A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-048)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00379951 |
Recruitment Status :
Completed
First Posted : September 25, 2006
Last Update Posted : February 17, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urinary Tract Infection | Drug: ertapenem sodium | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 107 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Multicenter, Noncomparative, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections |
Study Start Date : | June 2005 |
Actual Primary Completion Date : | May 2006 |
Actual Study Completion Date : | May 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Arm 1: ertapenem sodium
|
Drug: ertapenem 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.
Other Names:
|
- Safety and tolerability [ Time Frame: 14 Days ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379951
Study Director: | Medical Monitor | Merck Sharp & Dohme LLC |

Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT00379951 |
Other Study ID Numbers: |
0826-048 2006_036 |
First Posted: | September 25, 2006 Key Record Dates |
Last Update Posted: | February 17, 2017 |
Last Verified: | February 2017 |
Infections Communicable Diseases Urinary Tract Infections Disease Attributes Pathologic Processes |
Urologic Diseases Ertapenem Anti-Bacterial Agents Anti-Infective Agents |