Health Condition 1: null- Lower Respiratory Tract Infections, Urinary Tract Infections and other bacterial infections
Conditions
Interventions
Intervention1: Ciprofloxacin 200mg per 100ml IV: Intervention (Test): Ciprofloxacin Injection IP 200 mg / 100 mL IV administration over 60 min. infusion
Frequency
Intervention: Ciprofloxacin Injectio
Sponsors
Nirma Limited
Eligibility
Inclusion criteria
Inclusion criteria: • 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 ° F) or hypothermia, cough with sputum, dyspnea, crackles, rales, pleuritic pain, dullness of percussion, and leukocytosis or leucopenia
Exclusion criteria
Exclusion criteria: The patients will be excluded based on the following criteria : • History of previous allergy to β-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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Efficacy rate: The proportion of the â??cureâ?? and â??marked improvementâ?? categories will be employed to calculate the overall efficacy rate. 2) Improvement in scores for signs and symptoms in patients of LRTIs, UTIs or other bacterial infections with respect to baseline characteristics. 3) To evaluate safety of the study drug by incidence rates of adverse events. Timepoint: None | — |
Secondary
| Measure | Time frame |
|---|---|
| 2) Improvement in scores for signs and symptoms in patients of LRTIs, UTIs or other bacterial infections with respect to baseline characteristics. 3) To evaluate safety of the study drug by incidence rates of adverse events. Timepoint: None | — |
Countries
India
Contacts
Public ContactDr Chetan Patil
Outcome results
None listed