A clinical trial to study the effects of oral tablets of Fixed-dose Combination of Cefpodoxime 200 mg and Ofloxacin 200 mg in Comparison with Cefpodoxime 200 mg alone in patients with respiratory tract infection [RTI] and typhoid fever

Phase 3

Completed

• Registration Number: CTRI/2010/091/002927
• Lead Sponsor: Akums Drugs & Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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:
oFever
oCough
oProduction of sputum
oLeukocytosis
oRadiographic 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified