AN OPEN LABEL, BALANCED, RANDOMIZED, MULTICENTRE, MULTI-DOSE, TWO-TREATMENT, PARALLEL, COMPARATIVE PHASE III CLINICAL TRIAL TO DETERMINE THE SAFETY AND EFFICACY OF BIAPENEM 300mg INJECTIONSMANUFACTURED BY BDR PHARMACEUTICALS INTERNATIONALS PVT. LTD., INDIA WITH I-NEM (IMIPENEM 500 mg + CILASTIN 500 mg) INJECTION MANUFACTURED BY GLENMARK PHARMACEUTICALS, INDIAIN HUMAN ADULT, PATIENTS WITH VARIOUS COMPLICATED INFECTIONS.

BDR Pharmaceuticals Internationals Pvt Ltd0 个研究点目标入组 180 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Adult human with a BodyMassIndex ranges between 18.50 kgm2 to 29.99 kgm2
•2.Usually one or more of the following conditions Pyelonephritis ,Indwelling urinary catheter,Obstructive uropathy ,Azotemia, Urinary retention
•3.Patients having two of the following symptoms will be included fever, pelvicpain ,Nausea, vomiting , Dysuria, urinaryfrequency, urinaryurgency ,Costovertebralangle tenderness
•4.Patients who have objective documentation of clinical progression of complicated cUTI while on antibacterial drug therapy.
•5.Patients who received antibacterial drugs for surgical prophylaxis and then developed cUTI.
•6.Urine specimen with evidence of pyuria Dipstick analysis positive for leukocyte esterase
•7.Patients with positive culture report for the cUTI infections.

•1.Receipt of effective antibacterial drug therapy for cUTI for a continuous duration
•2.Patients with suspected or confirmed prostatitis.
•3.Patients with uncomplicated urinary tract infections
•4.Documented history of any hypersensitivity or allergic reaction to any Î²-lactam antibacterial agents.
•5.Women who are pregnant or nursing.
•6.Patient with history of epilepsy.
•7.Has confirmed or suspected pneumonia of viral, fungal or parasitic origin
•8.Abnormal liver function tests ; (SGOT or SGPT) >3 times of the upper limit of the normal range;
•9.Abnormal renal function tests Creatinine clearance <50ml/min
•10.Haematocrit <25% or haemoglobin <6 g/dL
•11.Total Leucocyte count (TLC) <3000 cells/ÂµL,
•12.Platelet count <40,000 cells/ÂµL,
•13.H/O Psychiatric illness
•14.Patients have negative culture report in the cUTI infection.

发起方

BDR Pharmaceuticals Internationals Pvt Ltd