Study of Debio 1450 for Bacterial Skin Infections

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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:

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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