Bacterial InfectionPhase 2NCT02436876
Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites
A Phase 2 study testing MBN-101 in people with Bacterial Infection, run by Microbion Corporation at 6 sites in United States.
Trial summary
This study evaluates the safety and clinical benefit of MBN-101 administered intraoperatively to osteosynthesis or osteomyelitis sites for patients diagnosed with an orthopedic infection, with or without orthopaedic hardware. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bacterial Infection
- What is being tested?
- MBN-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 6 sitesUnited States
- Study dates
- 24 May 2016to 26 Jul 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for this study, each of the following criteria must be satisfied with a "YES" answer (unless not applicable):
- Patients who:
- have had operative fracture fixation of the upper extremity (AO/OTA class 15, 11-13, 21-23), lower extremity (AO/OTA class 31-34, 41 44, 81, 82) or pelvis (61, 62), or have undergone arthrodesis, and have subsequently been diagnosed with an apparent fracture site infection or are diagnosed with chronic or acute-on-chronic osteomyelitis of the long bone extremities (including residual amputated limbs)
- have at least one of the following:
- require surgical debridement of infected soft tissue and/or bone, with or without removal and/or placement/replacement of hardware
- male or female between the ages of 18 and 75 at the time the ICF is reviewed and signed
Show all 10Show fewer
- patients receiving or anticipated to receive systemic antibiotic therapy as per institution's standard of care
- patients requiring postoperative hospitalization for at least 48 hours after revision surgery
- have read and signed the Informed Consent Form (ICF) after the nature of the study has been fully explained
- be willing and able to provide authorization for use and disclosure of personal health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA)
Who cannot join
- To be eligible for this study, each of the following criteria must be satisfied with a "NO" answer (unless not applicable):
- Patients who are no longer hardware dependent or are definitively treated for their infection by hardware removal without replacement
- Patients with multiple, non-contiguous sites of infection
- Pathologic fracture (not including osteoporosis)
- Patient requires immunosuppressive therapy (Topical or inhaled corticosteroids are permitted)
- Serum creatinine, ALT, AST or Alkaline Phosphatase >2.0 times the upper limit of the normal range of the local testing laboratory
Show all 19Show fewer
- Absolute neutrophil count <1000
- Patients without definitive soft-tissue coverage over the surgical site at time of study product administration
- Any condition that has required treatment with any other bismuth containing compound within the last 2 weeks (i.e., Kaopectate or Pepto Bismol)
- Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months
- Individuals undergoing surgical treatment for more than one infected site
- Patients who are pregnant, lactating, or female patients who have a positive serum hCG (human Chorionic Gonadotropin) as determined by laboratory testing
- Immunocompromised due to illness or organ transplant
- History of chronic or recurrent infections (≥ 3 infections at the same site within 12 months)
- History of any type of cancer (excluding non-melanomatous localized skin cancer or completely excised and cured carcinoma-in-situ of uterine cervix)
- Poorly controlled diabetes mellitus
- History of medical noncompliance
- Other medical conditions which, in the opinion of the Principal Investigator, would jeopardize the safety of the study subject or impact the validity of the study results.
- Current incarceration
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
LifeBridge Health, Inc.
Baltimore, Maryland, 21215
OhioHealth Research Institute
Columbus, Ohio, 443215
The University of Texas - Health Science Center & Medical School at Houston
Houston, Texas, 77030
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Orthopedic Trauma Institute, University of California San Francisco
San Francisco, California, 94110
UCSF - Parnassus
San Francisco, California, 94143
About this study
Official title: Phase 2a Randomized, Single-Blind, Placebo-Controlled, 12-week Escalating Dose Study to Assess the Safety, Tolerability and Clinical Activity of 3 Concentrations of Locally Applied MBN-101 to Infected Bone Sites
This study evaluates the safety and clinical benefit of MBN-101 administered intraoperatively to osteosynthesis or osteomyelitis sites for patients diagnosed with an orthopedic infection, with or without orthopaedic hardware. Three quarters of the patients will receive MBN-101, while the other one quarter will receive placebo.
Read the detailed description
Postoperative orthopaedic infections, particularly antibiotic-resistant infections, present a serious clinical challenge to surgeons and other treating physicians. These infections frequently involve implanted foreign materials (stabilizing orthopaedic hardware), making infection of these sites much more likely than if foreign materials were not involved. MBN-101 has broad spectrum antimicrobial activity against orthopaedic wound pathogens.
This is a randomized, single-blind, placebo-controlled, multi-center study to assess the safety and tolerability of escalating doses of MBN-101 to treat orthopaedic infections during revision surgery, (a) with or without orthopaedic hardware, and (b) with or without removal and replacement of orthopaedic hardware.
- Conditions
- Bacterial Infection
- Being tested
- MBN-101, Placebo
- Keywords
- Osteosynthesis, Complications, Infection or Inflammation, Orthopedic, Device, Fracture, Osteomyelitis
- Medical subject headings
- Bacterial Infections, Infections, Inflammation, Fractures, Bone, Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBN-101Drug
Also called MBN-101 Drug Product
MBN-101 is a locally administered, anti-infective drug product
PlaceboOther
Also called Diluent; Vehicle
The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Single, intra-wound local administration of MBN-101; dosage = 0.5 µg/cm2; randomized 3:1 with placebo Receives: Drug: MBN-101; Other: Placebo |
| Cohort 2 | Experimental | Single, intra-wound local administration of MBN-101; dosage = 1.5 µg/cm2; randomized 3:1 with placebo Receives: Drug: MBN-101; Other: Placebo |
| Cohort 3 | Experimental | Single, intra-wound local administration of MBN-101; dosage = 5.0 µg/cm2; randomized 3:1 with placebo Receives: Drug: MBN-101; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
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.
Measured: 12 weeks
Secondary outcomes (2)
Number of Treatment Failures
Treatment failure is defined as clinical course requiring additional infection-related interventions including rehospitalization, additional surgery, or additional courses of systemic antibiotics.
Measured: 12 weeks
Treatment Failure in Subjects With Antibiotic-resistant Infections
Treatment failure in subjects with baseline infections resistant to one or more antibiotics based on Central Laboratory Microbiological data
Measured: Up to 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study start24 May 2016
- Primary completion27 Oct 2017
- Study completion26 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bacterial InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microbion Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania, University of California, San Francisco, Medpace, Inc., Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Brett Baker, MSc, DC, Study chair, Microbion Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436876
- Sponsor's protocol ID
- MBN-101-201
- Other IDs
- W81XWH-12-2-0100
- Status last verified
- Sep 2021
- First submitted
- 28 Apr 2015
- Last updated
- 30 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Randomized, Single-Blind, Placebo-Controlled, 12-week Escalating Dose Study to Assess the Safety, Tolerability and Clinical Activity of 3 Concentrations of Locally Applied MBN-101 to Infected Bone Sites
- ClinicalTrials.gov ID
- NCT02436876
- Acronym / sponsor ID
- MBN-101-201
- Conditions
- Bacterial Infection
- Keywords
- Osteosynthesis, Complications, Infection or Inflammation, Orthopedic, Device, Fracture, Osteomyelitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Microbion CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania, University of California, San Francisco, Medpace, Inc., Congressionally Directed Medical Research Programs
- Study start
- 24 May 2016 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 7 May 2015 (estimated)
- Results
- Posted 30 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety and clinical benefit of MBN-101 administered intraoperatively to osteosynthesis or osteomyelitis sites for patients diagnosed with an orthopedic infection, with or without orthopaedic hardware. Three quarters of the patients will receive MBN-101, while the other one quarter will receive placebo.
Detailed description
Postoperative orthopaedic infections, particularly antibiotic-resistant infections, present a serious clinical challenge to surgeons and other treating physicians. These infections frequently involve implanted foreign materials (stabilizing orthopaedic hardware), making infection of these sites much more likely than if foreign materials were not involved. MBN-101 has broad spectrum antimicrobial activity against orthopaedic wound pathogens.
This is a randomized, single-blind, placebo-controlled, multi-center study to assess the safety and tolerability of escalating doses of MBN-101 to treat orthopaedic infections during revision surgery, (a) with or without orthopaedic hardware, and (b) with or without removal and replacement of orthopaedic hardware.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: MBN-101, Other: PlaceboSingle, intra-wound local administration of MBN-101; dosage = 0.5 µg/cm2; randomized 3:1 with placebo |
| Cohort 2 | Experimental | Drug: MBN-101, Other: PlaceboSingle, intra-wound local administration of MBN-101; dosage = 1.5 µg/cm2; randomized 3:1 with placebo |
| Cohort 3 | Experimental | Drug: MBN-101, Other: PlaceboSingle, intra-wound local administration of MBN-101; dosage = 5.0 µg/cm2; randomized 3:1 with placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- To be eligible for this study, each of the following criteria must be satisfied with a "YES" answer (unless not applicable):
- have had operative fracture fixation of the upper extremity (AO/OTA class 15, 11-13, 21-23), lower extremity (AO/OTA class 31-34, 41 44, 81, 82) or pelvis (61, 62), or have undergone arthrodesis, and have subsequently been diagnosed with an apparent fracture site infection or are diagnosed with chronic or acute-on-chronic osteomyelitis of the long bone extremities (including residual amputated limbs)
- have at least one of the following:
- require surgical debridement of infected soft tissue and/or bone, with or without removal and/or placement/replacement of hardware
- male or female between the ages of 18 and 75 at the time the ICF is reviewed and signed
Key exclusion criteria (19 listed)
- To be eligible for this study, each of the following criteria must be satisfied with a "NO" answer (unless not applicable):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBN-101Also: MBN-101 Drug ProductMBN-101 is a locally administered, anti-infective drug product | Drug | Cohort 1, Cohort 2, Cohort 3 |
| PlaceboAlso: Diluent; VehicleThe placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient | Other | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Number of Participants With Adverse Events
Time frame: 12 weeks
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.
2 secondary outcomes
Number of Treatment Failures
Time frame: 12 weeks
Treatment Failure in Subjects With Antibiotic-resistant Infections
Time frame: Up to 12weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett Baker, MSc, DC study chair
Microbion Corporation
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MBN-101 in people with Bacterial Infection, run by Microbion Corporation at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.