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Study of Debio 1450 for Bacterial Skin Infections

NCT02426918 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2019-11-13

Study results available
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Summary

The primary objective of this study is to evaluate the efficacy of 2 different doses of intravenous and oral Debio 1450 compared with intravenous vancomycin and oral linezolid in the treatment of patients with staphylococcal ABSSSI.

Conditions

Interventions

DRUG

Debio 1450 IV

Intravenous (IV) form of Debio 1450 will be supplied in vials containing 50 mg of active pharmaceutical ingredient (API). Intravenous infusions of Debio 1450 (160 mg and 80 mg) will be administered over a 2-hour period BID every 12 hours within a 2-hour window (12 ± 2 hours).

DRUG

Debio 1450 Oral

Oral forms of Debio 1450 will be provided as white, opaque, hard gelatin capsules containing 50 mg drug substance (equivalent to 40 mg of Debio 1450).

DRUG

Linezolid

Linezolid for oral administration will be provided as 600-mg film-coated compressed tablets.

DRUG

Debio 1450 Oral Placebo

Debio 1450 placebo will be supplied as white, opaque, hard gelatin capsules.

DRUG

Linezolid Placebo

Linezolid placebo will be supplied as film-coated compressed tablets.

DRUG

Vancomycin IV

Vancomycin will be administered BID every 12 ± 2 hours at doses of 1 g or 15 mg/kg as specified in local protocols, with the infusion rate adjusted to 2 hours.

Sponsors & Collaborators

  • Debiopharm International SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-08-31
Completion
2016-09-30

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT02426918 on ClinicalTrials.gov