Efficacy and safety of the fixed dose combination of cefepime and sulbactam

Multicentric, open labelled, non-randomised, clinical trial to assess efficacy and safety of the fixed dose combination of cefepime and sulbactam in complicated upper and lower tract infections

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN84455313

Enrollment

102

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

Complicated upper and lower tract infections Infections and Infestations Upper and lower tract infections

Interventions

Fixed dose combination of cefepime and sulbactam (1.5 g to 3 g, intravenous [i.v.] twice daily). Duration of treatment 7 to 10 days, followed for 7 days after the treatment.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants aged greater than 18 years (n = 102), either sex 2. Suffering from lower respiratory tract infections caused by gram negative organisms including pseudomonas aeruginosa

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity reaction or any specific contraindication to beta lactams 2. Presence of hepatic or renal disorders 3. Pregnancy or lactation 4. History of hearing loss 5. Alcoholics 6. Previous history seizure

Design outcomes

Primary

Measure	Time frame
Improvement in clinical and laboratory parameters, measured on day 0, day 3 and day 7 (completion of treatment).	—

Secondary

Measure	Time frame
To observe incidence of adverse events as assessed by clinical evaluation and laboratory parameters, measured on day 0, day 3 and day 7 (completion of treatment).	—

Countries

India

Outcome results

None listed

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