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Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection

NCT02925416 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-02-01

Study results available
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Summary

The purpose of this study was to evaluate the safety and tolerability of two 1200 milligram (mg) intravenous (IV) infusions of oritavancin when administered one week apart.

Conditions

  • Skin Diseases, Bacterial

Interventions

DRUG

Oritavancin

Administered intravenously

DRUG

Placebo (D5W)

Administered intravenously

Sponsors & Collaborators

  • The Medicines Company

    lead INDUSTRY

Principal Investigators

  • Medical Information · Melinta Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-24
Primary Completion
2017-06-20
Completion
2017-06-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02925416 on ClinicalTrials.gov