Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections

This study has been completed.

Study NCT00430937 Information provided by Novartis

First Received on February 1, 2007. Last Updated on February 25, 2011 History of Changes

Results First Received: December 7, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Skin Diseases, Infectious Soft Tissue Infections
Interventions:	Drug: Daptomycin Drug: Vancomycin Drug: Teicoplanin

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	Daptomycin 4 mg/kg intravenous (i.v.) once daily
Pooled Comparator	Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.

Participant Flow: Overall Study

	Daptomycin	Pooled Comparator
STARTED	97	92
COMPLETED	70	64
NOT COMPLETED	27	28
Adverse Event	3	8
Death	0	1
Lost to Follow-up	6	6
Withdrawal by Subject	5	2
Protocol Violation	3	2
Lack of Efficacy	6	5
Inappropriate enrollment	2	1
Administrative reasons	1	0
Protocol discontinuation criteria met	1	2
Unable to classify	0	1

Baseline Characteristics

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Reporting Groups

	Description
Daptomycin	Daptomycin 4 mg/kg intravenous (i.v.) once daily
Pooled Comparator	Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.

Baseline Measures

	Daptomycin	Pooled Comparator	Total
Number of Participants [units: participants]	97	92	189
Age, Customized [units: Participants]
< 65 years	62	61	123
>=65 years	35	31	66
Gender [units: participants]
Female	36	41	77
Male	61	51	112

Outcome Measures

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1. Primary:

Clinical Success as Measured by Comparing the Participants Signs and Symptoms at the "Test of Cure" (TOC) Visit to Those Recorded at Study Baseline in the Clinically Evaluable Population. [ Time Frame: Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks ]

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2. Secondary:

Microbiological Efficacy Measured by the Number of Participants Achieving Bacteriological Eradication of Gram-positive Baseline Pathogens at the TOC Visit. [ Time Frame: Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks ]

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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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the 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
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00430937 History of Changes
Other Study ID Numbers:	CCBC134A2402
Study First Received:	February 1, 2007
Results First Received:	December 7, 2010
Last Updated:	February 25, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products France: French Health Products Safety Agency