Phase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus Infective Endocarditis (SAIE)

This study has been terminated.

(commitment completed)

Sponsor:

Information provided by (Responsible Party):

Cubist Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00638157

First received: March 12, 2008

Last updated: April 15, 2013

Last verified: April 2013

History of Changes

Results First Received: March 4, 2013

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:	Infective Endocarditis
Interventions:	Drug: daptomycin Drug: daptomycin and gentamicin

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
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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
Daptomycin	Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a
Daptomycin Plus Gentamicin	Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.

Participant Flow: Overall Study

	Daptomycin	Daptomycin Plus Gentamicin
STARTED	12	12
Treated	10	12
COMPLETED	5 ^[1]	8 ^[1]
NOT COMPLETED	7	4
Adverse Event	0	1
Clinical (symptomatic) failure	1	1
Microbiological failure	1	0
Lost to Follow-up	1	0
Physician Decision	1	0
Not Specified	1	2
Randomized, not treated	2	0

[1]	4 subjects completed study drug in this arm

Baseline Characteristics

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Reporting Groups

	Description
Daptomycin	Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a "dummy" infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy.
Daptomycin Plus Gentamicin	Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
Total	Total of all reporting groups

Baseline Measures

	Daptomycin	Daptomycin Plus Gentamicin	Total
Number of Participants [units: participants]	12	12	24
Age [units: years] Mean ± Standard Deviation	38.9 ± 10.93	45.3 ± 9.90	42.1 ± 10.71
Gender [units: participants]
Female	3	5	8
Male	9	7	16

Outcome Measures

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1. Primary:

Summary of Clinically Significant Increases in Serum Creatinine by Visit [ Time Frame: Baseline, EOT Visit, TOC ]

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2. Secondary:

Summary of the Investigator's Assessment of Clinical Response at the TOC Visit [ Time Frame: TOC Visit ]

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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: The first publication is initiated by Cubist. If First Publication not published within 1 year of Study conclusion or termination, Investigator has right to publish and disclose the Data. Prior to any submission for publication, presentation, or communication of results or information arising from the Study, Investigator shall provide Cubist at least 90 days for review and comment upon the manuscript or other material for such publication or presentation.

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
As the study was terminated prematurely, conclusions that can be drawn from the efficacy results are limited.

Results Point of Contact:

Name/Title: Ed Campanaro / Vice President, Clinical Operations
Organization: Cubist Pharmaceuticals
phone: 781-860-8318
e-mail: ed.campanaro@cubist.com

No publications provided

Responsible Party:	Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00638157 History of Changes
Other Study ID Numbers:	DAP-4IE-06-03
Study First Received:	March 12, 2008
Results First Received:	March 4, 2013
Last Updated:	April 15, 2013
Health Authority:	United States: Food and Drug Administration

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