Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections

This study has been completed.

Study NCT00646958 Information provided by Rib-X Pharmaceuticals, Inc.

First Received on March 26, 2008. Last Updated on June 25, 2009 History of Changes

Results First Received: March 24, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Infectious Skin Diseases Bacterial Skin Diseases Staphylococcal Skin Infections Streptococcal Infections Abscess
Interventions:	Drug: Radezolid Drug: Linezolid

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
This study targeted participants with uncomplicated skin and soft tissue infections (uSSSI) for which oral, outpatient treatment was appropriate. Eligible uSSSIs included simple abscesses, impetigo, folliculitis, furunculosis, carbuncles, and cellulitis (area <10 cm2).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
450 mg Radezolid by Mouth (PO) Once Daily (QD)	No text entered.
450 mg Radezolid PO Twice Daily (BID)	No text entered.
600 mg Linezolid PO BID	No text entered.

Participant Flow: Overall Study

	450 mg Radezolid by Mouth (PO) Once Daily (QD)	450 mg Radezolid PO Twice Daily (BID)	600 mg Linezolid PO BID
STARTED	51 ^[1]	50 ^[2]	49 ^[2]
COMPLETED	40	41	40
NOT COMPLETED	11	9	9
Lack of Efficacy	1	0	0
Adverse Event	4	0	0
Lost to Follow-up	1	5	7
Protocol Violation	1	1	0
Abnormal screening lab tests	1	1	0
Withdrawal by Subject	1	2	0
Did not receive study drug	2	0	2

[1]	Number (No.) Participants Randomized
[2]	No. Participants Randomized

Baseline Characteristics

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Reporting Groups

	Description
450 mg Radezolid by Mouth (PO) Once Daily (QD)	No text entered.
450 mg Radezolid PO Twice Daily (BID)	No text entered.
600 mg Linezolid PO BID	No text entered.

Baseline Measures

	450 mg Radezolid by Mouth (PO) Once Daily (QD)	450 mg Radezolid PO Twice Daily (BID)	600 mg Linezolid PO BID	Total
Number of Participants [units: participants]	51	50	49	150
Age [units: years] Mean ± Standard Deviation	42.8 ± 12.43	43.6 ± 13.65	43.7 ± 16.33	43.3 ± 14.10
Gender [units: participants]
Female	14	14	13	41
Male	37	36	36	109

Outcome Measures

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1. Primary:

Number of Participants With a Clinical Response of Cure [ Time Frame: Test of Cure (TOC), day 10-20 ]

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2. Secondary:

Number of Patients With Per-Patient Microbiologic Response of Eradicated [ Time Frame: Test of Cure (TOC), day 10-20 ]

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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 sponsor retains control of all publication rights.

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
This was an unblinded study, which raises the possibility of bias.

Results Point of Contact:

Name/Title: Eric Burak, Ph.D.
Organization: Rib-X Pharmaceuticals, Inc.
phone: (203)-848-6923
e-mail: eburak@rib-x.com

No publications provided

Responsible Party:	Scott Hopkins, MD, Rib-X Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00646958 History of Changes
Other Study ID Numbers:	RX-1741-202
Study First Received:	March 26, 2008
Results First Received:	March 24, 2009
Last Updated:	June 25, 2009
Health Authority:	United States: Food and Drug Administration