CTRI/2012/04/002558招募中Unknown
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
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 5
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •â€¢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.
- •â€¢Subject has a clinically suspected and /or bacteriologically documented urinary tract infections (upper or lower) with or without complications.
- •â€¢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.
- •â€¢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.
- •â€¢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.
- •â€¢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.
- •â€¢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.
- •â€¢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.
- •â€¢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.
- •â€¢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.
排除标准
- •Exclusion criteria for LRTI: •Any known hypersensitivity to active ingredients of SulbactomaxTM.
- •â€¢Subject undergoing treatment with other active drug.
- •â€¢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.
- •â€¢Any known hypersensitivity to active ingredients of SulbactomaxTM.
- •â€¢Sexually transmitted diseases (STDs).
- •â€¢Sterile pyuria.
- •â€¢Pelvic inflammatory disease.
- •â€¢Chemical cystitis.
- •â€¢Neoplasms of the Urinary tract.
- •Exclusion criteria for bacterial meningitis: •Any known hypersensitivity to active ingredients of SulbactomaxTM.
- •â€¢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.
- •â€¢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.
- •â€¢Subject undergoing treatment with other active drug •Cutaneous neoplasms Exclusion criteria for Gonorrhoea: •Any known hypersensitivity to active ingredients of SulbactomaxTM.
- •â€¢Subject undergoing treatment with other active drug Exclusion criteria for otitis media: •Any known hypersensitivity to active ingredients of Sulbactomax.
- •â€¢Subject undergoing treatment with other active drug Exclusion criteria for surgical prophylaxis: •Any known hypersensitivity to active ingredients of Sulbactomax.
- •â€¢Subject undergoing treatment with other active drug Exclusion criteria for Enteric fever (Typhoid fever) : •Any known hypersensitivity to active ingredients of Sulbactomax.
- •â€¢Subject undergoing treatment with other active drug Exclusion criteria for bone and joint infections: •Any known hypersensitivity to active ingredients of Sulbactomax.
- •â€¢Subject undergoing treatment with other active drug of the cephalosporin class.
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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)
研究者
研究点 (5)
Loading locations...
相似试验
招募中
Unknown
An observational study to evaluate the safety and tolerability of Amphotericin B Lipid suspension in patients with Invasive Fungal Infections.CTRI/2017/08/009429Cipla Ltd250
招募中
Unknown
An Observational Study to Evaluate the Safety and Tolerability of Minocycline Hydrochloride Injection in Indian Patients with Multi Drug Resistant Gram-Negative Bacterial Infections.CTRI/2018/04/013319Cipla Ltd50
已完成
4 期
An open phase IV study for Indian patients (in between 18-65 years) suffering from Insomnia.CTRI/2022/08/045113Eisai Pharmaceuticals India Pvt Ltd110
已完成
Unknown
Evaluation of safety of Effectiveness And Safety Of An Appetite Stimulating Tonic In Children.CTRI/2023/10/058301Abbott Healthcare Private Limited380
已完成
不适用
A Open Label, Post Marketing Surveillance Study Following Transfusion of INTERCEPT Platelet ComponentsTransfusion Related Acute Lung InjuryNCT02549222Cerus Corporation2,291