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1 Clinical Trial Details (PDF Generation Date :- Mon, 17 Dec :09:15 GMT) CTRI Number Last Modified On 09/04/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/04/ [Registered on: 10/04/2012] - Trial Registered Retrospectively No PMS Drug Other (Specify) Single Arm Trial A post marketing surveillance study to evaluate safety and efficacy of fixed dose combination of Ceftriaxone + Sulbactam (Sulbactomax) in patients with various bacterial infections A open label, observational, multicenter, prospective, post marketing surveillance study (PMS) to evaluate safety and efficacy of sulbactomax (FDC of Ceftriaxone + Sulbactam) in patients with various bacterial infections Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Designation Affiliation Details of Principal Investigator Dr Mahip Saluja Principal Investigator Subharti medical college Phone Fax Designation Affiliation Associate Professor, department of pulmonary medicine, Subharti medical college Meerut Meerut drmahip@hotmail.com Details Contact Person (Scientific Query) Dr Mufti Suhail Sayeed Vice President(R &D) Venus Remedies Limited Phone Fax Designation Affiliation Venus Remedies Limited Hill Top Industrial Area, EPIP Phase-1 Ex.Jharmajri Village Bhatoli Kalan,Baddi (Dist Solan),Himachal Pradesh: Venus Remedies Limited Plot No: Industrial Area Phase-1 Panchkula (Haryana):134113, Solan HIMACHAL PRADESH vp.vmrc@venusremedies.com Details Contact Person (Public Query) Mr Pushpraj Singh A.M. (VCRS-R&D) Venus Clinical Research Services Venus Remedies Limited Hill Top Industrial Estate Near Jharmajri, E.P.I.P., Phase-I, (Extention) Village Bhatoli Kalan Baddi, Himachal Pradesh Venus Remedies Limited, Plot no Phase-1 Industrial page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Area, Panchkula Solan HIMACHAL PRADESH Phone Fax Source of Monetary or Material Support > Venus Remedies Limited Hill Top Industrial Estate Near Jharmajri, E.P.I.P., Phase-I, (Extention) Village Bhatoli Kalan Baddi, Himachal Pradesh Pin code: , Type of Sponsor List of Countries of Principal Investigator Primary Sponsor Details Venus Remedies Limited Plot No Industrial Area Phase-1 Panchkula Haryana () Pharmaceutical industry-n of Site Site Phone/Fax/ Dr Vikram Singh Aarvy Hospital Dr. Vikram Singh Dpartment of Surgery Aarvy Hospital, 530/18, Civil Lines, Opp. Nehru Stadium, Gurgaon (Haryana) Gurgaon HARYANA Dr Parag Sharma Devnandani Hospital Dr. Parag Sharma Department of Medicine, Devnandani Hospital, Garh Road, Hapur (U.P.) Ghaziabad Dr Arvind Jain Dr. Arvind Jain Clinic Dr. Arvind Jain Consultant Physician, 4/18, Bhag Farzana, Civil Lines, Agra (U.P.) Agra Dr Dharmendra Kumar Singh Dr Mahip Saluja Pushpanjali Hospital Subharti Medical College & Hospital Dr. Dharmendra Kumar Singh Pushpanjali Hospital, John Hall Road, Civil Lines, Gurgaon (Haryana). Gurgaon HARYANA Dr. Mahip Saluja Professor, Department of Respiratory Medicine Subharti Medical om com om page 2 / 7

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria College and Hospital, Meerut (U.P) Meerut of Committee Approval Status Date of Approval Is Independent Ethics Committee? EC_CKTRI_Approval1 Approved 11/11/2011 No EC_CKTRI_Approval3 Approved 30/08/2011 Yes EC_CKTRI_Approval4 Approved 30/08/2011 Yes EC_CKTRI_Approval6 Approved 30/08/2011 Yes EC_CKTRI_Approval8 Approved 30/08/2011 Yes Status Health Type Patients Date No Date Specified Condition Type Details LRTI, UTI, BACTERIAL MENINGITIS, BACTERIAL SEPSIS, SKIN AND SOFT TISSUE INFECTION, GONORRHOEA, OTITIS MEDIA, SURGICAL PROPHYLAXIS, ENTERIC FEVER (TYPHOID FEVER), BONE AND JOINT INFECTIONS Intervention SULBACTOMAX 1.5 GM BD I.V. Total Duration of Therapy for 3-10 days Age From Age To Gender Details 1.00 Day(s) Year(s) Both Inclusion Criteria Inclusion criteria for LRTI: consent form. LAR shall sign the ICF in case of illiterate. New or increased respiratory signs or symptoms (i.e., cough, sputum production, dyspnea, auscultatory findings of abnormal breath sounds and rales, pleuritic chest pain) with or without inflammatory signs Presence of an abnormal chest x-ray (CXR) Acute exacerbations of Chronic obstructive pulmonary disease (COPD) due to infection Inclusion criteria for UTI: consent form. LAR shall sign the ICF in case of illiterate. Subject has a clinically suspected and /or bacteriologically documented urinary tract infections (upper or lower) with or without complications. Clinical signs with one or more symptoms of UTI (e.g., dysuria, frequency, urgency, suprapubic / flank pain, pyuria). Inclusion criteria for bacterial meningitis: page 3 / 7

4 consent form. LAR shall sign the ICF in case of illiterate or Clinical history, signs and symptoms of acute or sub-acute bacterial meningitis, judged by the treating physician empirically or on the basis of CSF culture to be requiring treatment with Sulbactomax. Inclusion criteria for Bacterial Sepsis: consent form. LAR shall sign the ICF in case of illiterate or symptomatic bacteremia, with or without organ dysfunction, judged by the treating physician empirically or on the basis of blood culture to require treatment with Sulbactomax. Inclusion criteria for skin and soft tissue infection: consent form. LAR shall sign the ICF in case of illiterate or skin and soft tissue infection, judged by the treating physician empirically or on the basis of blood culture to require treatment with Sulbactomax. Inclusion criteria for Gonorrhoea: consent form. LAR shall sign the ICF in case of illiterate or gonorrhoea, judged by the treating physician empirically or on the basis of culture to require treatment with Sulbactomax. Inclusion criteria for otitis media: consent form. LAR shall sign the ICF in case of illiterate or otitis media, judged by the treating physician empirically or on the basis of culture to require treatment with Sulbactomax. Inclusion criteria for surgical prophylaxis: page 4 / 7

5 consent form. LAR shall sign the ICF in case of illiterate or Pre-, peri-, or postoperative antibiotic prophylaxis Inclusion criteria for Enteric fever (Typhoid fever) consent form. LAR shall sign the ICF in case of illiterate or enteric fever, judged by the treating physician empirically or on the basis of culture to require treatment with Sulbactomax. Inclusion criteria for bone and joint infections: consent form. LAR shall sign the ICF in case of illiterate or bone and joint infections (osteomyelitis, septic arthritis, etc.), judged by the treating physician empirically or on the basis of culture to require treatment with Sulbactomax. Exclusion Criteria Details Exclusion Criteria Exclusion criteria for LRTI:. Pulmonary embolism Active pulmonary tuberculosis Aspiration pneumonia Acute bronchial asthma without signs of lower respiratory tract infection Pulmonary oedema Subdiaphragmatic collection Cryptogenic Organising Pneumonitis (COP) and BOOP (Bronchiolitis Obliterans Organising Pneumonia) Occupational lung diseases Lung Neoplasms Exclusion criteria for UTI: Subject has complete obstruction of any portion of the urinary tract.. Sexually transmitted diseases (STDs). Sterile pyuria. Pelvic inflammatory disease. Chemical cystitis. Neoplasms of the Urinary tract. Exclusion criteria for bacterial meningitis: page 5 / 7

6 Method of Generating Random Sequence Method of Concealment Blinding/Masking Open Label of the cephalosporin class Noninfectious meningitis, including medication-induced meningeal inflammation Meningeal carcinomatosis Brain Neoplasms CNS vasculitis Stroke Encephalitis Leptospirosis Subdural empyema Subarachnoid Hemorrhage Brain Abscess Delirium tremens (DT) All causes of altered mental status and coma except meningitis Exclusion criteria for Bacterial Sepsis: of the cephalosporin class Pseudosepsis Exclusion criteria for skin and soft tissue infection: Cutaneous neoplasms Exclusion criteria for Gonorrhoea: Exclusion criteria for otitis media: Sulbactomax. Exclusion criteria for surgical prophylaxis: Sulbactomax. Exclusion criteria for Enteric fever (Typhoid fever) : Sulbactomax. Exclusion criteria for bone and joint infections: Sulbactomax. of the cephalosporin class. Primary Outcome Outcome Timepoints To obtain safety information on the use of SulbactomaxTM (ceftriaxone + sulbactam) in with Lower respiratory tract, Urinary tract infections, Bacterial meningitis, Bacterial Sepsis, Skin and soft tissue infection, Gonorrhoea, Otitis media, Surgical prophylaxis, Enteric fever (Typhoid fever), Bone and joint the safety data will be gather from each patients receiving sulbactomax as per study calender. Study outcome will be measured on yearly basis or completion of specified patients in the PMS study. page 6 / 7

7 Powered by TCPDF ( PDF of Trial infections. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary The To monitor the therapeutic outcome of SulbactomaxTM (FDC of ceftriaxone + sulbactam) in with Lower respiratory tract,urinary tract infections, Bacterial meningitis, Bacterial Sepsis, Skin and soft tissue infection, Gonorrhoea, Otitis media, Surgical prophylaxis, Enteric fever (Typhoid fever), Bone and joint infections. Total Sample Size=2500 Sample Size from =2500 Post Marketing Surveillance 31/03/2011 No Date Specified Years=1 Months=6 Days=0 Open to Recruitment Observed of Clinical Cure rate at the end of treatment study is open labeled, observational, multicenter, prospective, post marketing surveillance study (PMS) to evaluate safety and efficacy of Sulbactomax in patients suffering from various bacterial infections. Primary out come measures will be obtain safety information on the use of Sulbactomax TM (ceftriaxone + sulbactam) in with Lower respiratory tract, Urinary tract infections, Bacterial meningitis, Bacterial Sepsis, Skin and soft tissue infection, Gonorrhoea, Otitis media, Surgical prophylaxis, Enteric fever (Typhoid fever), Bone and joint infections. i.e. Number of patients cured on completion of treatment. Secondary Outcome shall measure to monitor the therapeutic outcome of Sulbactomax TM (FDC of ceftriaxone + sulbactam) in with Lower respiratory tract,urinary tract infections, Bacterial meningitis, Bacterial Sepsis, Skin and soft tissue infection, Gonorrhoea, Otitis media, Surgical prophylaxis, Enteric fever (Typhoid fever), Bone and joint infections. Primary end point will measure to Incidence of adverse events (AEs) and incidence of discontinuation due to AEs. Secondary end point will measure to Observed of Clinical Cure rate at the end of treatment. page 7 / 7