Ceftazidime tobramycin fixed drug combination (FDC) versus ceftazidime in lower respiratory tract infections

Comparative efficacy and synergy establishment of ceftazidime tobramycin fixed drug combination (FDC) versus ceftazidime in lower respiratory tract infections

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN69844323

Enrollment

240

Registered

2008-05-15

Start date

2007-05-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Lower respiratory tract infections Infections and Infestations Lower respiratory tract infections

Interventions

1. Ceftazidime (1 g) and tobramycin (120 mg) fixed drug combination (FDC), eight-hourly, intravenous (i.v.) for seven days 2. Ceftazidime (1 g), eight-hourly, i.v. for seven days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants aged greater than 18 years (n = 240), either sex 2. Hopsitalised patients suffering from lower respiratory tract infections

Exclusion criteria

Exclusion criteria: 1. Patients having received antibiotic treatment within two weeks of therapy 2. History of hypersensitivity reaction or any specific contraindication to beta lactams 3. Presence of hepatic or renal disorders 4. Pregnancy or lactation 5. History of hearing loss 6. Alcoholics 7. Previous history seizure

Design outcomes

Primary

Measure	Time frame
Improvement in clinical and laboratory parameters, measured on day 0 and day 7, followed up to 10 days after the treatment.	—

Secondary

Measure	Time frame
To observe incidence of adverse events as assessed by clinical evaluation and laboratory parameters, measured on day 0 and day 7, followed up to 10 days after the treatment.	—

Countries

India

Outcome results

None listed

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