To Evaluate the Treatment Effect of an Anti-Infective Agent for Complicated Infections (0826-053)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-12-31

Brief Summary

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To collect clinical response data with the use of ertapenem in community acquired sepsis.

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Sepsis

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Detailed Description

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Conditions

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Sepsis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MK0826, ertapenem sodium / Duration of Treatment: 14 Days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female patients, 18 years of age or older
* Patients present with at least two of the following signs and symptom:
* fever (temperature\> 38c or \< 36c)
* heart rate \> 90 beats/min)
* respiratory rate\> 20 breaths/min)
* high white blood cell count \> 12,000/ul or \>10% bands)

Exclusion Criteria

* Patient has a history of allergy or hypersensitivity (anaphylaxis) or serious adverse reaction to ertapenem or any carbapenem
* Patient has a poor chance of survival for more than 14 days.
* Patient has an apache ii score \> 15 (see attachment 3.
* Patient has an infection caused by pathogens resistant to ertapenem
* The patient requires antibiotics other than ertapenem (such as: glycopeptides, macrolides or antifungal agents)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No