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

Completed

• Conditions: Complicated upper and lower tract infections; Infections and Infestations; Upper and lower tract infections

• Registration Number: ISRCTN84455313
• Lead Sponsor: Venus Remedies Limited (India)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-15
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 102

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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).