Overview

This trial has been completed.

Condition bacterial infections
Treatments debio 1450 iv, debio 1450 oral, linezolid, debio 1450 oral placebo, linezolid placebo, vancomycin iv
Phase phase 2
Sponsor Debiopharm International SA
Start date May 2015
End date August 2016
Trial size 330 participants
Trial identifier NCT02426918, 218187, Debio 1450-ABSSSI-201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
After 2 doses of Debio 1450 IV (intravenous) therapy, the Debio 1450 320/480 mg daily dose group receives 240 mg Debio 1450 Oral + Linezolid Placebo twice daily (BID).
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).
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).
linezolid placebo
Linezolid placebo will be supplied as film-coated compressed tablets.
(Experimental)
After 2 doses of Debio 1450 IV therapy, the Debio 1450 160/240 mg daily dose group receives 120 mg Debio 1450 Oral + Debio 1450 Oral Placebo + Linezolid Placebo BID.
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).
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).
debio 1450 oral placebo
Debio 1450 placebo will be supplied as white, opaque, hard gelatin capsules.
(Placebo Comparator)
After 2 doses of Vancomycin IV, the Placebo comparator group receives Debio 1450 Oral Placebo + Linezolid 600 mg BID.
linezolid
Linezolid for oral administration will be provided as 600-mg film-coated compressed tablets.
debio 1450 oral placebo
Debio 1450 placebo will be supplied as white, opaque, hard gelatin capsules.
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.

Primary Outcomes

Measure
Early Clinical Response Rate: percentage of responders to treatment at 48 to 72 hours from randomization as assessed by the Investigator
time frame: at 48 to 72 hours from randomization

Secondary Outcomes

Measure
Clinical Success Rate: Percentage of participants assessed by the investigator as responders after 7 to 14 days of treatment
time frame: after 7 to 14 days of treatment
Clinical success rate: Percentage of participants assessed by the sponsor as responders after 7 to 14 days of treatment
time frame: after 7 to 14 days of treatment
Percentage of participants with a Composite Assessment of Clinical Outcome (CACO) of success after 7 to 14 days of treatment
time frame: after 7 to 14 days of treatment
Percentage of patients who show microbiological evidence of cure after 7 to 14 days of treatment
time frame: after 7 to 14 days of treatment

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Has clinically documented infection of the skin or skin structure suspected or documented to be caused by a staphylococcal pathogen - Meets other protocol-specified criteria for qualification and contraception - Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications - Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures Exclusion Criteria: - Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters - Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1. the safety or well-being of the participant or study staff; 2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3. the analysis of results

Additional Information

Official title A Phase 2, Randomized, Double-Blind, Multicenter Study of Safety, Tolerability, and Efficacy of Debio 1450 vs Vancomycin (IV)/Linezolid (Oral) in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Due to Staphylococcus Sensitive or Resistant to Methicillin
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Debiopharm International SA.