Health Condition 1: null- Patients with Lower Respiratory Tract Infections
Conditions
Interventions
Intervention1: FDC of Cefpodoxime + Clavulanic acid: Cefpodoxime 200 mg + Clavulanic acid 125 mg - One tablet twice daily for 7 days
Rout of Administration- Oral
Control Intervention1: Cefpodoxime pr
Sponsors
Abbott Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactMr Manoj Prabhu
Abbott Healthcare Pvt Ltd
Outcome results
None listed