A Phase III, Multicenter, Randomized, Open Label, Clinical study To evaluate Efficacy and Safety of two strengths of Meropenem Plus Tazobactam For the Treatment of Patients with Gram Negative Infection Including Pseudomonas aeruginosa

Aqua Vitoe Laboratories0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

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•1.Written informed consent from the patient.
•2.Male or Female patients aged greater than or equals to 18 years.
•3.Patientâ??s culture defining presence of gram negative infection including Pseudomonas aeruginosa.
•4.Patients who failed to prior antibacterial treatment can be enrolled but must have a positive culture test.
•5.Willingness to comply with the study schedule and procedures.

•1.Patients with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
•2.Baseline pathogens known to be resistant to study agents at the study entry.
•3.Concurrent confounding infection.
•4.Patients who consume alcohol should not be enrolling into the study.
•5.History of anaphylaxis or serious allergy to either study agent or antibiotic agents in the Î²-lactam class.
•6.Patients having low likelihood of either treatment response or survival to follow-up visit.
•7.Patients with ALT or AST more than six times the upper limit of normal (ULN).
•8.Patients with neutropenia ( 1000 x million neutrophils/L).
•9.A history of significant underlying disease or of hypersensitivity to either of the trial drugs.
•10.Patient is a female who is pregnant or willing to get pregnant, no ready to use contraceptive measures during the trial period of breast feeding.
•11.Hypovolaemia or dehydration from any cause.
•12.Participation in any other clinical trial during last 30 days.

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