NCT03091439

Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis

Terminated Phase 2 Results posted Last updated 26 September 2018

What this trial tests

Phase 2 trial testing Dalbavancin in Osteomyelitis in 1 participant. Terminated before completion.

Timeline

15 May 2017

Primary endpoint
31 August 2017

31 August 2017

Quick facts

Lead sponsor	Allergan
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	15 May 2017
Primary completion	31 August 2017
Estimated completion	31 August 2017
Sites	1 location across United States

Drugs / interventions tested

• Dalbavancin (DALBAVANCIN) — full drug profile →
• Standard of Care

Conditions studied

• Osteomyelitis — all drugs for Osteomyelitis →

Sponsor

Allergan — full company profile →

Who can join

18 and older, any sex, with Osteomyelitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population Primary · Day 42

Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring \> 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency. The number of participants in each response category is reported.

Group	Value	95% CI
Dalbavancin	1
Standard of Care	0
Dalbavancin	0
Standard of Care	0
Dalbavancin	0
Standard of Care	0

Number of Participants With Clinical Improvement at Day 28 in the Modified Intent-to-Treat (mITT) Population Secondary · Baseline (Day 0) to Day 28

Clinical improvement was based on an assessment of pain and/or point tenderness compared to Baseline and assessment of inflammation as measured by C-reactive Protein (CRP). Clinical improvement was defined as no worsening of pain from Baseline, if present, and improvement in inflammation.

Group	Value	95% CI
Dalbavancin	1

Number of Participants With Clinical Improvement at Day 28 in the CE Population Secondary · Baseline (Day 0) to Day 28

Clinical improvement was based on an assessment of pain and/or point tenderness compared to Baseline and assessment of inflammation as measured by C-reactive Protein (CRP). Clinical improvement was defined as no worsening of pain from Baseline, if present, and improvement in inflammation.

Group	Value	95% CI
Dalbavancin	1
Standard of Care	0

Number of Participants With Clinical Response at Day 42 in the mITT Population Secondary · Day 42

Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring \> 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.

Group	Value	95% CI
Dalbavancin	1
Standard of Care	0
Dalbavancin	0
Standard of Care	0
Dalbavancin	0
Standard of Care	0

Sponsor's own description

This clinical study will be a multi-center, randomized, open-label, active-controlled, parallel-group study comparing dalbavancin to standard of care (SOC) therapy in osteomyelitis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Multiple-Dose Dalbavancin Regimens as the Predominant Treatment of Deep-Seated or Endovascular Infections: A Scoping Review.
   Cooper MM, Preslaski CR, Shihadeh KC, Hawkins KL, et al · · 2021 · cited 20× · PMID 34738025 · DOI 10.1093/ofid/ofab486