Safety and efficacy of a fixed dose combination of cefepime and amikacin

An open labelled post marketing surveillance study to evaluate safety and efficacy of a fixed dose combination of cefepime and amikacin in subjects with mild to severe infections

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN61799591

Enrollment

315

Registered

2008-05-15

Start date

2007-04-28

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

Nosocomial pneumonia, febrile neutropenia, other bacterial infections Infections and Infestations Infections

Interventions

The subjects were divided in three groups as per the severity of the infection: 1. Group A (severely infected) were given 2.5 g twice daily (BD) of cefepime-amikacin fixed dose combination (FDC) 2. G

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Hospitalised patients of either sex 2. Above 18 years of age 3. Clinically diagnosed subjects with moderate to severe infections of: 3.1. Febrile neutropenia (n = 110) 3.2. Nosocomial pneumonia (n = 110) 3.3. Other bacterial infection (n = 91)

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity reaction or any specific contraindication to penicillin group of drugs 2. Hepatic or renal disorder or any heart disorder 3. Pregnancy and/or lactation 4. History of hearing loss 5. Alcoholics

Design outcomes

Primary

Measure	Time frame
Improvement in clinical and laboratory parameters, measured on day 0 and completion of treatment (COT) (i.e. day 5 - 7 or COT).	—

Secondary

Measure	Time frame
To observe incidence of adverse events as assessed by clinical evaluation and laboratory parameters, measured on day 0 and completion of treatment (COT) (i.e. day 5 - 7 or COT).	—

Countries

India

Outcome results

None listed

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