CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
MBN-101 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02436876
NCT02436876Phase 2Completed
CompareCT.gov

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

Microbion Corporation·interventional·Posted May 7, 2015·Updated Sep 30, 2021

In Brief

A Phase 2 clinical trial evaluating MBN-101 and Placebo for Bacterial Infection. Completed, enrolled 29 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacterial Infection
CountriesUnited States
CollaboratorsUniversity of Pennsylvania, University of California, San Francisco, Medpace, Inc., Congressionally Directed Medical Research Programs

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 7, 2015
Enrollment StartMay 24, 2016
Primary CompletionOct 27, 2017
Study CompletionJul 26, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.2 years ago

Interventions

MBN-101drug

MBN-101 is a locally administered, anti-infective drug product

Placeboother

The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient