Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients.

Sepsis Clinical Trial

Official title:

Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients. An Open, Randomized Multi-center Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318552
• Other study ID #: 3591/9014
• Secondary ID: D9211C09014
• Status: Completed
• Phase: Phase 4
• First received: April 25, 2006
• Last updated: August 31, 2017
• Start date: January 2002
• Est. completion date: June 2006

Study information

• Verified date: August 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will directly compare meropenem with standard first line antibiotic therapies in subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while resident in an ICU.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female subjects aged = 18, requiring intensive care treatment related to secondary nosocomial sepsis, who require potent broad spectrum intravenous antibiotic therapy.

Exclusion Criteria:

Related Conditions & MeSH terms

• Sepsis
• Systemic Inflammatory Response Syndrome
• Toxemia

Intervention

Drug:
• Meropenem

Locations

Country	Name	City	State
Hungary	Research Site	Baja
Hungary	Research Site	Budapest
Hungary	Research Site	Eger
Hungary	Research Site	Kecskemet
Hungary	Research Site	Kistarcsa
Hungary	Research Site	Miskolc
Hungary	Research Site	Pecs
Hungary	Research Site	Siofok
Hungary	Research Site	Szekesfehervar
Hungary	Research Site	Szolnok
Hungary	Research Site	Szombathely
Hungary	Research Site	Veszprem

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days from randomization to recovery from sepsis among those patients who survived the trial period
Primary	Endpoint considered in conjunction with observed mortality rates to determine whether any reduction in time to recovery from sepsis
Secondary	Number of days from randomization to ready to discharge from the ICU
Secondary	Number of days from randomization until patient is discharged from the ICU
Secondary	Number of days on first line antibiotic therapy
Secondary	Number of days from randomization until patient is discharged from hospital
Secondary	Proportion of patients who achieve clinical cure from sepsis following first line antibiotic therapy
Secondary	Proportion of all patients who are ready to discharge from the ICU following antibiotic therapy
Secondary	Mortality rate due to "all causes" in the meropenem group and the standard antibiotic therapy group
Secondary	Mortality rate due to infection in the meropenem group and the standard antibiotic therapy group
Secondary	Health Economics-Resource utilization for main treatment and diagnostic procedures, tools and materials