- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00397956
To Evaluate the Treatment Effect of an Anti-Infective Agent for Complicated Infections (0826-053)
October 29, 2015 updated by: Merck Sharp & Dohme LLC
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
To collect clinical response data with the use of ertapenem in community acquired sepsis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
30
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment
|
Secondary Outcome Measures
Outcome Measure |
---|
Safety and Tolerability
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Primary Completion (Actual)
December 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
November 9, 2006
First Submitted That Met QC Criteria
November 9, 2006
First Posted (Estimate)
November 10, 2006
Study Record Updates
Last Update Posted (Estimate)
October 30, 2015
Last Update Submitted That Met QC Criteria
October 29, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0826-053
- 2006_047
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sepsis
-
University of Kansas Medical CenterUniversity of KansasRecruitingSepsis | Septic Shock | Sepsis Syndrome | Sepsis, Severe | Sepsis Bacterial | Sepsis BacteremiaUnited States
-
Jip GroenInBiomeRecruitingMicrobial Colonization | Neonatal Infection | Neonatal Sepsis, Early-Onset | Microbial Disease | Clinical Sepsis | Culture Negative Neonatal Sepsis | Neonatal Sepsis, Late-Onset | Culture Positive Neonatal SepsisNetherlands
-
The University of QueenslandRoyal Brisbane and Women's HospitalUnknown
-
Karolinska InstitutetÖrebro University, SwedenCompletedSepsis | Sepsis Syndrome | Sepsis, SevereSweden
-
Ohio State UniversityCompletedSepsis, Severe Sepsis and Septic ShockUnited States
-
Indonesia UniversityCompletedSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockIndonesia
-
University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsCompletedSepsis | Septic Shock | Severe Sepsis | Sepsis SyndromeUnited Kingdom
-
Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityRecruitingSevere Sepsis | Severe Sepsis Without Septic ShockUnited States
-
Weill Medical College of Cornell UniversityNational Heart, Lung, and Blood Institute (NHLBI); New York Presbyterian Hospital and other collaboratorsCompletedSepsis | Septic Shock | Severe Sepsis | Infection | Sepsis SyndromeUnited States
-
Inverness Medical InnovationsCompletedSepsis | Systemic Inflammatory Response Syndrome | Severe Sepsis | Sepsis SyndromeUnited States
Clinical Trials on MK0826, ertapenem sodium / Duration of Treatment: 14 Days
-
Merck Sharp & Dohme LLCCompletedUrinary Tract Infections | Soft Tissue Infections | Bacterial Pneumonia
-
Merck Sharp & Dohme LLCCompletedPneumonia | Urinary Tract Infection | Infection
-
Merck Sharp & Dohme LLCCompletedFoot Infections in Diabetic Patients
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompletedComplicated Intra-Abdominal Infections
-
IpsenCompleted
-
IpsenCompleted
-
Enanta Pharmaceuticals, IncUnknownCommunity Acquired PneumoniaUnited States
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompletedInfections | Pelvic Infections