A clinical trial to assess efficacy and safety of a fixed dose combination of meropenam and sulbactam in lower respiratory tract infection caused by Gm (-ve) organisms including Pseudomonas aeruginosa.

A multicentric, open label, noncomparetive clinical trial to assess efficacy and safety of a fixed dose combination of meropenam and sulbactam in lower respiratory tract infection caused by Gm (-ve) organisms including Pseudomonas aeruginosa.

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2010/091/000569

Enrollment

200

Registered

2010-07-06

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- Lower respiratory tract infections caused by Gm (-ve) organisms including Pseudomonas aeruginosa with culture showing the organisms

Interventions

Intervention1: FDC of Meropenam 1000mg+ Sulbactam 500 mg: 7 to 10 days Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female subjects in the age group of 18-60 years have been selected. 2. Clinically diagnosed subjects lower respiratory infection with Gram (-)ve. 3. Subjects willing to give informed consent. 4. Patient must not have received any antibiotics in previous 4 week.

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity reaction or any specific contraindication to ofloxacin or ornidazole or Quinolone group or nitoimidazole group. 2. Presence of hepatic or renal disorders, 3. Pregnancy or lactation, 4. History of hearing loss, 5. Alcoholics 6. Previous history seizure or taking anti epileptic drugs.

Design outcomes

Secondary

Measure	Time frame
Time for complete resolution defined as (1)Complete resolution of all symptoms of respiratory infection, (2)The number of days after beginning treatment with FDC to discharge. Timepoint: 7th day and 10th day	—

Primary

Measure	Time frame
Clinical improvement & bacteriological conversion (when applicable) are the primary end-points and are defined as a subject who is (1)Afebrile for 48 hours, (2)Improvement of X-ray lesion as compared to pre-treatment, (3)sensitivity tests show absence of infecting organisms detected on initial culture on completion of 7 days of treatment and again 7 days after discontinuation of injectable antibacterial treatment particularly those cases where bacterial positivity persist in 7 days report. Timepoint: 3rd day, 7th day and 10th day	—

Measure

Time frame

Clinical improvement & bacteriological conversion (when applicable) are the primary end-points and are defined as a subject who is (1)Afebrile for 48 hours, (2)Improvement of X-ray lesion as compared to pre-treatment, (3)sensitivity tests show absence of infecting organisms detected on initial culture on completion of 7 days of treatment and again 7 days after discontinuation of injectable antibacterial treatment particularly those cases where bacterial positivity persist in 7 days report. Timepoint: 3rd day, 7th day and 10th day

—

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