NCT00398099

Brief Summary

To collect clinical response data with the use of ertapenem in approved indications.

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

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_3

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

July 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
10 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

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

November 9, 2006

Last Update Submit

February 16, 2017

Conditions

InfectionPneumoniaUrinary Tract Infection

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

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients, 20 years of age or older
  • Patients did not receive any systemic antibiotic before enrollment, or patients with failed clinical response (no improvement on symptoms or laboratory data) through previous antibiotic treatment
  • Patients who required therapy prior to identification of cause of infection

You may not qualify if:

  • Patient has a concomitant infection that may interfere with the evaluation of the response to ertapenem
  • Patient has an apache ii \> 30.
  • Patient has an infection caused by pathogens resistant to ertapenem
  • Patients with known allergy to ertapenem or other drugs in the same carbapenem class, beta - lactams, lidocaine or local anesthetics of the amide type
  • 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

InfectionsPneumoniaUrinary Tract Infections

Interventions

ErtapenemDuration of Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

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

July 1, 2005

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

February 17, 2017

Record last verified: 2017-02