Clinical Trial to Study the Safety and Effectiveness of MK0826 and Other Antibiotic Therapy in Patients With Complicated Urinary Tract Infection

This study has been terminated.

( feasibility and low enrollment )

Study NCT00771316 Information provided by Merck

First Received on October 9, 2008. Last Updated on June 14, 2010 History of Changes

Results First Received: April 22, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Urinary Tract Infections
Interventions:	Drug: MK0826 (ertapenem) Drug: Comparator: meropenem

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Phase III First patient enrolled on 09-Dec-2008 Last patient enrolled on 12-May-2009 The last patient's last visit was 08-Jun-2009 The study was conducted at 6 study centers in the United States and Europe. Study was terminated early due to feasibility issues including slow enrollment.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
MK0826 (Ertapenem)	MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
Meropenem	Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.

Participant Flow: Overall Study

	MK0826 (Ertapenem)	Meropenem
STARTED	4	2
COMPLETED	2	1
NOT COMPLETED	2	1
Adverse Event	0	1
Patient withdrew consent	1	0
Discontinued due to early termination	1	0

Baseline Characteristics

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Reporting Groups

	Description
MK0826 (Ertapenem)	MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
Meropenem	Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.

Baseline Measures

	MK0826 (Ertapenem)	Meropenem	Total
Number of Participants [units: participants]	4	2	6
Age [units: years] Mean ( Full Range )	37.75 ( 21 to 50 )	58 ( 58 to 58 )	44.5 ( 21 to 58 )
Gender [units: participants]
Female	2	0	2
Male	2	2	4
Race/Ethnicity, Customized [units: participants]
White	4	2	6

Outcome Measures

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1. Primary:

Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at the 5 to 9 Day Post Therapy Early Follow-up Visit [ Time Frame: 5 to 9 days post therapy ]

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2. Primary:

Number of Participants With Serious Urinary Tract Infection With a Clinical Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV) [ Time Frame: After at least 4 days of IV therapy ]

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3. Primary:

Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV) [ Time Frame: After at least 4 days of IV therapy ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The reason for early termination: Study was terminated early due to feasibility issues including slow enrollment.

Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00771316 History of Changes
Other Study ID Numbers:	2008_562, MK0826-054
Study First Received:	October 9, 2008
Results First Received:	April 22, 2010
Last Updated:	June 14, 2010
Health Authority:	United States: Food and Drug Administration