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Completed

NCT Number: NCT00318552

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

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Baja, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Meropenem

Drug

Primary outcomes

  1. Number of days from randomization to recovery from sepsis among those patients who survived the trial period

  2. Endpoint considered in conjunction with observed mortality rates to determine whether any reduction in time to recovery from sepsis

Secondary outcomes

  1. Number of days from randomization to ready to discharge from the ICU

  2. Number of days from randomization until patient is discharged from the ICU

  3. Number of days on first line antibiotic therapy

  4. Number of days from randomization until patient is discharged from hospital

  5. Proportion of patients who achieve clinical cure from sepsis following first line antibiotic therapy

  6. Proportion of all patients who are ready to discharge from the ICU following antibiotic therapy

  7. Mortality rate due to "all causes" in the meropenem group and the standard antibiotic therapy group

  8. Mortality rate due to infection in the meropenem group and the standard antibiotic therapy group

  9. Health Economics-Resource utilization for main treatment and diagnostic procedures, tools and materials

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Apr 27, 2006
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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