A clinical trial to study the effects of two drugs, cefopodoxime and dicloxacillin in patients with various bacterial respiratory tract infections.

Phase 3

• Conditions: bacterial respiratory tract infections

• Registration Number: CTRI/2010/091/000589
• Lead Sponsor: Ms Theon Pharmaceuticals Ltd

Brief Summary

This study is a randomized, open label, parallel group, multicentre trial comparing the safety and efficacy of Cefopodoxime 200mg and Dicloxacillin 500mg in 200 patients with respiratory infections will be conducted in eight centres in India

Detailed Description

Not available

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Male and female subjects in the age of 18-70 years shall be selected.
• Subjects suffering from respiratory tract infections. -Subjects with normal RFT &LFT.
• Subjects willing to give informed consent.

Exclusion Criteria

Patients with significant primary insufficency including both intrinsic lung disease and respiratory failure.- Patients with pulmonary tuberculosis.- Patients with a history of known hypersensitivity from any one of the said medication.- Patients with acute myocardial infaraction, hypotension.- patients with uncontrolled hypertension._ subjects with severe hepatic, renal failure or encephalopathy.- Chronic alcoholics.- Patients with histiry of cardiac surgery.-Pregnant & lactating women.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in clinical and bacteriological/radiological parameters of the FDC of Cefopodoxime and Dicloxacillin in subjects with above mentioned infections.	5 and 10 days

Secondary Outcome Measures

Name	Time	Method
To see the safety and tolerability of FDC by observing the incidence of adverse events as assessed by clinical evaluation and laboratory parameters	5 to 10 days

Trial Locations

Locations (8)

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

Dr. R N Cooper Hospital,Mumbai, nitinmr@yahoo.in; 🇮🇳 Mumbai, MAHARASHTRA, India

Dr. Sudhakar Vyavahare?s Clinic, Nashik, sudhakar.vyavahare@yahoo.com; 🇮🇳 Nashik, MAHARASHTRA, India

Gillurkar Multispeciality Hospital Pvt. Ltd.,Nagpur, drkirtilata@yahoo.com; 🇮🇳 Nagpur, MAHARASHTRA, India

K E M Hospital, Mumbai, pkirtic@yahoo.in; 🇮🇳 Mumbai, MAHARASHTRA, India

Kusum Medical Nursing Home,Rajkot, drvijaykusum@yahoo.co.in; 🇮🇳 Rajkot, GUJARAT, India

N H L Medical college & Hospital, Ahmedabad, Rajpurvi@yahoo.com; 🇮🇳 Ahmadabad, GUJARAT, India

Pai Clinic Diagnostic Centre,Pune, pairahul73@gmail.com; 🇮🇳 Pune, MAHARASHTRA, India

Clinic, Bhavnagar, Rajivoza59@hotmail.com

🇮🇳Bhavnagar, GUJARAT, India

Dr. Rajiv R Oza

Principal investigator

Rajivoza59@hotmail.com