysis or other renal support while on study therapy. Acute hepatitis in the prior 6 months, cirrhosis, acute hepatic failure or acute decpensation of chronic hepatic failure. Patients receiving hemodialysis or peritoneal dialysis. page 4 / 6

5 Method of Generating Rand Sequence Method of Concealment Blinding/Masking Cputer generated randization Centralized Double Blind Double Dummy Primary Outce Outce Timepoints The proportion of patients with clinical cure in the clinically modified intent-to-treat and clinically evaluable analysis sets (co-primary analyses) Up to 25 days fr randization 21st - 25th day fr randization Secondary Outce Outce Timepoints The proportion of patients with clinical cure in the microbiologically evaluable and extended Microbiologically evaluable analysis sets The proportion of patients with clinical cure in clinically modified intent-to-treat, clinically evaluable, microbiologically modified intent-to-treat, microbiologically evaluable, extended microbiologically evaluable analysis sets The proportion of patients with a favorable per-patient microbiologic response in microbiologically evaluable, extended microbiologically evaluable analysis sets The proportion of favorable per-pathogen microbiologic responses in microbiologically modified intent-to-treat, microbiologically evaluable and extended microbiologically evaluable analysis sets The proportion of favorable per-pathogen microbiologic responses by minimum inhibitory concentration categories in microbiologically modified intent-to-treat, microbiologically evaluable and extended-microbiologically evaluable analysis sets The proportion of patients with clinical cure in patients with pathogens resistant to ceftazidime in clinically evaluable, clinically modified intent-to-treat, microbiologically evaluable analysis sets Proportion of patients with a favorable per-patient microbiologic response in patients with pathogens resistant to ceftazidime in microbiologically evaluable, extended microbiologically evaluable analysis sets The proportion of favorable per-pathogen microbiologic responses in patients with pathogens resistant to ceftazidime in microbiologically evaluable and extended microbiologically evaluable analysis sets The proportion of patients with death due to any cause (all-cause mortality) in the clinically evaluable, clinically modified intent-to-treat and microbiologically modified intent-to-treat analysis Up to 25 days fr randization 21st - 25th day fr randization up to 14 days fr randization up to 14 days fr randization and 21 to 25 fr randization up to 14 days fr randization and 21 to 25 fr randization up to 14 days fr randization and 21 to 25 fr randization up to 14 days fr randization and 21 to 25 fr randization up to 14 days fr randization and 21 to 25 fr randization up to 14 days fr randization and 21 to 25 fr randization at Day 21 to 25 fr randization and Day 28 fr randization page 5 / 6

6 Powered by TCPDF ( Target Sample Size sets Phase of Trial Phase 3 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary The proportion of patients discharged fr hospital in the clinically evaluable, clinically modified intent-to-treat and microbiologically modified intent-to-treat analysis sets Safety and tolerability by incidence and severity of adverse events and serious adverse events, mortality, reasons for discontinuations of study therapy, vital signs, physical exams, electrocardiogram parameters, and clinical laboratory tests Total Sample Size=1600 Sample Size fr India=100 19/06/ /04/2013 Years=3 Months=0 Days=0 Open to Recruitment Open to Recruitment up to 25 days fr randization 21st - 25th day fr randization up to 28 days fr randization Short description of the primary purpose of the protocol, including a brief statement of the study hypothesis. Include publication/s details (link/reference), if any. This is a prospective, randized, multicenter, double-blind, double-dummy parallel-group, cparative study to determine the efficacy, safety, and tolerability of CAZ-AVI versus meropenem in the treatment of adults with NP, including Ventilator Associated Pneumonia. The following hypotheses will be assessed during this study: Intravenous CAZ-AVI will demonstrate clinical efficacy cparable with that of IV meropenem as treatment for patients with NP The safety and tolerability profile of CAZ-AVI administered intravenously is acceptable. This study will randize 1120 eligible Non-VAP patients. Additionally, VAP patients will be recruited such that between 25% and 30% of the total number of patients recruited are VAP in nature. So a minimum total of 1494 patients (1120 Non-VAP plus 374 VAP) and a maximum total of 1600 patients (1120 Non-VAP plus 480 VAP) with NP including VAP will be recruited into this study fr approximately 22 countries. Fr India, a total of 100 patients will be randised fr approximately 12 sites. The recruitment in India is expected to start fr May page 6 / 6