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

• Conditions: Respiratory Tract Infection [RTI] and Typhoid Fever

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

Brief Summary

This study is A Multicentric, Open label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial to Evaluate Efficacy and Safety 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 that will be conducted in four centres in India

Detailed Description

Not available

Recruitment & Eligibility

• 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:oFeveroCoughoProduction of sputumoLeukocytosisoRadiographic 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: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 duration	10 day

Secondary Outcome Measures

Name	Time	Method
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.	10 days

Trial Locations

Locations (4)

Clinic, Bhavnagar,Rajivoza59@Hotmail.com; 🇮🇳 Bhavnagar, GUJARAT, India

KEM Hospital, Mumbai, Pkirtic@Yahoo.in; 🇮🇳 Mumbai, MAHARASHTRA, India

NHL Medical College & Hospital,Ahmedabad, Rajpurvi@Yahoo.com; 🇮🇳 Ahmadabad, GUJARAT, India

RN Cooper Hospital, Vileparle West, Mumbai, nitinmr@yahoo.in; 🇮🇳 Mumbai, MAHARASHTRA, India

Clinic, Bhavnagar,Rajivoza59@Hotmail.com

🇮🇳Bhavnagar, GUJARAT, India

Dr. Rajiv R Oza

Principal investigator

Rajivoza59@Hotmail.com