Trial Outcomes & Findings for Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections (NCT NCT00646958)
NCT ID: NCT00646958
Last Updated: 2014-03-27
Results Overview
To qualify as a Cure, participants were required to fulfill the following criteria: all systemic signs and symptoms of uSSSI present at screening were improved or resolved; no further antibiotic therapy was necessary for treatment of uSSSI; and there was no worsening or appearance of new signs and symptoms of uSSSI.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
Test of Cure (TOC), day 10-20
Results posted on
2014-03-27
Participant Flow
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).
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
49
|
|
Overall Study
COMPLETED
|
40
|
41
|
40
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
9
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
4
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
7
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
|
Overall Study
Abnormal screening lab tests
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
|
Overall Study
Did not receive study drug
|
2
|
0
|
2
|
Baseline Characteristics
Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections
Baseline characteristics by cohort
| Measure |
Radezolid QD
n=51 Participants
450 mg by mouth (PO) once daily (QD)
|
Radezolid BID
n=50 Participants
450 mg by mouth (PO) twice daily (BID)
|
Linezolid BID
n=49 Participants
600 mg by mouth (PO) BID
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 12.43 • n=5 Participants
|
43.6 years
STANDARD_DEVIATION 13.65 • n=7 Participants
|
43.7 years
STANDARD_DEVIATION 16.33 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 14.10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Test of Cure (TOC), day 10-20Population: Clinically Evaluable participants were those that met the entry criteria, received a certain amount of drug, did not receive any additional antibiotics before Test of Cure (TOC), and who presented for a TOC evaluation in the appropriate window.
To qualify as a Cure, participants were required to fulfill the following criteria: all systemic signs and symptoms of uSSSI present at screening were improved or resolved; no further antibiotic therapy was necessary for treatment of uSSSI; and there was no worsening or appearance of new signs and symptoms of uSSSI.
Outcome measures
| Measure |
Radezolid QD
n=39 Participants
450 mg by mouth (PO) once daily (QD)
|
Radezolid BID
n=36 Participants
450 mg by mouth (PO) twice daily (BID)
|
Linezolid BID
n=38 Participants
600 mg by mouth (PO) BID
|
|---|---|---|---|
|
Number of Participants With a Clinical Response of Cure
|
38 Participants
|
34 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Test of Cure (TOC), day 10-20Population: Microbiologically Evaluable patients were those that met the entry criteria, received a certain amount of drug, did not receive any additional antibiotics before TOC, presented for a TOC evaluation in the appropriate window, and who had a baseline pathogen that was susceptible to study drug.
The microbiological response at the patient level was considered Eradicated (documented or presumed)if no pathogens were present in repeat cultures taken from the original site of infection or a clinical response of cure precluded the ability to obtain a culturable specimen.
Outcome measures
| Measure |
Radezolid QD
n=20 Participants
450 mg by mouth (PO) once daily (QD)
|
Radezolid BID
n=26 Participants
450 mg by mouth (PO) twice daily (BID)
|
Linezolid BID
n=23 Participants
600 mg by mouth (PO) BID
|
|---|---|---|---|
|
Number of Patients With Per-Patient Microbiologic Response of Eradicated
|
20 Participants
|
23 Participants
|
21 Participants
|
Adverse Events
Radezolid QD
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Radezolid BID
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Linezolid BID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Radezolid QD
n=49 participants at risk
450 mg by mouth (PO) once daily (QD)
|
Radezolid BID
n=50 participants at risk
450 mg by mouth (PO) twice daily (BID)
|
Linezolid BID
n=47 participants at risk
600 mg by mouth (PO) BID
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
22.4%
11/49 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
22.0%
11/50 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
2.1%
1/47 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
|
Nervous system disorders
Headache
|
12.2%
6/49 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
6.0%
3/50 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
6.4%
3/47 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
|
Gastrointestinal disorders
Nausea
|
8.2%
4/49 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
2.0%
1/50 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
6.4%
3/47 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
|
Investigations
Elevated AST
|
4.1%
2/49 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
0.00%
0/50 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
0.00%
0/47 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
|
Investigations
Abnormal LFT
|
0.00%
0/49 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
4.0%
2/50 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
2.1%
1/47 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/49 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
4.0%
2/50 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
0.00%
0/47 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
|
Infections and infestations
Infections and infestations
|
4.1%
2/49 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
0.00%
0/50 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
0.00%
0/47 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
|
Investigations
Investigations
|
6.1%
3/49 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
8.0%
4/50 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
8.5%
4/47 • Safety was monitored as follows: on Day 1 (after signing the informed consent), and on Days 5 (on therapy) +/-1; 5-10 (EOT) +/-1; and 10-20 (TOC) +/-1. All SAEs and any AEs ongoing at TOC were followed until they either resolved or were deemed stable.
While 51, 50 and 49 subjects were randomized to radezolid qd, radezolid bid, and linezolid, respectively, safety was assessed in the ITT population (those who received at least 1 dose of study drug.) Four subjects (2 in radezolid qd and 2 in linezolid) did not receive any study drug; thus, the # of subjects at risk is 49, 50 and 47, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor retains control of all publication rights.
- Publication restrictions are in place
Restriction type: OTHER