An Open-Label clinical study to evaluate efficacy and safety of Ciprofloxacin Injection manufactured by Nirma Limited for the treatment of Lower Respiratory Tract Infections, Urinary Tract Infections and other bacterial infections

irma Limited0 个研究点目标入组 30 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Patient within 18 â?? 65 years of age ( both inclusive)
•Women of child bearing age with a normal menstrual cycle and a negative pregnancy test.
•Patients suffering from urinary tract infections (UTIs) with at least two of the following: fever, urinary irritation symptoms (dysuria, frequency, and urgency), suprapubic pain, costovertebral tenderness or flank pain, or the presence of more than five leukocytes per high-power field in centrifuged sediment.
•Patients suffering from lower respiratory tract infections (LRTIs) had to have at least two of the following: fever ( > 98.6 Â° F) or hypothermia, cough with sputum, dyspnea, crackles, rales, pleuritic pain, dullness of percussion, and leukocytosis or leucopenia

•The patients will be excluded based on the following criteria :
•History of previous allergy to Î²-lactam antibiotics or history of seizure.
•History of consumption of any other antimicrobial agent within last 72 hours.
•New drug trial in the three previous months.
•History of severe cardiac, renal or haematological impairment.
•Patients with continuing history of alcohol and / or drug abuse.
•Increased hepatic or renal enzyme levels >3 times of the upper limit of the normal range.
•Patient with terminal malignancy or psychiatric illness.
•Pregnant or nursing woman.

发起方

irma Limited