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To evaluate efficacy and safety of three drug combinations in patients with community acquired pneumonia and acute exacerbation of chronic bronchitis

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/01/002347
Enrollment
80
Registered
2012-01-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- community acquired pneumonia and acute exacerbation of chronic bronchitis

Interventions

Intervention1: FDC containing Levofloxacin 250 mg + Cefpodoxime 200 tablet: One tablet twice daily for 7 days Control Intervention1: Levofloxacin 500 mg tablet: One tablet once daily for 7 days Contro

Sponsors

Dr Sharif Tadvi
Lead Sponsor

Eligibility

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Decrease in severity of clinical signs and symptoms from baseline to the end of treatment. Radiological response to treatment. Microbiological response to the treatment. Timepoint: 14 days

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Sharif Tadvi
shariftadvi55@gmail.com9321555561

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026