Trial Outcomes & Findings for MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection (NCT NCT02269319)
NCT ID: NCT02269319
Last Updated: 2024-11-04
Results Overview
* Did not receive a systemic antibacterial agent with activity against gram-positive organisms * Did not die of any cause up to EA
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
48-72 hours
Results posted on
2024-11-04
Participant Flow
Participant milestones
| Measure |
MRX-I
MRX-I tablets 800 mg given twice a day for 10 days
MRX-I: Oral MRX-I 800mg given twice a day for 10 days
|
Linezolid
Linezolid 600 mg given twice a day for 10 days
Linezolid: Oral linezolid 600mg given twice a day for 10 days
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
40
|
|
Overall Study
COMPLETED
|
75
|
36
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
MRX-I
MRX-I tablets 800 mg given twice a day for 10 days
MRX-I: Oral MRX-I 800mg given twice a day for 10 days
|
Linezolid
Linezolid 600 mg given twice a day for 10 days
Linezolid: Oral linezolid 600mg given twice a day for 10 days
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Instructions not followed
|
1
|
0
|
Baseline Characteristics
MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
Baseline characteristics by cohort
| Measure |
MRX-I
n=80 Participants
MRX-I tablets 800 mg given twice a day for 10 days
MRX-I: Oral MRX-I 800mg given twice a day for 10 days
|
Linezolid
n=40 Participants
Linezolid 600 mg given twice a day for 10 days
Linezolid: Oral linezolid 600mg given twice a day for 10 days
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.9 years
n=93 Participants
|
38.8 years
n=4 Participants
|
38.2 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
80 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 48-72 hoursPopulation: Intent-to-Treat (ITT)
* Did not receive a systemic antibacterial agent with activity against gram-positive organisms * Did not die of any cause up to EA
Outcome measures
| Measure |
MRX-I
n=80 Participants
MRX-I tablets 800 mg given twice a day for 10 days
MRX-I: Oral MRX-I 800mg given twice a day for 10 days
|
Linezolid
n=40 Participants
Linezolid 600 mg given twice a day for 10 days
Linezolid: Oral linezolid 600mg given twice a day for 10 days
|
|---|---|---|
|
Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline
|
72 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Day 10Population: Intent-to-Treat (ITT)
Outcome measures
| Measure |
MRX-I
n=80 Participants
MRX-I tablets 800 mg given twice a day for 10 days
MRX-I: Oral MRX-I 800mg given twice a day for 10 days
|
Linezolid
n=40 Participants
Linezolid 600 mg given twice a day for 10 days
Linezolid: Oral linezolid 600mg given twice a day for 10 days
|
|---|---|---|
|
Number of Patients at EOT With a 80% Reduction in ABSSSI Lesion Size Compared to Baseline
|
70 Participants
|
32 Participants
|
Adverse Events
MRX-I
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Linezolid
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MRX-I
n=80 participants at risk
MRX-I tablets 800 mg given twice a day for 10 days
MRX-I: Oral MRX-I 800mg given twice a day for 10 days
|
Linezolid
n=40 participants at risk
Linezolid 600 mg given twice a day for 10 days
Linezolid: Oral linezolid 600mg given twice a day for 10 days
|
|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
1.2%
1/80 • Number of events 1 • 39 days
|
0.00%
0/40 • 39 days
|
Other adverse events
| Measure |
MRX-I
n=80 participants at risk
MRX-I tablets 800 mg given twice a day for 10 days
MRX-I: Oral MRX-I 800mg given twice a day for 10 days
|
Linezolid
n=40 participants at risk
Linezolid 600 mg given twice a day for 10 days
Linezolid: Oral linezolid 600mg given twice a day for 10 days
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
15.0%
12/80 • 39 days
|
10.0%
4/40 • 39 days
|
|
Infections and infestations
Abscess
|
11.2%
9/80 • 39 days
|
7.5%
3/40 • 39 days
|
|
Gastrointestinal disorders
Vomiting
|
8.8%
7/80 • 39 days
|
7.5%
3/40 • 39 days
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
6.2%
5/80 • 39 days
|
2.5%
1/40 • 39 days
|
|
Infections and infestations
Urinary Tract Infection
|
6.2%
5/80 • 39 days
|
0.00%
0/40 • 39 days
|
|
Vascular disorders
Hypertension
|
3.8%
3/80 • 39 days
|
2.5%
1/40 • 39 days
|
|
Nervous system disorders
Headache
|
3.8%
3/80 • 39 days
|
0.00%
0/40 • 39 days
|
|
Infections and infestations
Upper Respiratory Tract Infections
|
3.8%
3/80 • 39 days
|
0.00%
0/40 • 39 days
|
Additional Information
John M. Sall, Global Head of Regulatory
MicuRx Pharmaceuticals Inc.
Phone: 919-670-7803
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place