Conditions: Bacterial Infections
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 330
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: 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). arm 2: 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. arm 3: After 2 doses of Vancomycin IV, the Placebo comparator group receives Debio 1450 Oral Placebo + Linezolid 600 mg BID.

Interventions: intervention 1: Debio 1450 IV intervention 2: Debio 1450 Oral intervention 3: Linezolid intervention 4: Debio 1450 Oral Placebo intervention 5: Linezolid Placebo intervention 6: Vancomycin IV
Intervention descriptions: intervention 1: 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). intervention 2: 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). intervention 3: Linezolid for oral administration will be provided as 600-mg film-coated compressed tablets. intervention 4: Debio 1450 placebo will be supplied as white, opaque, hard gelatin capsules. intervention 5: Linezolid placebo will be supplied as film-coated compressed tablets. intervention 6: 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.

Protocol document: