NCT02452918

A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

Completed Phase 4 Results posted Last updated 20 December 2023

What this trial tests

Phase 4 trial testing Oritavancin in Acute Bacterial Skin and Skin Structure Infection in 17 participants. Completed in 5 July 2016.

Timeline

29 September 2015

Primary endpoint
5 July 2016

5 July 2016

Quick facts

Lead sponsor	The Medicines Company
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	29 September 2015
Primary completion	5 July 2016
Estimated completion	5 July 2016
Sites	1 location across United States

Drugs / interventions tested

• Oritavancin (ORITAVANCIN) — full drug profile →
• Warfarin (warfarin) — full drug profile →

Conditions studied

• Acute Bacterial Skin and Skin Structure Infection — all drugs for Acute Bacterial Skin and Skin Structure Infection →

Sponsor

The Medicines Company — full company profile →

Who can join

18 and older, any sex, with Acute Bacterial Skin and Skin Structure Infection. 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 Adverse Events (AEs) and Serious Adverse Events (SAEs) Primary · Up to 2 weeks after first administration of oritavancin

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment, including abnormal vital signs or laboratory assessments. An SAE was defined as any untoward medical occurrence that at any dose resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect,

At least 1 AE

Group	Value	95% CI
Oritavancin 1200 mg Without Concomitant Warfarin Therapy	2
Oritavancin 1200 mg With Concomitant Warfarin Therapy	1

At least 1 SAE

Group	Value	95% CI
Oritavancin 1200 mg Without Concomitant Warfarin Therapy	0
Oritavancin 1200 mg With Concomitant Warfarin Therapy	0

Number of Participants With a Clinical Response of Cure Secondary · At 48 to 72 hours after start of oritavancin dose and at Day 7

Participants were classified by investigator assessment as "success" for clinical response of cure if all of the following were met: cessation of spread or reduction of the lesion; resolution (absence) of fever (temperature less than 37.7° Celsius); no rescue antibiotic medication; complete or nearly complete resolution of baseline signs and symptoms of the primary infection such that no further treatment with antibiotics was needed.

Group	Value	95% CI
Oritavancin 1200 mg Without Concomitant Warfarin Therapy	15
Oritavancin 1200 mg With Concomitant Warfarin Therapy	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 2 weeks after first administration of oritavancin. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Oritavancin 1200 mg Without Concomitant Warfarin Therapy

Serious: 0/15 (0%)

Deaths: 0/15

Oritavancin 1200 mg With Concomitant Warfarin Therapy

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (4 terms — click to expand)

Reaction	System	Oritavancin 1200 mg Withou…	Oritavancin 1200 mg With C…
Infusion site phlebitis	General disorders	—	—
Subcutaneous hematoma	Injury, poisoning and procedural complications	—	—
Nausea	Gastrointestinal disorders	—	—
Infusion site pain	General disorders	—	—

Data from ClinicalTrials.gov NCT02452918 adverse events section.

Sponsor's own description

This was a Phase 4, multicenter, open-label safety study of a single 1200 milligrams (mg) IV infusion of oritavancin in adult participants on chronic warfarin with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens.

An additional group of participants with ABSSSI, who were not on concomitant warfarin therapy, were also enrolled to obtain additional information following a single dose of oritavancin administration.

Publications & conference data

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

1. New Gram-Positive Agents: the Next Generation of Oxazolidinones and Lipoglycopeptides.
   Crotty MP, Krekel T, Burnham CA, Ritchie DJ. · · 2016 · cited 31× · PMID 26962092 · DOI 10.1128/jcm.03395-15