CompletedNCT00379951Updated Feb 17, 2017

A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-048)

A Phase 3 interventional study of ertapenem sodium in Urinary Tract Infection, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-17.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 107
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Urinary Tract Infection

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Urinary Tract Infections 779

In context

Urinary Tract Infections

779 studies on the registry are indexed under Urinary Tract Infections; 132 are open to participants now.

This study's enrollment of 107 is below the median of 130 across 544 interventional studies indexed under Urinary Tract Infections.

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Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,160 studies on the registry; 134 are open to participants now.

Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 107 participants (actual)

Study arms

Experimental
1
Arm 1: ertapenem sodium
Drug: ertapenem sodium

Interventions

Drugertapenem sodium
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

What researchers measure

Primary outcomes

Safety and tolerability
Time frame: 14 Days

Secondary outcomes

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

Study locations

No study locations are listed for this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2005, a primary completion of May 2006 and a completion of May 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 22, 2006
First posted: Sep 25, 2006
Start: Jun 2005
Primary completionActual: May 2006
CompletionActual: May 2006
Last update: Feb 17, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00379951
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Sep 25, 2006
Start date: Jun 2005
Primary completion: May 2006
Completion: May 2006
Last update: Feb 17, 2017

Study contacts

Medical Monitor

study director · Merck Sharp & Dohme LLC

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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