CTRI/2012/01/002347
Not yet recruiting
Phase 4
Assessment of the efficacy and safety of the fixed-dose combination of levofloxacin plus cefpodoxime versus levofloxacin, cefpodoxime and amoxicillin/clavulanic acid monotherapy in patients with community acquired pneumonia and acute exacerbation of chronic bronchitis
Dr Sharif Tadvi0 sites80 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- community acquired pneumonia and acute exacerbation of chronic bronchitis
- Sponsor
- Dr Sharif Tadvi
- Enrollment
- 80
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects 18 \-65 years age of either sex who are able to give voluntary written informed consent and willing to come for follow up.
- •Patients with clinical signs and symptoms of CAP or AECB as per investigators discretion.
- •Chest X\-ray findings suggestive of CAP or AECB
Exclusion Criteria
- •Subjects requiring hospitalization
- •Subjects with known or suspected hypersensitivity to penicillins, levofloxacin, cefpodoxime or any the constituents of the formulation.
- •Subjects who have received antimicrobial therapy within 7 days prior to enrollment.
- •Patient who severe complications of RTI.
- •An uncontrolled, unstable clinically significant medical condition;
- •Clinically significant abnormal laboratory, vital sign or ECG findings at screening.
- •Pregnant and lactating females.
Outcomes
Primary Outcomes
Not specified
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