NCT00379951

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 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

June 1, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2006

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

September 22, 2006

Last Update Submit

February 16, 2017

Conditions

Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    14 Days

Secondary Outcomes (1)

  • Compare signs and symptoms of urinary tract infections at 14 days after treatment compared with signs and symptoms before treatment

    14 days after treatment

Study Arms (1)

1

EXPERIMENTAL

Arm 1: ertapenem sodium

Drug: ertapenem sodium

Interventions

ertapenem sodiumDRUG

ertapenem sodium as a single dose of 1gm I.V. was infused over a 30 min interval for a minimum of 3 days to a maximum of 14 days.

Also known as: MK0826, Invanz
1

Eligibility Criteria

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

You may qualify if:

  • Patient has a complicated urinary tract infection
  • Patient has acute pyelonephritis with fever, flank pain, pus in the urine, and positive urine culture
  • Patient is indian and 18 years of age or greater.

You may not qualify if:

  • Patient had a kidney transplant
  • Patient had been given antibiotic therapy for condition
  • Patient had poor liver function
  • Patient has complete obstruction of urinary tract
  • Patient has history of serious allergy to antibiotics and multivitamins
  • Patient is pregnant
  • Patient not likely to respond to 10 to 14 days of antibiotic therapy
  • Patient not likely to survive 4 week study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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

September 22, 2006

First Posted

September 25, 2006

Study Start

June 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

February 17, 2017

Record last verified: 2017-02