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NCT02436876 · ClinicalTrials.gov registry record · Phase 2
Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites
A Phase 2 study of Bacterial Infection, sponsored by Microbion Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 6
- Study locations
NCT02436876: Completed Phase 2 study of Bacterial Infection, sponsored by Microbion Corporation.
NCT02436876 is a Phase 2 study of Bacterial Infection that has completed, run by Microbion Corporation. The registered enrollment target is 29 participants, below the 102-participant average among 8 other Bacterial Infection trials with a reported enrollment target (72% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02436876, a Phase 2 study of Bacterial Infection, has completed, sponsored by Microbion Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
- 6
- Study locations
Study 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. Three quarters of the patients will receive MBN-101, while the other one quarter will receive placebo.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG MBN-101
Study Locations (6)
California
- Orthopedic Trauma Institute, University of California San Francisco - San Francisco
- UCSF - Parnassus - San Francisco
Maryland
- LifeBridge Health, Inc. - Baltimore
Ohio
- OhioHealth Research Institute - Columbus
Pennsylvania
- University of Pennsylvania - Philadelphia
Texas
- The University of Texas - Health Science Center & Medical School at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2016-05-24 |
| Est. Completion | 2018-07-26 |
| Phase | Phase 2 |
What the finished NCT02436876 record still lists
NCT02436876 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 102-participant average among 8 other Bacterial Infection trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Bacterial Infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02436876 lists 6 locations in 5 states (California, Maryland, Ohio).
Frequently Asked Questions
What is clinical trial NCT02436876 about?
NCT02436876 is a clinical study titled "Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of 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 q...
What is the current status of trial NCT02436876?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2016-05-24. Estimated completion is 2018-07-26.
What conditions does trial NCT02436876 study?
This clinical trial studies the following conditions: Bacterial Infection.
What interventions are being tested in trial NCT02436876?
The interventions under investigation include: Placebo (OTHER), MBN-101 (DRUG).
Who is sponsoring clinical trial NCT02436876?
This trial is sponsored by Microbion Corporation, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02436876 being conducted?
This trial has 6 study locations across California, Maryland, Ohio, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bacterial Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02436876's enrollment target sits among peer trials
29 8th of 8 higher than 1 of 8 other Bacterial Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bacterial Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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