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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00397956

First received: November 9, 2006

Last updated: November 28, 2014

Last verified: November 2014

History of Changes

Purpose

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

Condition	Intervention	Phase
Sepsis	Drug: MK0826, ertapenem sodium / Duration of Treatment: 14 Days	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Single-Arm, Non-Comparative Study to Evaluate the Efficacy, Tolerability & Convenience of Invanz(TM) (Ertapenem Sodium) In the Treatment of Community-Acquired Sepsis in Adults

Resource links provided by NLM:

MedlinePlus related topics: Sepsis

Drug Information available for: Ertapenem sodium Ertapenem

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment

Secondary Outcome Measures:

Safety and Tolerability


Estimated Enrollment:	30
Study Start Date:	September 2004
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397956

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

No publications provided


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00397956 History of Changes
Other Study ID Numbers:	0826-053, 2006_047
Study First Received:	November 9, 2006
Last Updated:	November 28, 2014
Health Authority:	Taiwan: National Bureau of Controlled Drugs

Additional relevant MeSH terms:


Ertapenem Anti-Bacterial Agents Anti-Infective Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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