A post marketing surveillance study to evaluate safety and efficacy of fixed dose combination of Ceftriaxone + Sulbactam (Sulbactomax) in patients with various bacterial infections

Not Applicable

Recruiting

• Conditions: 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

The study is open labeled, observational, multicenter, prospective, post marketing surveillance study (PMS) to evaluate safety and efficacy of Sulbactomax inpatients suffering from various bacterial infections. Primary out comemeasures will be obtain safety information on the use of SulbactomaxTM (ceftriaxone + sulbactam) in subjects with Lower respiratorytract, Urinary tract infections, Bacterialmeningitis, 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 tomonitor the therapeutic outcome of SulbactomaxTM (FDC ofceftriaxone + sulbactam) in subjects with Lower respiratory tract,Urinary tract infections, Bacterialmeningitis, 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) andincidence of discontinuation due to AEs. Secondary end point will measure to Observed of Clinical Cure rate at theend of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-31
• Last Update Posted: 2012-09-04

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 2500

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.
• •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.
• •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.
• •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.
• 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.
• •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.
• •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.
• •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.
• •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.

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.
• •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.	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.	Observed of Clinical Cure rate at the end of treatment

Trial Locations

Locations (5)

Aarvy Hospital; 🇮🇳 Gurgaon, HARYANA, India

Devnandani Hospital; 🇮🇳 Ghaziabad, UTTAR PRADESH, India

Dr. Arvind Jain Clinic; 🇮🇳 Agra, UTTAR PRADESH, India

Pushpanjali Hospital; 🇮🇳 Gurgaon, HARYANA, India

Subharti Medical College & Hospital; 🇮🇳 Meerut, UTTAR PRADESH, India

Aarvy Hospital

🇮🇳Gurgaon, HARYANA, India

Dr Vikram Singh

Principal investigator

09810869543

vikram@aarvyhospital.com