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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
NameTimeMethod
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
NameTimeMethod
To see the safety and tolerability of FDC by observing the incidence of adverse events as assessed by clinical evaluation and laboratory parameters5 to 10 days

Trial Locations

Locations (8)

Clinic, Bhavnagar, Rajivoza59@hotmail.com

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Bhavnagar, GUJARAT, India

Dr. R N Cooper Hospital,Mumbai, nitinmr@yahoo.in

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Mumbai, MAHARASHTRA, India

Dr. Sudhakar Vyavahare?s Clinic, Nashik, sudhakar.vyavahare@yahoo.com

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Nashik, MAHARASHTRA, India

Gillurkar Multispeciality Hospital Pvt. Ltd.,Nagpur, drkirtilata@yahoo.com

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Nagpur, MAHARASHTRA, India

K E M Hospital, Mumbai, pkirtic@yahoo.in

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Mumbai, MAHARASHTRA, India

Kusum Medical Nursing Home,Rajkot, drvijaykusum@yahoo.co.in

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Rajkot, GUJARAT, India

N H L Medical college & Hospital, Ahmedabad, Rajpurvi@yahoo.com

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Ahmadabad, GUJARAT, India

Pai Clinic Diagnostic Centre,Pune, pairahul73@gmail.com

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Pune, MAHARASHTRA, India

Clinic, Bhavnagar, Rajivoza59@hotmail.com
🇮🇳Bhavnagar, GUJARAT, India
Dr. Rajiv R Oza
Principal investigator
Rajivoza59@hotmail.com

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