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| 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
| 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). |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
| 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. |
| 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
| 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. |
| 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 |
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Age
[units: years] Mean ± Standard Deviation |
42.8 ± 12.43 | 43.6 ± 13.65 | 43.7 ± 16.33 | 43.3 ± 14.10 |
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Gender
[units: participants] |
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| Female | 14 | 14 | 13 | 41 |
| Male | 37 | 36 | 36 | 109 |
Outcome Measures
More Information
| 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:
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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. |
| 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 |