Health Condition 1: J069- Acute upper respiratory infection,unspecified Health Condition 2: J189- Pneumonia, unspecified organism Health Condition 3: null- Respiratory tract infections (RTI) Health Condition 4: J22- Unspecified acute lower respiratory infection
Conditions
Interventions
Intervention1: Faropenem sodium 300 mg extended-release tablets: one tablet twice in a day for at least 7 days and for a maximum of 14 days
Control Intervention1: Faropenem sodium 200 mg conventional
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients between 18-65 years of age. 2. Patients with established infection of the upper or lower respiratory tract (e.g. acute bacterial exacerbation of chronic bronchitis, acute sinusitis and/or community acquired pneumonia) 3. Informed consent of the patient/relative.
Exclusion criteria
Exclusion criteria: 1. Pregnancy/Lactation/Less than 18 years of age. 2. Grossly abnormal liver or kidney function tests or significant hematological abnormalities. 3. History of known hypersensitivity to any of the penems, penicillincs, cephalosporins or other beta-lactams. 4. Patients with CNS disorders or epilepsy or history of other factors that can predispose to seizures. 5. Patients with serious infections requiring hospitalization or life-threatening in nature where monotherapy with Faropenem sodium would be considered inadequate. 6. Patients receiving any other antibiotic/antibacterial agent in the previous 2/3 days prior to enrolment in the study. 7. Patients with any other serious concurrent illness or malignancy. 8. Patients with continuing history of alcohol and / or drug abuse. 9. Participation in another clinical trial in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical success rate in each of the infections as judged by either complete cure at the end of the treatment phase or significant improvement with no need for further antibiotic therapy at the end of the treatment phase.Timepoint: 7 days & 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The bacterial eradication rates observed in these patients at the end of therapy 2) Overall assessment of efficacy given to the study medication by the investigator at the end of the study Timepoint: 7 days & 14 days | — |
Countries
India
Contacts
Public ContactDr Ravindra Mittal
Outcome results
None listed