A Clinical study To evaluate Efficacy and Safety of FDC of Meropenem 1 gm Plus Tazobactam 125mg/250mg injection For the Treatment of Patients with Gram Negative Infection Including Pseudomonas aeruginosa

Phase 3

Completed

• Conditions: Escherichia coli [E. coli ] as thecause of diseases classified elsewhere,

• Registration Number: CTRI/2013/02/003401
• Lead Sponsor: Aqua Vitoe Laboratories

Brief Summary

This will be a multicentric, open-label, randomised, phase III clinical trial involving patients with gram negative infection including *Pseudomonas aeruginosa*receiving FDC meropenem 1 gm + tazobactam 125mg/250mg  injection (Investigationa product) or meropenem 1 gm injection (comparator product) three times in a day for 7-14 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-11
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 1.Written informed consent from the patient.
• 2.Male or Female patients aged greater than or equals to 18 years.
• 3.Patient’s culture defining presence of gram negative infection including Pseudomonas aeruginosa.
• 4.Patients who failed to prior antibacterial treatment can be enrolled but must have a positive culture test.
• 5.Willingness to comply with the study schedule and procedures.

Exclusion Criteria

• 1.Patients with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
• 2.Baseline pathogens known to be resistant to study agents at the study entry.
• 3.Concurrent confounding infection.
• 4.Patients who consume alcohol should not be enrolling into the study.
• 5.History of anaphylaxis or serious allergy to either study agent or antibiotic agents in the β-lactam class.
• 6.Patients having low likelihood of either treatment response or survival to follow-up visit.
• 7.Patients with ALT or AST more than six times the upper limit of normal (ULN).
• 8.Patients with neutropenia ( 1000 x million neutrophils/L).
• 9.A history of significant underlying disease or of hypersensitivity to either of the trial drugs.
• 10.Patient is a female who is pregnant or willing to get pregnant, no ready to use contraceptive measures during the trial period of breast feeding.
• 11.Hypovolaemia or dehydration from any cause.
• 12.Participation in any other clinical trial during last 30 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Clinical Response	7-14 days

Secondary Outcome Measures

Name	Time	Method
Changes in culture test for gram negative infection including Pseudomonas aeruginosa, Average Treatment Duration	7-14 days

Trial Locations

Locations (8)

Ahmedabad Institute of Medical Services (AIMS); 🇮🇳 Ahmadabad, GUJARAT, India

CHC Government Hospital; 🇮🇳 Ghazipur, UTTAR PRADESH, India

Dr. Shukla’s Hospital; 🇮🇳 Surat, GUJARAT, India

Kanoria Hospital and Research Centre; 🇮🇳 Gandhinagar, GUJARAT, India

MVJ Medical College & Research Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Nizam’s Institute of Medical Sciences; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Rajaji puram Hospital and Maternity Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

Sapthagiri Institute of Medical Science & Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

Ahmedabad Institute of Medical Services (AIMS)

🇮🇳Ahmadabad, GUJARAT, India

Dr Akhil Mukim

Principal investigator

07932523252

drmukim@indiatimes.com