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

A Phase III, Multicenter, Randomized, Open Label, Clinical study To evaluate Efficacy and Safety of two strengths of Meropenem Plus Tazobactam For the Treatment of Patients with Gram Negative Infection Including Pseudomonas aeruginosa

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/02/003401

Enrollment

300

Registered

2013-02-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B962- Escherichia coli [E. coli ] as thecause of diseases classified elsewhere

Interventions

Intervention1: Meropenem 1 gm + Tazobactam 125 mg Injection: twice daily for 7-14 days by intravenous route Intervention2: Meropenem 1 gm + Tazobactam 250 mg Injection: twice daily for 7-14 days by in

Eligibility

Inclusion criteria

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

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 ß-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.

Design outcomes

Primary

Measure	Time frame
Overall Clinical ResponseTimepoint: 7-14 days	—

Secondary

Measure	Time frame
Changes in culture test for gram negative infection including Pseudomonas aeruginosa, Average Treatment DurationTimepoint: 7-14 days	—

Countries

India

Contacts

Public ContactMr Shyam Garg

Ethicare Clinical Trial Services

milansatia@ethicare-cro.com09825585119

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026