Trial Outcomes & Findings for Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites (NCT NCT02436876)
NCT ID: NCT02436876
Last Updated: 2021-09-30
Results Overview
This study evaluates the safety and tolerability of single escalating doses of locally administered MBN-101 or placebo, as adjunct to standard of care antimicrobial and surgical therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-09-30
Participant Flow
Participants were recruited based on physician referral. The study was sponsored by Microbion Corporation and conducted at 6 hospital clinical sites in the United States. The study was initiated on May 24, 2016, the Primary Completion Date was October 27, 2017, and the Study Completion Date was July 26, 2018.
A total of 20 patients were treated and completed the study.
Participant milestones
| Measure |
MBN-101 0.5 µg/cm2
Single, intra-wound local administration of MBN-101; dosage = 0.5 µg/cm2; randomized 3:1 with placebo
MBN-101: MBN-101 is a locally administered, anti-infective drug product
|
MBN-101 1.5 µg/cm2
Single, intra-wound local administration of MBN-101; dosage = 1.5 µg/cm2; randomized 3:1 with placebo
MBN-101: MBN-101 is a locally administered, anti-infective drug product
|
MBN-101 5.0 µg/cm2
Single, intra-wound local administration of MBN-101; dosage = 5.0 µg/cm2; randomized 3:1 with placebo
MBN-101: MBN-101 is a locally administered, anti-infective drug product
|
Placebo
Placebo: The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient. Placebo subjects were randomized 1:3 with subjects treated with active.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
7
|
7
|
|
Overall Study
Treated
|
6
|
6
|
6
|
7
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
2
|
2
|
Reasons for withdrawal
| Measure |
MBN-101 0.5 µg/cm2
Single, intra-wound local administration of MBN-101; dosage = 0.5 µg/cm2; randomized 3:1 with placebo
MBN-101: MBN-101 is a locally administered, anti-infective drug product
|
MBN-101 1.5 µg/cm2
Single, intra-wound local administration of MBN-101; dosage = 1.5 µg/cm2; randomized 3:1 with placebo
MBN-101: MBN-101 is a locally administered, anti-infective drug product
|
MBN-101 5.0 µg/cm2
Single, intra-wound local administration of MBN-101; dosage = 5.0 µg/cm2; randomized 3:1 with placebo
MBN-101: MBN-101 is a locally administered, anti-infective drug product
|
Placebo
Placebo: The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient. Placebo subjects were randomized 1:3 with subjects treated with active.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
1
|
0
|
|
Overall Study
Inadequate amount of study drug available for randomization
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites
Baseline characteristics by cohort
| Measure |
MBN-101 0.5 µg/cm2
n=6 Participants
Single, intra-wound local administration of MBN-101; randomized 3:1 with placebo
MBN-101 is a locally administered, anti-infective drug product
|
MBN-101 1.5 µg/cm2
n=6 Participants
Single, intra-wound local administration of MBN-101; randomized 3:1 with placebo
MBN-101 is a locally administered, anti-infective drug product
|
MBN-101 5.0 µg/cm2
n=6 Participants
Single, intra-wound local administration of MBN-101; randomized 3:1 with placebo
MBN-101 is a locally administered, anti-infective drug product
|
Placebo
n=7 Participants
Placebo: The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient. Placebo subjects were randomized 1:3 with subjects treated with active.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
19 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThis study evaluates the safety and tolerability of single escalating doses of locally administered MBN-101 or placebo, as adjunct to standard of care antimicrobial and surgical therapy.
Outcome measures
| Measure |
MBN-101 0.5 µg/cm2
n=6 Participants
Single, intra-wound local administration of MBN-101; dosage = 0.5 µg/cm2; randomized 3:1 with placebo
|
MBN-101 1.5 µg/cm2
n=6 Participants
Single, intra-wound local administration of MBN-101; dosage = 1.5 µg/cm2; randomized 3:1 with placebo
|
MBN-101 5.0 µg/cm2
n=6 Participants
Single, intra-wound local administration of MBN-101; dosage = 5.0 µg/cm2; randomized 3:1 with placebo
|
Placebo
n=7 Participants
The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient. Placebo was randomized 1:3 with active drug product treatment Cohorts 1-3
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
Safety: SAEs
|
4 participants
|
2 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Adverse Events
Safety: Drug-related TEAEs
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Adverse Events
Safety: TEAEs
|
5 participants
|
4 participants
|
1 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 12 weeksTreatment failure is defined as clinical course requiring additional infection-related interventions including rehospitalization, additional surgery, or additional courses of systemic antibiotics.
Outcome measures
| Measure |
MBN-101 0.5 µg/cm2
n=6 Participants
Single, intra-wound local administration of MBN-101; dosage = 0.5 µg/cm2; randomized 3:1 with placebo
|
MBN-101 1.5 µg/cm2
n=6 Participants
Single, intra-wound local administration of MBN-101; dosage = 1.5 µg/cm2; randomized 3:1 with placebo
|
MBN-101 5.0 µg/cm2
n=6 Participants
Single, intra-wound local administration of MBN-101; dosage = 5.0 µg/cm2; randomized 3:1 with placebo
|
Placebo
n=7 Participants
The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient. Placebo was randomized 1:3 with active drug product treatment Cohorts 1-3
|
|---|---|---|---|---|
|
Number of Treatment Failures
|
1 Treatment failure events
|
2 Treatment failure events
|
1 Treatment failure events
|
3 Treatment failure events
|
SECONDARY outcome
Timeframe: Up to 12weeksTreatment failure in subjects with baseline infections resistant to one or more antibiotics based on Central Laboratory Microbiological data
Outcome measures
| Measure |
MBN-101 0.5 µg/cm2
n=4 Participants
Single, intra-wound local administration of MBN-101; dosage = 0.5 µg/cm2; randomized 3:1 with placebo
|
MBN-101 1.5 µg/cm2
n=5 Participants
Single, intra-wound local administration of MBN-101; dosage = 1.5 µg/cm2; randomized 3:1 with placebo
|
MBN-101 5.0 µg/cm2
n=4 Participants
Single, intra-wound local administration of MBN-101; dosage = 5.0 µg/cm2; randomized 3:1 with placebo
|
Placebo
n=4 Participants
The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient. Placebo was randomized 1:3 with active drug product treatment Cohorts 1-3
|
|---|---|---|---|---|
|
Treatment Failure in Subjects With Antibiotic-resistant Infections
|
1 Failures in antibiotic-resistant subject
|
2 Failures in antibiotic-resistant subject
|
1 Failures in antibiotic-resistant subject
|
2 Failures in antibiotic-resistant subject
|
Adverse Events
MBN-101 0.5 µg/cm2
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
MBN-101 1.5 µg/cm2
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
MBN-101 5.0 µg/cm2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MBN-101 0.5 µg/cm2
n=6 participants at risk
Single, intra-wound local administration of MBN-101; dosage = 0.5 µg/cm2; randomized 3:1 with placebo
MBN-101: MBN-101 is a locally administered, anti-infective drug product
|
MBN-101 1.5 µg/cm2
n=6 participants at risk
Single, intra-wound local administration of MBN-101; dosage = 1.5 µg/cm2; randomized 3:1 with placebo
MBN-101: MBN-101 is a locally administered, anti-infective drug product
|
MBN-101 5.0 µg/cm2
n=6 participants at risk
Single, intra-wound local administration of MBN-101; dosage = 5.0 µg/cm2; randomized 3:1 with placebo
MBN-101: MBN-101 is a locally administered, anti-infective drug product
|
Placebo
n=7 participants at risk
Placebo: The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient. Placebo subjects were randomized 1:3 with subjects treated with active drug product in Cohorts 1-3.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Cardiac disorders
Cardiac failure
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Cardiac disorders
Myocardial ischemia
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Product Issues
Device failure
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Infections and infestations
Osteomyelitis
|
33.3%
2/6 • Number of events 2 • 12 weeks
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
14.3%
1/7 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Tibia fracture
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Wound dehiscence
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Product Issues
Drug hypersensitivity
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Injury, poisoning and procedural complications
Serious injury
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Injury, poisoning and procedural complications
Hematoma
|
0.00%
0/6 • 12 weeks
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/6 • 12 weeks
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Deep vein thrombosis
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
14.3%
1/7 • Number of events 1 • 12 weeks
|
|
Infections and infestations
C. difficile infection
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
14.3%
1/7 • Number of events 1 • 12 weeks
|
|
Blood and lymphatic system disorders
Septic shock
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Blood and lymphatic system disorders
Linear Immunoglobulin A disease
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
Other adverse events
| Measure |
MBN-101 0.5 µg/cm2
n=6 participants at risk
Single, intra-wound local administration of MBN-101; dosage = 0.5 µg/cm2; randomized 3:1 with placebo
MBN-101: MBN-101 is a locally administered, anti-infective drug product
|
MBN-101 1.5 µg/cm2
n=6 participants at risk
Single, intra-wound local administration of MBN-101; dosage = 1.5 µg/cm2; randomized 3:1 with placebo
MBN-101: MBN-101 is a locally administered, anti-infective drug product
|
MBN-101 5.0 µg/cm2
n=6 participants at risk
Single, intra-wound local administration of MBN-101; dosage = 5.0 µg/cm2; randomized 3:1 with placebo
MBN-101: MBN-101 is a locally administered, anti-infective drug product
|
Placebo
n=7 participants at risk
Placebo: The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient. Placebo subjects were randomized 1:3 with subjects treated with active drug product in Cohorts 1-3.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
28.6%
2/7 • Number of events 2 • 12 weeks
|
|
Infections and infestations
Osteomyelitis
|
33.3%
2/6 • Number of events 2 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
14.3%
1/7 • Number of events 1 • 12 weeks
|
|
Blood and lymphatic system disorders
Increased measurement of systemic C-reactive protein
|
33.3%
2/6 • Number of events 2 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Blood and lymphatic system disorders
Increased measurement of systemic red blood cell sedimentation rate
|
33.3%
2/6 • Number of events 2 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
0.00%
0/7 • 12 weeks
|
|
Infections and infestations
Infection
|
0.00%
0/6 • 12 weeks
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/6 • 12 weeks
|
42.9%
3/7 • Number of events 3 • 12 weeks
|
|
Blood and lymphatic system disorders
Blood alkaline phosphatase increased
|
33.3%
2/6 • Number of events 2 • 12 weeks
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
14.3%
1/7 • Number of events 1 • 12 weeks
|
Additional Information
Brett Baker, President and Chief Innovation Officer
Microbion Corporation
Phone: 4065991190
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place