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CTRI Number  CTRI/2012/07/002769 [Registered on: 05/07/2012] Trial Registered Retrospectively
Last Modified On: 02/06/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections. 
Scientific Title of Study   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
Modification(s)  
Secondary ID  Identifier 
D4280C00001 dated 5/2/2012  Protocol Number 
NCT01499290  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Arun Sundriyal 
Designation  Associate Director - Clinical Management 
Affiliation  PPD Pharmaceutical Development India Pvt. Ltd. 
Address  PPD Pharmaceutical Development India Pvt Ltd., Vatika City Point, 11th Floor, Sector 25, Mehrauli Gurgaon Road, Gurgaon – 122002 India

Gurgaon
HARYANA
122002
India 
Phone  911244739903  
Fax    
Email  Arun.Sundriyal@ppdi.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Arun Sundriyal  
Designation  Associate Director - Clinical Management  
Affiliation  PPD Pharmaceutical Development India Pvt Ltd. 
Address  PPD Pharmaceutical Development India Pvt Ltd., Vatika City Point, 11th Floor, Sector 25, Mehrauli Gurgaon Road, Gurgaon – 122002 India

Gurgaon
HARYANA
122002
India 
Phone  911244739903  
Fax    
Email  Arun.Sundriyal@ppdi.com  
 
Source of Monetary or Material Support  
AstraZeneca AB, S-151 85 Sodertalje, Sweden 
 
Primary Sponsor  
Name  AstraZeneca 
Address  S-151 85 Sodertalje, Sweden 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Belgium
Brazil
Bulgaria
Czech Republic
India
Israel
Italy
Mexico
Peru
Portugal
Romania
Russian Federation
South Africa
Spain
Taiwan
Thailand
Ukraine
United States of America  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramesh M K  Bangalore Medical College and Research Institute  Victoria Hospital, Centenary Building, Room No-140, Ground Floor, K.R Road , Fort, Bangalore-560002, India
Bangalore
KARNATAKA 
919845168911
918026702386
drmkramesh@gmail.com 
Dr Ashwin Dhanrajji Porwal  Inamdar Multispecialty Hospital  Hospital Building, S.No. 15, Fatima Nagar, Pune-411040, Maharashtra, India
Pune
MAHARASHTRA 
919822347770
912030502275
drashwinporwal@rediffmail.com 
Dr Bharat Kalambe  KEM Hospital Research Centre  3rd Floor, TDH Building, Sardar Moodliar road, Rasta Peth, Pune-411011 , Maharashtra, India
Pune
MAHARASHTRA 
912026141177
912066037403
bkalambe@hotmail.com 
Dr Dipesh Dilipkumar Duttaroy  Medical College And Sir Sayajirao General Hospital Baroda  Department of Surgery, Ground, Floor, New Surgical Block, Anandpura, Indira Avenue, Vadodara - 390001, India
Vadodara
GUJARAT 
919824447713
912652421464
drduttaroy@yahoo.com 
Dr Vijayakumar HM  MS Ramaiah Medical College and Hospitals  MSRIT Post, New BEL Road, Bangalore- 560054, India
Bangalore
KARNATAKA 
919844083643
918040528402
drvkhosmath@gmail.com 
Dr Karthikeyan Chellappan  Noorul Islam Institute of Medical Science (NIMS) and Research Foundation  NIMS MEDICITY, Aralummoodu, Neyyattinkara, Thiruvananthapuram-695 123, Kerala, India.
Thiruvananthapuram
KERALA 
919633252024
9104714018194
nims.research@gmail.com 
Dr Jaikish Jayaraj   PVS Hospital Ltd.  Railway Station Road, Calicut -673002, Kerala, India
Kozhikode
KERALA 
914953011333
914952700785
pvscalicut.cr@gmail.com 
Dr Ajit Naniksingh Kukreja  Ratandeep Surgical Hospital And Endoscopy Clinic  Nakshatra" Second Floor , Ganesh Gali , Maninagar Cross Roads, Ahmedabad-380008,India
Ahmadabad
GUJARAT 
9327055802
9107925465119
inforsh@gmail.com 
Dr Prithi Rodgers  Sahyadri Hospital Hadapsar  G&G Towers, Survey No. 153/A Hissa No. 1 to 4/21, Magarpatta,Pune Solapur Road, Hadapsar, Pune – 411028, India
Pune
MAHARASHTRA 
919673338031
912026890003
prithirodgers@gmail.com 
Dr Manish Surajprakash Bhatnagar  Sterling Hospital  Sterling Hospital Road, Memnagar, Ahmedabad-380052, Gujarat, India.
Ahmadabad
GUJARAT 
919825085059
917940011622
bhatnagarclinic@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Ethical Review Board, M S Ramaiah MedicalMSR Nagar, MSRIT Post, Bangalore - 560054  Approved 
Ethics Committee of Bangalore Medical College and Research Institute K.R Road, Fort, Bangalore  Submittted/Under Review 
Ethics committee of Inamdar Multispecialty Hospital, Hospital Building, S.No. 15, Fatima Nagar, Pune-411040, Maharashtra, India  Submittted/Under Review 
Ethics Committee of KEM Hospital Research Centre,Rasta Peth, Pune-411011, Maharashtra  Submittted/Under Review 
Ethics Committee of Noorul Islam Institute of Medical Sciences,NIMS MEDICITY, Aralummoodu, Neyyattinkara,Thiruvananthapuram-695 123, Kerala  Submittted/Under Review 
Ethics Committee of Sahyadri Hospitals Limited,Erandawane, Karve Road, Pune  Submittted/Under Review 
Ethics Committee of Sterling Hospital, 8th Floor, Sterling Hospital, Sterling Hospital Road, Memnagar, Ahmedabad-380052, Gujarat  Submittted/Under Review 
Ethics Committee of Sukhmani, Ratnam 64, Jainagar,Ahmedabad -380008,Gujarat  Submittted/Under Review 
Institutional Ethics Committee for Human Research Medical College,& SSG Hospital Baroda, Medical College Baroda, Baroda – 390001, Gujarat  Submittted/Under Review 
Institutional Ethics Committee, PVS Hospital (P) Ltd.,Calicut -673002, Kerala  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Complicated Intra-Abdominal Infection ,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Ceftazidime-Avibactam + Metronidazole  Ceftazidime 2000 mg and 500 mg of avibactam + 500 mg of Metronidazole, orally, per day. Each patient will be on drug therapy for minimum 5 days and maximum 14 days.  
Comparator Agent  Meropenem   1 gram of Meropenem, orally, per day Each patient will be on drug therapy for minimum 5 days and maximum 14 days.  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
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
 
 
ExclusionCriteria 
Details  - 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   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Clinical Cure as Measured by proportion of patients meeting cure criteria in the microbiological modified Intent-To-Treat analysis set.  28 to 35 days after start of study drug 
 
Secondary Outcome  
Outcome  TimePoints 
The proportion of patients with clinical cure in the microbiologically evaluable analysis set.  28 to 35 days after start of study drug 
The proportion of patients with clinical cure in the microbiological modified intent-to-treat and microbiologically evaluable analysis sets.  Within 24 hours after last dose of study drug and 42 to 49 days after start of study drug 
The proportion of patients with clinical cure in the clinically evaluable analysis set.  within 24 hours after last dose of study drug, 28 to 35 days after start of study drug and 42 to 49 days after start of study drug 
The proportion of patients with a favorable per-patient microbiological response in the microbiological modified intent to treat and microbiologically evaluable analysis sets  within 24 hours after last dose of study drug, 28 to 35 days after start of study drug and 42 to 49 days after start of study drug 
The proportion of favorable per-pathogen microbiological response in the microbiological modified intent to treat and microbiologically evaluable analysis sets.  within 24 hours after last dose of study drug, 28 to 35 days after start of study drug and 42 to 49 days after start of study drug 
The favorable per-pathogen microbiologic response by minimum inhibitory concentration (MIC) categories in the microbiological modified intent to treat and microbiologically evaluable analysis sets  within 24 hours after last dose of study drug, 28 to 35 days after start of study drug and 42 to 49 days after start of study drug 
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.  28 to 35 days after start of study drug 
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  28 to 35 days after start of study drug 
The time to first defervescence in the clinically evaluable and microbiologically evaluable analysis sets for patients who have fever at study entry.  1 to 14 days after start of study drug 
The safety and tolerability by incidence and severity of adverse events and serious adverse events, vital signs, clinical laboratory tests, ECGs and physical exams.  study duration (from screening visit (Day -1) through last follow up visit (up to 50 days) 
Pharmacokinetics: maximum concentration (Cmax), minimum concentration, area under the plasma concentration time curve at steady state, and terminal half-life  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 
 
Target Sample Size   Total Sample Size="1106"
Sample Size from India="165" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/06/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  01/02/2012 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Brief Summary  

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.

 
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