Phase 2
Completed N=330
Study of Debio 1450 for Bacterial Skin Infections
Source: ClinicalTrials.gov NCT02426918 ↗Enrolled (actual)
330
Serious AEs
1.2%
Results posted
Nov 2019
Primary outcomePrimary: Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator — 94.6; 90.1; 91.1 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator |
94.6; 90.1; 91.1 | — |
| SECONDARY 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) |
83.7; 81.3; 86.1; 92.4; 87.9; 92.1 | — |
| SECONDARY Clinical Success Rate: Percentage of Participants Assessed by the Sponsor as Responders After 7 to 10 Days of Treatment at EOT and STFU |
89.1; 86.8; 90.1; 81.5; 81.3; 90.1 | — |
| SECONDARY Percentage of Participants With a Composite Assessment of Clinical Outcome (CACO) of Success |
83.7; 81.3; 88.1 | — |
| SECONDARY Percentage of Participants Who Showed Microbiological Evidence of Cure 48 to 72 Hours From Randomization, EOT, and STFU |
72.8; 69.2; 75.2; 92.4; 86.8; 91.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT02426918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.