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
Conditions
Interventions
Intervention1: SULBACTOMAX: 1.5 GM BD I.V. Total Duration of Therapy for 3-10 days
Intervention2: SULBACTOMAX: 1.5 GM BD I.V. Total Duration of Therapy for 3-10 days
Sponsors
Venus Remedies Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactMr Pushpraj Singh
Venus Remedies Limited
Outcome results
None listed