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1 Clinical Trial Details (PDF Generation Date :- Tue, 08 Jan :39:43 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/2012/07/ [Registered on: 16/07/2012] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Multiple Arm Trial A Study Comparing Ceftazidime-Avibactam+Metronidazole Versus Meropenem in Adults With Complicated Intra-abdominal Infections. A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) D4280C00005 dated 5/2/2012 NCT dated 12/22/2011 Designation Affiliation Protocol Number 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) Arun Sundriyal Phone Fax Designation Affiliation Associate Director - Clinical Management PPD Pharmaceutical Development Pvt. Ltd. PPD Pharmaceutical Development Pvt Ltd., Vatika City Point, 11th Floor, Sector 25, Mehrauli Gurgaon Road, Gurgaon Gurgaon HARYANA Arun.Sundriyal@ppdi.com Details Contact Person (Public Query) Arun Sundriyal Associate Director - Clinical Management PPD Pharmaceutical Development Pvt. Ltd. PPD Pharmaceutical Development Pvt Ltd., Vatika City Point, 11th Floor, Sector 25, Mehrauli Gurgaon Road, Gurgaon Gurgaon HARYANA page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > AstraZeneca AB, S Sodertalje, Sweden Type of Sponsor Source of Monetary or Material Support Primary Sponsor Details AstraZeneca AB S Sodertalje, Sweden Pharmaceutical industry-global PPD Pharmaceutical Development Pvt Ltd List of Countries Argentina Belgium Brazil Bulgaria Canada Chile Czech Republic France Germany Greece Israel Italy Romania Russian Federation Spain Thailand Turkey Ukraine United States of America of Principal Investigator Dr Thodana Vadivelu Sekar Dr Sandeep Tiwari 01-Dynasty-B Wing, Andheri-Kurla Road, Andheri (E), Mumbai of Site Site Phone/Fax/ Apollo Speciality Hospitals, Chhatrapati Shahuji Maharaj Medical University Department of Gastroenterology, Lake View Road, K.K.Nagar, Madurai , Madurai TAMIL NADU madurai@aherf-smo.or g Department of Surgery (General), Chhatrapati Shahuji Maharaj sandeep_neelu@yahoo Medical University,.co.in Uttar Pradesh, Lucknow , Lucknow page 2 / 7

3 Details of Ethics Committee Dr Satpal Singh Dr Deepak Govil Dayanand Medical College and Hospital Indraprastha Apollo Hospitals UTTAR PRADESH Department of Gastroenterology, Tagore Nagar, Civil Lines, Ludhiana , Punjab, Ludhiana PUNJAB Department of Surgical Gastroenterology, Sarita Vihar, Delhi Mathura Road, New Delhi , New Delhi DELHI com com DrHariprasad T R K.R.Hospital Department Of Surgery, # 979, 25th Main Road, BSK 1st Stage, 50 Ft. Road, harishermi@hotmail.co m Hanumanthanagar, Bangalore , Bangalore KARNATAKA Dr Randhir Sud Dr Puduccode Parameswaran Sethu Babu Dr Kaushal Yogendrabhai Vyas Medanta - The Medicity, Sai Vani Hospitals Ltd Sheth Vadilal Sarabhai General Hospital, And Sheth Chinai Maternity Hospital Medanta Institute Of Digestive & Hepatobiliary Sciences Medanta,The Medicity, Sector-38, Gurgaon, Haryana Gurgaon HARYANA rsud1@vsnl.com Department of Gastroenterology, Second Floor, sethu9@rediffmail.com /36/6&7, Ramakrishna Math Road, Opp. Indira Park, Domalguda, Hyderabad , Andhra Pradesh,. Hyderabad ANDHRA PRADESH Department of Gastroenterology, Ellis Bridge, Ahmedabad , Ahmadabad GUJARAT kaushalv27@yahoo.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Apollo Speciality Hospitals Ethics Committee Lake View Road, K.K.Nagar, Madurai , Bangalore Central Ethics Committee, No: Approved 15/01/2013 No Approved 18/05/2012 No page 3 / 7

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied 1423,Kullappa Layout, Kullappa Circle, St. Thomas Town Post, Bangalore , Karnataka, Chhatrapati Shahuji Maharaj Medical University Institutional Ethics Committee,Uttar Pradesh, Lucknow , Indraprastha Apollo Hospitals Sarita Vihar, Ethics Committee on Clinical Trials, Delhi Mathura Road, New Delhi , Medanta Independent Ethics Committee,Medanta Institute of Education & Research Regulatory officeiind Floor, OppositeMedical Library Training Block, Medanta- The Medicity, Sector - 38, Gurgaon, Haryana , Sheth V. S. Medical ResearchFoundation Trust, Sheth V. S. General Hospital Ethical Committee, Ellis Bridge, Ahmedabad , Tagore Nagar Institutional Ethics Committee (Drug Trial Ethics Committee),, Civil Lines, Ludhiana , Punjab, Virtuous Independent Ethics Committee, H. No , 2nd floor,adams Heaven, Street No 10, Tarnaka, Secunderabad500017, Andhra Pradesh, for Dr Sethu Babu Status Approved 20/07/2012 No Approved 05/10/2012 No Approved 14/08/2012 Yes Approved 30/07/2012 No Approved 14/04/2012 No Approved 26/06/2012 Yes Date Approved/Obtained 19/04/2012 Health Type Patients Condition Treatment of Complicated Intra-Abdominal Infections Intervention / Type Details page 4 / 7

5 Comparator Agent Intervention Ceftazidime-Avibactam + Metronidazole Inclusion Criteria Ceftazidime 2000 mg and 500 mg of avibactam mg of Metronidazole. Orally. Daily. Arm: 1 Each patient will be on drug therapy for minimum 5 days and maximum 14 days. Comparator Agent Meropenem 1 gram of Meropenem Arm: 2 Each patient will be on drug therapy for minimum 5 days and maximum 14 days. Age From Age To Gender Year(s) Year(s) Both Inclusion Criteria Details The study should be conducted in patients aged more or equal 18 and equal or less than 65 years if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 1 week after. Intraoperative/postoperative enrollment with confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis. Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory response; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections. Exclusion Criteria Details In, upper age limit is less than equal to 65. Exclusion Criteria Patient is diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal processes in which primary etiology is not likely to be infectious. Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation. Patient has evidence of sepsis with shock not responding to IV fluid challenge or anticipated to require the administration of vasopressors for more than 12 hours. Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization On-site computer system Participant and Investigator Blinded Primary Outcome Outcome Timepoints Clinical Cure as Measured by proportion of patients meeting cure criteria in the microbiological modified Intent-To-Treat analysis 28 to 35 days after start of study drug. page 5 / 7

6 set. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of The proportion of patients with clinical cure in the microbiologically evaluable analysis set. The proportion of patients with clinical cure in the microbiological modified intent-to-treat and microbiologically evaluable analysis sets. The proportion of patients with clinical cure in the clinically evaluable analysis set. The proportion of patients with a favorable per-patient microbiological response in the microbiological modified intent to treat and microbiologically evaluable analysis sets. The proportion of favorable per-pathogen microbiological response in the microbiological modified intent to treat and microbiologically evaluable analysis sets. The favorable per-pathogen microbiologic response by minimum inhibitory concentration (MIC) categories in the microbiological modified intent to treat and microbiologically evaluable analysis sets The favorable per-patient clinical response and favorable per-patient microbiological response for patients infected with ceftazidime-resistant pathogens in the microbiological modified intent to treat and microbiologically evaluable analysis sets. The proportion of patients with a favorable per-pathogen microbiological response for patients infected with ceftazidime-resistant pathogens in the microbiological modified intent to treat and microbiologically evaluable analysis sets The time to first defervescence in the clinically evaluable and microbiologically evaluable analysis sets for patients who have fever at study entry. The safety and tolerability by incidence and severity of adverse events and serious adverse events, vital signs, clinical laboratory tests, ECGs and physical exams. Pharmacokinetics: maximum concentration (Cmax), minimum concentration, area under the plasma concentration time curve at steady state, and terminal half-life Total Sample Size=1106 Sample Size from =125 09/10/ /04/2012 Years=1 28 to 35 days after start of study drug Within 24 hours after last dose of study drug and 42 to 49 days after start of study drug days after start of study drug days after start of study drug. days after start of study drug days after start of study drug 28 to 35 days after start of study drug 28 to 35 days after start of study drug 1 to 14 days after start of study drug study duration (from screening visit (Day -1) through last follow up visit (up to 50 days) Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug page 6 / 7

7 Powered by TCPDF ( PDF of Trial Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Months=10 Days=0 Completed Completed The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections. page 7 / 7