A clinical study to evaluate efficacy and safety of Metronidazole Injection manufactured by Nirma Limited for the treatment of Lower Respiratory Tract Infections, Intra abdominal infections and other bacterial infections.
- Conditions
- Health Condition 1: null- Lower Respiratory Tract Infections, Intra abdominal infections and other bacterial infections
- Registration Number
- CTRI/2012/09/002988
- Lead Sponsor
- irma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
•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.
•Patient suffering from Intra-Abdominal infection had to have signs/ symptoms such as abdominal pain, tenderness etc. A case will be defined as an intra-abdominal abscess or peritoneal fluid culture that will be positive for enterococcus or an enterococcal bacteraemia in association with an intra-abdominal source of infection.
•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.
The patients will be excluded based on the following criteria :
1.History of previous allergy to β-lactam antibiotics or history of seizure.
2.History of consumption of any other antimicrobial agent within last 72 hours.
3.New drug trial in the three previous months.
4.History of severe cardiac, renal or haematological impairment.
5.Patients with continuing history of alcohol and / or drug abuse.
6.Increased hepatic or renal enzyme levels >3 times of the upper limit of the normal range.
7.Patient with terminal malignancy or psychiatric illness.
8.Pregnant or nursing woman.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Efficacy rate: <br/ ><br>The proportion of the â??cureâ?? and â??marked improvementâ?? categories will be employed to calculate the overall efficacy rate. <br/ ><br>Timepoint: None
- Secondary Outcome Measures
Name Time Method 2) Improvement in scores for signs and symptoms in patients of LRTIs, Intra abdominal infections or other bacterial infections with respect to baseline characteristics. <br/ ><br>3) To evaluate safety of the study drug by incidence rates of adverse events. <br/ ><br>Timepoint: None