Garenoxacin Tablets in patients with Community acquired pneumonia

Phase 3

Recruiting

• Conditions: Communite Aquired Pneumonia

• Registration Number: CTRI/2011/10/002055
• Lead Sponsor: Hetero Labs Ltd

Brief Summary

This is a Comparative, Randomised, Open-label, Parallel, Multicentric study of efficacy and safety of oral Garenoxacin versus Levofloxacin in patients with Community Aquired Pneumonia.  2. The proposed number of subject to be enrolled in to the study is 250 (this number includes the expected no. of dropouts) and data will be submitted 200 completed patients. Study population will comprise of Patients with Community Aquired Pneumonia. 3. The recommended dose of Garenoxacin in dose of 2x200mg in comparison with Levofloxacin in dose of 500mg once daily  for 7/10 days. 4. The primary efficacy outcome will be clinically relevant reduction in signs and symptoms of Community Aquired Pneumonia from baseline to end treatment and the secondary efficacy outcome is to evaluate of the safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2011-07-09
• Study Start: 2011-07-21

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 1. Patient’s atleast 18 years of age with Community Acquired Pneumonia. (Acute bronchitis, acute exacerbation of chronic bronchitis, Community Acquired pneumonia). 2. Clinical signs and symptoms consistent with Community Acquired Pneumonia suspected of being caused by bacteria susceptible to Garenoxacin and where investigator deemed oral Garenoxacin to be appropriate therapy by clinical suspicion with or without positive culture results. 3. Clinical diagnosis.
• Patient should have atleast two of the following signs and symptoms: a. Cough b. Production of purulent sputum or change in character of sputum c. Auscultator findings of rales and / or evidence of consolidation (dullness of percussion, bronchial breath sounds or egophony) d. Fever defined as oral temperature 380C e. Dyspnoea or tacypnoea f. Total WBC count 10,000 /cumm 4. Radiological diagnosis.
• Chest radiograph showing the presence of a new alveolar or patchy infiltrates suggestive of acute pneumonia 5. Microbiological diagnosis.
• Gram stain examination of sputum specimen showing presence of micro-organisms, squamous epithelial cells and polymorph nuclear cells 6. Biochemistry, haematology, and urine analysis test results without clinically significant abnormalities. 7. Patients willing to give informed written consent.

Exclusion Criteria

• Pregnant and lactating women.
• Patients with clinically significant renal or hepatic disease.
• Patients who have shown immediate hypersensitivity reactions to the quinolone class of antibiotics.
• Patients with bronchialasthma,bronchiectasis, cystic fibrosis, and lung abscess, AIDS, Pneumocystis caranii pneumonia, pulmonary tuberculosis, primary or secondary lung malignancy.
• Patients with extensive bilateral consolidation and pleural effusion.
• Patients with severe neurological or cardiovascular disease and uncontrolled diabetes mellitus 7.
• History of having received any investigation drugs in previous one month or has donated blood in last 3 months.
• Patients with abnormal lab values (2 times of upper limit of normal).
• Non co-operative attitude of the patient.
• Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion for the study.
• Patients with any condition or concomitant infection, which in the opinion of the investigator could preclude evaluation of response to study medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy outcome will be clinically relevant reduction in signs and symptoms of Community Aquired Pneumonia from baseline to end treatment	0, 4, 7/10 days

Secondary Outcome Measures

Name	Time	Method
The Secondary outcome is to evaluate safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study	0, 4, 7/10 days

Trial Locations

Locations (18)

Amar Medical & Research Center; 🇮🇳 Jaipur, RAJASTHAN, India

Bopal Multispeciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Dhawal nursing home; 🇮🇳 Vadodara, GUJARAT, India

Dr. Vipin kumar Jain Clinic; 🇮🇳 Jaipur, RAJASTHAN, India

Gujarat Pulmonary & Critical care clinic; 🇮🇳 Ahmadabad, GUJARAT, India

Infectious Disease Care Clinic, Shubham super speciality Hospital,; 🇮🇳 Ahmadabad, GUJARAT, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

KRIMS Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Marudhar hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Metro Hospital & Research Institute; 🇮🇳 Vadodara, GUJARAT, India

Scroll for more (8 remaining)

Amar Medical & Research Center

🇮🇳Jaipur, RAJASTHAN, India

Dr Govind Saini

Principal investigator

govind.amrc@gmail.com