CTRI/2012/04/002558招募中4 期
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
- 4 期
- 状态
- 招募中
- 入组人数
- 2,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
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.
- •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
- 另有 1 项未显示
排除标准
- •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
- •Noninfectious meningitis, including medication-induced meningeal
- •inflammation
- •Meningeal carcinomatosis
- •Brain Neoplasms
- •CNS vasculitis
- •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
- •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.
- 另有 10 项未显示
研究者
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