None listed
Conditions
Interventions
Intervention1: Cefpodoxime 200 mg and Ofloxacin 200 mg Tablet: 200mg and 200 mg
Control Intervention1: Cefpodoxime 200 mg tablet: 200mg
Sponsors
Akums Drugs & Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria:  All subjects with duly filled and signed in ICFs [Informed Consent Forms]  Male and female outpatients ³ 18 years of age.  Clinical diagnosis of respiratory tract infection [RTI] by virtue of following signs & symptoms: o Fever o Cough o Production of sputum o Leukocytosis o Radiographic abnormality  Sputum/ urine culture defining presence of gram-negative and gram-positive bacteria with susceptibility to cefpodoxime and ofloxacin [Culture specimens will be processed in an automatic device (BacT Alert System, Organon Teknika Corp., UK].  Formerly healthy patients, with functional gastrointestinal tract, and without intestinal complications as perforation or extraintestinal complications like lymphadenitis, arthritis, multifocal osteomyelitis, brain abscesses, pneumonia or sepsis  If female, using birth control  Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved Informed Consent Form.
Exclusion criteria
Exclusion criteria:  Patients unwilling to sign on ICF  Patients with hypersensitivity to cephalosporins or fluoroquinolones  Patient who severe complications of RTI/ Typhoid fever  Patients having received antibiotic medication within 14 days prior to dosing  Patients who test positive for hepatitis B, hepatitis C, HIV or human leucocyte antigen B-27  An uncontrolled, unstable clinically significant medical condition  Clinically significant abnormal laboratory, vital sign or ECG findings at screening;  A positive serum pregnancy test at screening, or the intention to become pregnant within the next 30 days;  Patient with history of bronchial asthma, bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD) and cystic fibrosis.  Patient with history of gastritis, hyperacidity, peptic ulcer disease  Judged by the principal investigator (PI) to be unable to reliably respond to the questionnaire based on clinically significant cognitive impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this trial is to evaluate any difference between oral tablets of the Fixed-dose Combination of Cefpodoxime 200 mg and Ofloxacin 200 mg with cefpodoxime 200 mg oral tablets in patients with respiratory tract infection [RTI] and typhoid fever in terms of efficacy by virtue of symptomatic improvement during the ten-day study durationTimepoint: 10 day | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this trial is to evaluate any difference between oral tablets of the Fixed-dose Combination of Cefpodoxime 200 mg and Ofloxacin 200 mg with cefpodoxime 200 mg oral tablets in patients with respiratory tract infection [RTI] and typhoid fever in terms of safety by virtue of comparing adverse events in each arm throughout the trial duration and clinical chemistry profiles at the baseline and end-of-study.Timepoint: 10 days | — |
Countries
India
Contacts
Public ContactDr. Nitin M Rathod
Outcome results
None listed