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NCT02168816 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for Osteomyelitis
A Phase 2 study, sponsored by Loyola University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT02168816: Clinical Trial Phase 2 study, sponsored by Loyola University.
NCT02168816 is a Phase 2 study that was terminated before completion, run by Loyola University. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02168816, a Phase 2 study, was terminated before completion, sponsored by Loyola University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The Infectious Diseases Society of America (IDSA) 2012 guidelines for the diagnosis and treatment of diabetic foot infections state that for the treatment of diabetic foot osteomyelitis "No data support the superiority of any specific antibiotic agent or treatment strategy, route, or duration of therapy." Traditionally, osteomyelitis has been treated with a long course of intravenous antibiotics, generally six weeks. Oral antibiotics with high bioavailability and adequate bone penetration have been shown in published studies to be effective for the treatment of osteomyelitis. The investigators propose to conduct a prospective, single-center, randomized, open trial at Loyola University Medical Center (LUMC) comparing the efficacy of oral antibiotic therapy to intravenous (IV) antibiotic therapy for the treatment of diabetic foot osteomyelitis. The investigators hypothesize that oral antibiotic therapy is equivalent to IV antibiotic therapy. Bone/tissue cultures are obtained for all patients for clinical purposes and are sent to pathology for histologic examination and to the clinical microbiology laboratory for culture and susceptibility. Patients will receive six weeks of IV or oral antibiotic therapy depending upon their randomization group. Primary outcomes at six months clinical follow-up will include: (i) no evidence of bone infection and (ii) resolution of ulcer.
Primary Outcome
Six months following completion of treatment, the researchers record evidence of bone infection for each participant. A negative diagnosis is made when there is (i) an absence of infection based on clinical examination and (ii) down-trending of inflammatory markers. Otherwise, a positive diagnosis is made.
Interventions
- DRUG Intravenous Antibacterial Agent
- DRUG Oral Antibacterial Agent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-03-19 |
| Est. Completion | 2017-02-02 |
| Phase | Phase 2 |
Why NCT02168816 stopped before completion
NCT02168816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Intravenous Antibacterial Agent is the first listed.
NCT02168816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02168816 about?
NCT02168816 is a clinical study titled "Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for Osteomyelitis". The Infectious Diseases Society of America (IDSA) 2012 guidelines for the diagnosis and treatment of diabetic foot infections state that for the treatment of diabetic foot osteomyelitis "No data support the superiority of any specific antibiotic agent or treatment strategy, route, or duration of the...
What is the current status of trial NCT02168816?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2014-03-19. Estimated completion is 2017-02-02.
What interventions are being tested in trial NCT02168816?
The interventions under investigation include: Intravenous Antibacterial Agent (DRUG), Oral Antibacterial Agent (DRUG).
Who is sponsoring clinical trial NCT02168816?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02168816's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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