A post marketing surveillance study to evaluate safety and efficacy of fixed dose combination of Ceftriaxone + Sulbactam (Sulbactomax) in patients with various bacterial infections
- Conditions
- Health Condition 1: null- LRTI, UTI, BACTERIAL MENINGITIS, BACTERIAL SEPSIS, SKIN AND SOFT TISSUE INFECTION, GONORRHOEA, OTITIS MEDIA, SURGICAL PROPHYLAXIS, ENTERIC FEVER (TYPHOID FEVER), BONE AND JOINT INFECTIONS
- Registration Number
- CTRI/2012/04/002558
- Lead Sponsor
- Venus Remedies Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 2500
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
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: 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 Measures
Name Time Method 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.Timepoint: Observed of Clinical Cure rate at the end of treatment