A clinical trial to study the effects of two drugs, Faropenem extended release tablets and Faropenem conventional tablets in patients with respiratory tract infections (RTI)

Phase 3

Completed

• Conditions: Acute upper respiratory infection,unspecified, (2) ICD-10 Condition: J189||Pneumonia, unspecified organism, Respiratory tract infections (RTI), (3) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,

• Registration Number: CTRI/2009/091/000640
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

This study is an open label, comparative, multicentric study comparing the safety and efficacy of Faropenem sodium 300 mg extended-release tablets and Faropenem sodium 200 mg conventional tablets for a maximum of 14 days depending upon the site and severity of the infection in 200 patients with respiratory tract infections (RTI) that will be conducted in five centers in India. The primary outcome measures will be the clinical success rate in each of the infections as judged by either complete cure at the end of the treatment phase or significant improvement with no need for further antibiotic therapy at the end of the treatment phase.

The date of first enrollment in the trial was 13/06/2009.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-13
• Last Update Posted: 2018-11-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 1.Patients between 18-65 years of age.
• 2.Patients with established infection of the upper or lower respiratory tract (e.g. acute bacterial exacerbation of chronic bronchitis, acute sinusitis and/or community acquired pneumonia) 3.Informed consent of the patient/relative.

Exclusion Criteria

1.Pregnancy/Lactation/Less than 18 years of age.2.Grossly abnormal liver or kidney function tests or significant hematological abnormalities.3.History of known hypersensitivity to any of the penems, penicillincs, cephalosporins or other beta-lactams.4.Patients with CNS disorders or epilepsy or history of other factors that can predispose to seizures.5.Patients with serious infections requiring hospitalization or life-threatening in nature where monotherapy with Faropenem sodium would be considered inadequate.6.Patients receiving any other antibiotic/antibacterial agent in the previous 2/3 days prior to enrolment in the study.7.Patients with any other serious concurrent illness or malignancy.8.Patients with continuing history of alcohol and / or drug abuse.9.Participation in another clinical trial in the past 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The clinical success rate in each of the infections as judged by either complete cure at the end of the treatment phase or significant improvement with no need for further antibiotic therapy at the end of the treatment phase.	7 days & 14 days

Secondary Outcome Measures

Name	Time	Method
1)The bacterial eradication rates observed in these patients at the end of therapy	2)Overall assessment of efficacy given to the study medication by the investigator at the end of the study

Trial Locations

Locations (5)

ASHRAI ASSOCIATES, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

Chest & TB Hospital, Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

Department of Medicine, Government Medical College, Vadodara; 🇮🇳 Vadodara, GUJARAT, India

Mahatma Gandhi National Institute of Medical Sciences, Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

Shashwat Hospital & Research Centre, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

ASHRAI ASSOCIATES, Ahmedabad

🇮🇳Ahmadabad, GUJARAT, India

Dr. Tushar B. Patel

Principal investigator

079-26579550

drtusharpatel@yahoo.com