Study of Debio 1450 for Bacterial Skin Infections

Debiopharm

Status and phase: Completed; Phase 2

Conditions: Bacterial Infections

Treatments: Drug: Vancomycin IV; Drug: Linezolid; Drug: Linezolid Placebo; Drug: Debio 1450 IV; Drug: Debio 1450 Oral Placebo; Drug: Debio 1450 Oral

Study type: Interventional

Funder types: Industry

Identifiers

NCT02426918

218187 (Other Identifier)

Debio 1450-ABSSSI-201

Details and patient eligibility

About

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.

Enrollment: 330 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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330 participants in 3 patient groups, including a placebo group

Debio 1450 320/480 mg

Experimental group

Description:

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).

Treatment:

Drug: Debio 1450 Oral

Drug: Debio 1450 IV

Drug: Linezolid Placebo

Debio 1450 160/240 mg

Experimental group

Description:

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.

Treatment:

Drug: Debio 1450 Oral

Drug: Debio 1450 Oral Placebo

Drug: Debio 1450 IV

Drug: Linezolid Placebo

Placebo

Placebo Comparator group

Description:

After 2 doses of Vancomycin IV, the Placebo comparator group receives Debio 1450 Oral Placebo + Linezolid 600 mg BID.

Treatment:

Drug: Debio 1450 Oral Placebo

Drug: Linezolid

Drug: Vancomycin IV