To evaluate the efficacy and safety of two antibiotics in treatment of patients with lower respiratory tract infections
- Conditions
- Health Condition 1: null- Patients with Lower Respiratory Tract Infections
- Registration Number
- CTRI/2011/09/001991
- Lead Sponsor
- Abbott Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 220
1.Male and Females aged 18 years and above.
2.Patients with clinical signs and symptoms of lower respiratory tract infection.
3.Normal Chest X-ray.
4.Patients must give written informed consent after reading the Patient Information and Consent Form and having had the opportunity to discuss the study with the Investigator.
5.Patient willing to follow up and comply with the Protocol requirements.
1.Patients with Upper Respiratory Tract Infection (URTI).
2.Patients with a known allergy to any of ingredients of investigational product and/or comparator product.
3.Patients allergic to cephalosporin group of antibiotics.
4.Patients with a history of allergic reactions to any penicillin.
5.Patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with cefpodoxime and / or Clavulanic acid.
6.Pregnant and lactating females.
7.Patient not willing to participate in the trial or not in position to give the informed consent.
8.Immunocompromized patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess and compare the decrease in severity of symptoms from baseline to the end of treatmentTimepoint: Baseline, Day 3 , Day 5 and Day 7
- Secondary Outcome Measures
Name Time Method â?¢Improvement in general health and patients satisfaction by assessing the Overall assessment of efficacy, tolerability and safety of treatment by the investigator and patientTimepoint: Baseline, Day 3 , day 5 and day 7