A clinical trial to compare the efficacy and safety of fixed dose combination of cefoperazone and tazobactam with cefoperazone alone in infections caused by Gm(-ve) organisms.

A multicentre,single blind, comparative clinical trial to compare the efficacy and safety of FDC of cefoperazone and tazobactam and cefoperazone alone in infections caused by Gm(-ve) organisms.

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2010/091/000484

Enrollment

200

Registered

2010-06-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Gm (-ve) infections with culture showing the organisms.

Interventions

Intervention1: FDC of Cefoperazone 1000mg/500mg+ Tazobactum125mg/62.5mg: 7 to 14 days Control Intervention1: Cefoperazone 1000mg/500mg: 7 to 14 days

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female subjects in the aged group of 18-60 years shall be selected. 2. Clinically diagonised subjects with gm (-ve) infections with culture showing the organisms. 3. Subjects willing to give informed consent. 4. Patient must not have received any antibiotics in previous 4 weeks.

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity reaction or any specific groups. 2. Presence of severe hepatic or renal disorders. 3. Pregnancy or lactation. 4. History of hearing loss. 5. Previous history seizure. 6. Alcoholic.

Design outcomes

Primary

Measure	Time frame
Clinical improvement and bacteriological conversion(when applicable) are the primary outcome and are defined as a subject who is - afebrile for 48 hours. - Improvement of X-ray lesion in lower respiratory tract infection as compared to pretreatment. - Isolation tests show the reduction or absence of infecting organisms detected in initial cultures on 48 hours, 7 days, 14 days of treatment and again 7 days after discontinuation of injectable antibacterial treatment. Timepoint:	—

Measure

Time frame

Clinical improvement and bacteriological conversion(when applicable) are the primary outcome and are defined as a subject who is - afebrile for 48 hours. - Improvement of X-ray lesion in lower respiratory tract infection as compared to pretreatment. - Isolation tests show the reduction or absence of infecting organisms detected in initial cultures on 48 hours, 7 days, 14 days of treatment and again 7 days after discontinuation of injectable antibacterial treatment. Timepoint:

—

Secondary

Measure	Time frame
The time for complete resolution defined as - complete resolution of all symptoms of infection. - The number of days after beginning treatment with FDC of cefoperazone & tazobactam or cefoperazone alone to discharge. Timepoint:	—

Countries

India

Contacts

Public ContactProf.(Dr.) Tapan Kumar Pal

tkpal12@gmail.com(033) 24146967. Mob: 09830036297

Outcome results

None listed

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