Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00646958
First received: March 26, 2008
Last updated: February 26, 2014
Last verified: February 2014
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
Radezolid QD 450 mg by mouth (PO) once daily (QD)
Radezolid BID 450 mg by mouth (PO) twice daily (BID)
Linezolid BID 600 mg by mouth (PO) BID

Participant Flow:   Overall Study
    Radezolid QD     Radezolid BID     Linezolid 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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included those patients who were randomized and took at least one (1) dose of study medication.

Reporting Groups
  Description
Radezolid QD 450 mg by mouth (PO) once daily (QD)
Radezolid BID 450 mg by mouth (PO) twice daily (BID)
Linezolid BID 600 mg by mouth (PO) BID
Total Total of all reporting groups

Baseline Measures
    Radezolid QD     Radezolid BID     Linezolid 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 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: Eugene Sun, M.D.
Organization: Melinta Therapeutics
phone: 203.624.5606
e-mail: esun@melinta.com


No publications provided


Responsible Party: Melinta Therapeutics, 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: February 26, 2014
Health Authority: United States: Food and Drug Administration