To Evaluate the Treatment Effect of an Anti-Infective Agent for Complicated Infections (0826-053)
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ClinicalTrials.gov Identifier: NCT00397956 |
Recruitment Status :
Completed
First Posted : November 10, 2006
Last Update Posted : October 30, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sepsis | Drug: MK0826, ertapenem sodium / Duration of Treatment: 14 Days | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | December 2005 |
Actual Study Completion Date : | December 2005 |
- Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment
- Safety and Tolerability

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00397956
Study Director: | Medical Monitor | Merck Sharp & Dohme LLC |
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT00397956 |
Other Study ID Numbers: |
0826-053 2006_047 |
First Posted: | November 10, 2006 Key Record Dates |
Last Update Posted: | October 30, 2015 |
Last Verified: | October 2015 |
Sepsis Infections Systemic Inflammatory Response Syndrome Inflammation |
Pathologic Processes Ertapenem Anti-Bacterial Agents Anti-Infective Agents |