CTRI/2012/04/002558 [Registered on: 10/04/2012] Trial Registered Retrospectively
Last Modified On:
09/04/2012
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug Other (Specify)
Study Design
Single Arm Study
Public Title of Study
A post marketing surveillance study to evaluate safety and efficacy of fixed dose combination of Ceftriaxone + Sulbactam (Sulbactomax) in patients with various bacterial infections
Scientific Title of Study
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
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Mahip Saluja
Designation
Principal Investigator
Affiliation
Subharti medical college
Address
Associate Professor, department of pulmonary medicine, Subharti medical college Meerut
Meerut UTTAR PRADESH 250001 India
Phone
09837360657
Fax
Email
drmahip@hotmail.com
Details of Contact Person Scientific Query
Name
Dr Mufti Suhail Sayeed
Designation
Vice President(R &D)
Affiliation
Venus Remedies Limited
Address
Venus Remedies Limited Hill Top Industrial Area, EPIP Phase-1 Ex.Jharmajri Village Bhatoli Kalan,Baddi (Dist Solan),Himachal Pradesh:173205 India
Venus Remedies Limited Plot No: 51-52 Industrial Area Phase-1 Panchkula (Haryana):134113, India Solan HIMACHAL PRADESH 173205 India
Phone
09318989301
Fax
01795271272
Email
vp.vmrc@venusremedies.com
Details of Contact Person Public Query
Name
Mr Pushpraj Singh
Designation
A.M. (VCRS-R&D)
Affiliation
Venus Clinical Research Services
Address
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-51-52 Phase-1 Industrial Area, Panchkula Solan HIMACHAL PRADESH 173205 India
Phone
01795302024
Fax
01795271272
Email
cra3@venusremedies.com
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: 173 205, India
Primary Sponsor
Name
Venus Remedies Limited
Address
Plot No-51-52 Industrial Area Phase-1 Panchkula -134113 Haryana (India)
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 5
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Vikram Singh
Aarvy Hospital
Dr. Vikram Singh
Dpartment of Surgery
Aarvy Hospital, 530/18, Civil Lines, Opp. Nehru Stadium, Gurgaon (Haryana) Gurgaon HARYANA
09810869543
vikram@aarvyhospital.com
Dr Parag Sharma
Devnandani Hospital
Dr. Parag Sharma
Department of Medicine,
Devnandani Hospital, Garh Road, Hapur (U.P.) Ghaziabad UTTAR PRADESH
Dr. Dharmendra Kumar Singh
Pushpanjali Hospital, John Hall Road, Civil Lines, Gurgaon (Haryana). Gurgaon HARYANA
09910061615
dkdharmu35@rediffmail.com
Dr Mahip Saluja
Subharti Medical College & Hospital
Dr. Mahip Saluja
Professor, Department of Respiratory Medicine
Subharti Medical College and Hospital, Meerut (U.P) Meerut UTTAR PRADESH
09837360657
drmahip@hotmail.com
Details of Ethics Committee
No of Ethics Committees= 5
Name of Committee
Approval Status
EC_CKTRI_Approval1
Approved
EC_CKTRI_Approval3
Approved
EC_CKTRI_Approval4
Approved
EC_CKTRI_Approval6
Approved
EC_CKTRI_Approval8
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
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 / Comparator Agent
Type
Name
Details
Intervention
SULBACTOMAX
1.5 GM BD I.V. Total Duration of Therapy for 3-10 days
Inclusion Criteria
Age From
1.00 Day(s)
Age To
99.00 Year(s)
Gender
Both
Details
Inclusion criteria for LRTI:
•All age groups included (Pediatric, Adult and Geriatric)
•Subject is willing to participate as evidenced by signing the written informed
consent form. LAR shall sign the ICF in case of illiterate subjects.
•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:
•All age groups included (Pediatric, Adult and Geriatric)
•Subject is willing to participate as evidenced by signing the written informed
consent form. LAR shall sign the ICF in case of illiterate subjects.
•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:
•All age groups included (Pediatric, Adult and Geriatric)
•Subject is willing to participate as evidenced by signing the written informed
consent form. LAR shall sign the ICF in case of illiterate subjects or subjects
with impaired consciousness.
•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:
•All age groups included (Pediatric, Adult and Geriatric)
•Subject is willing to participate as evidenced by signing the written informed
consent form. LAR shall sign the ICF in case of illiterate subjects or subjects
with impaired consciousness.
•Clinical history, signs, symptoms and laboratory investigations suggestive of
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:
•All age groups included (Pediatric, Adult and Geriatric)
•Subject is willing to participate as evidenced by signing the written informed
consent form. LAR shall sign the ICF in case of illiterate subjects or subjects
with impaired consciousness.
•Clinical history, signs, symptoms and laboratory investigations suggestive of
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:
•All age groups included (Pediatric, Adult and Geriatric)
•Subject is willing to participate as evidenced by signing the written informed
consent form. LAR shall sign the ICF in case of illiterate subjects or subjects
with impaired consciousness.
•Clinical history, signs, symptoms and laboratory investigations suggestive of
gonorrhoea, judged by the treating physician empirically or on the basis of
culture to require treatment with Sulbactomax.
Inclusion criteria for otitis media:
•All age groups included (Pediatric, Adult and Geriatric)
•Subject is willing to participate as evidenced by signing the written informed
consent form. LAR shall sign the ICF in case of illiterate subjects or subjects
with impaired consciousness.
•Clinical history, signs, symptoms and laboratory investigations suggestive of
otitis media, judged by the treating physician empirically or on the basis of
culture to require treatment with Sulbactomax.
Inclusion criteria for surgical prophylaxis:
•All age groups included (Pediatric, Adult and Geriatric)
•Subject is willing to participate as evidenced by signing the written informed
consent form. LAR shall sign the ICF in case of illiterate subjects or subjects
with impaired consciousness.
•Pre-, peri-, or postoperative antibiotic prophylaxis
Inclusion criteria for Enteric fever (Typhoid fever)
•All age groups included (Pediatric, Adult and Geriatric)
•Subject is willing to participate as evidenced by signing the written informed
consent form. LAR shall sign the ICF in case of illiterate subjects or subjects
with impaired consciousness.
•Clinical history, signs, symptoms and laboratory investigations suggestive of
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:
•All age groups included (Pediatric, Adult and Geriatric)
•Subject is willing to participate as evidenced by signing the written informed
consent form. LAR shall sign the ICF in case of illiterate subjects or subjects
with impaired consciousness.
•Clinical history, signs, symptoms and laboratory investigations suggestive of
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.
ExclusionCriteria
Details
Exclusion criteria for LRTI:
•Any known hypersensitivity to active ingredients of SulbactomaxTM.
•Subject undergoing treatment with other active drug.
•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.
•Any known hypersensitivity to active ingredients of SulbactomaxTM.
•Subject undergoing treatment with other active drug.
•Sexually transmitted diseases (STDs).
•Sterile pyuria.
•Pelvic inflammatory disease.
•Chemical cystitis.
•Neoplasms of the Urinary tract.
Exclusion criteria for bacterial meningitis:
•Any known hypersensitivity to active ingredients of SulbactomaxTM.
•Subject undergoing treatment with other active drug 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:
•Any known hypersensitivity to active ingredients of SulbactomaxTM.
•Subject undergoing treatment with other active drug of the cephalosporin
class
•Pseudosepsis
Exclusion criteria for skin and soft tissue infection:
•Any known hypersensitivity to active ingredients of SulbactomaxTM.
•Subject undergoing treatment with other active drug
•Cutaneous neoplasms
Exclusion criteria for Gonorrhoea:
•Any known hypersensitivity to active ingredients of SulbactomaxTM.
•Subject undergoing treatment with other active drug
Exclusion criteria for otitis media:
•Any known hypersensitivity to active ingredients of Sulbactomax.
•Subject undergoing treatment with other active drug
Exclusion criteria for surgical prophylaxis:
•Any known hypersensitivity to active ingredients of Sulbactomax.
•Subject undergoing treatment with other active drug
Exclusion criteria for Enteric fever (Typhoid fever) :
•Any known hypersensitivity to active ingredients of Sulbactomax.
•Subject undergoing treatment with other active drug
Exclusion criteria for bone and joint infections:
•Any known hypersensitivity to active ingredients of Sulbactomax.
•Subject undergoing treatment with other active drug of the cephalosporin class.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To obtain safety information on the use of SulbactomaxTM (ceftriaxone + sulbactam) in subjects 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.
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.
Secondary Outcome
Outcome
TimePoints
To monitor the therapeutic outcome of SulbactomaxTM (FDC of ceftriaxone + sulbactam) in subjects 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.
Observed of Clinical Cure rate at the end of treatment
Target Sample Size
Total Sample Size="2500" Sample Size from India="2500" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Post Marketing Surveillance
Date of First Enrollment (India)
31/03/2011
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
The 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 SulbactomaxTM
(ceftriaxone + sulbactam) in subjects 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 SulbactomaxTM (FDC of
ceftriaxone + sulbactam) in subjects 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.