NCT00397956

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3 sepsis

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_3 sepsis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2006

Completed
Last Updated

October 30, 2015

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

November 9, 2006

Last Update Submit

October 29, 2015

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Safety and Tolerability

Interventions

MK0826, ertapenem sodium / Duration of Treatment: 14 DaysDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sepsis

Interventions

ErtapenemDuration of Therapy

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2006

First Posted

November 10, 2006

Study Start

September 1, 2004

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

October 30, 2015

Record last verified: 2015-10