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
Overview
- Phase
- Phase 2
- Intervention
- Debio 1450 IV
- Conditions
- Bacterial Infections
- Sponsor
- Debiopharm International SA
- Enrollment
- 330
- Locations
- 22
- Primary Endpoint
- Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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:
- •the safety or well-being of the participant or study staff;
- •the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
- •the analysis of results
Arms & Interventions
Debio 1450 320/480 mg
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).
Intervention: Debio 1450 IV
Debio 1450 320/480 mg
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).
Intervention: Debio 1450 Oral
Debio 1450 320/480 mg
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).
Intervention: Linezolid Placebo
Debio 1450 160/240 mg
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.
Intervention: Debio 1450 IV
Debio 1450 160/240 mg
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.
Intervention: Debio 1450 Oral
Debio 1450 160/240 mg
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.
Intervention: Debio 1450 Oral Placebo
Debio 1450 160/240 mg
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.
Intervention: Linezolid Placebo
Placebo
After 2 doses of Vancomycin IV, the Placebo comparator group receives Debio 1450 Oral Placebo + Linezolid 600 mg BID.
Intervention: Linezolid
Placebo
After 2 doses of Vancomycin IV, the Placebo comparator group receives Debio 1450 Oral Placebo + Linezolid 600 mg BID.
Intervention: Debio 1450 Oral Placebo
Placebo
After 2 doses of Vancomycin IV, the Placebo comparator group receives Debio 1450 Oral Placebo + Linezolid 600 mg BID.
Intervention: Vancomycin IV
Outcomes
Primary Outcomes
Early Clinical Response Rate (ECRR): 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 (Day 4)
ECRR was defined as the percentage of responders to treatment at 48 to 72 hours from randomization. Responders were the participants who showed greater than or equal to (≥) 20% reduction in area of the primary lesion involving erythema, edema, or induration of the primary ABSSSI lesion (as assessed by the ruler method) at 48 to 72 hours compared to baseline.
Secondary Outcomes
- Clinical Success Rate: Percentage of Participants Assessed by the Sponsor as Responders After 7 to 10 Days of Treatment at EOT and STFU(EOT (Day 12) and STFU (Day 19))
- Clinical Success Rate: Percentage of Participants Assessed by the Investigator as Responders at 48 to 72 Hours From Randomization, at End of Treatment (EOT) and Short-term Follow-up (STFU)(48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19))
- Percentage of Participants With a Composite Assessment of Clinical Outcome (CACO) of Success(48 to 72 hours after randomization (Day 4) and STFU (Day 19))
- Percentage of Participants Who Showed Microbiological Evidence of Cure 48 to 72 Hours From Randomization, EOT, and STFU(48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19))