Trial · NCT02426918
Study of Debio 1450 for Bacterial Skin Infections
NCT02426918, Phase 2, Completed, Debiopharm International SA; results first posted 2019-11-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Debio 1450 for Bacterial Skin Infections. Trials, record NCT02426918. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02426918
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Debio 1450 for Bacterial Skin Infections
- NCT number
- NCT02426918
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 330 participants, actual
- Lead sponsor
- Debiopharm International SA
- Conditions
- Bacterial Infections
- Interventions
- Debio 1450 IV, Debio 1450 Oral, Linezolid, Debio 1450 Oral Placebo, Linezolid Placebo, Vancomycin IV
- First posted
- 2015-04-27
- Last updated
- 2019-11-13
- Results first posted
- 2019-11-13
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator | 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 | 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) | The Investigator Assessment of Clinical Outcome (IACO) of treatment was assessed for each participant as success or failure at 48 to 72 hours after randomization at EOT and STFU visits. Clinical success was resolution or near resolution of most disease-specific signs and symptoms and no new signs, symptoms, or complications attributable to ABSSSI such that no further antibiotic therapy is required for treatment of original site of infection. Clinical failure was requirement for additional antibiotic therapy for treatment of the original site of infection or incision and drainage of ABSSSI site that was not both anticipated and completed within a 48- to 72-hour window following randomization, or unplanned major surgical intervention required due to failure of study medication or development of osteomyelitis after baseline. Participants who met both success criteria and none of failure criteria were considered as a clinical success for IACO. |
| Secondary | 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) | The Sponsor's Assessment of Clinical Outcome was obtained at EOT and STFU visits based on IACO and additional criteria. Sponsor assessed participants as clinical failure if they required non-study or rescue antibiotics due to lack of efficacy after at least 48 hours from randomization or experienced drug-related serious adverse events (SAEs) or discontinuation of study medication for drug-related AEs or required antibiotic therapy for longer than 10 days or had the need for unplanned surgical intervention \>48 hours after randomization. As per IACO, clinical success was resolution or near resolution of most disease-specific signs and symptoms and no new signs, symptoms or complications. Clinical failure was requirement for additional antibiotic therapy or incision and drainage of ABSSSI site or unplanned major surgical intervention or development of osteomyelitis. |
| Secondary | 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) | CACO of treatment was determined as a combined outcome of early response to treatment (at 48 to 72 hours from randomization) and IACO at the STFU visit. Participants had a CACO of success if they met both of the following criteria: An early response to treatment (at 48 to 72 hours from randomization) (ECR = responder) and a clinical outcome of success at the STFU visit (7 to 14 days after EOT) based on IACO (IACO = success). |
| Secondary | 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) | The microbiological outcome was assessed by the sponsor at 48 to 72 hours from randomization, EOT and STFU. It was based on blood and skin lesion identification results from baseline samples and skin lesion identification results from baseline samples and skin lesion identification results from follow-up samples as well as on, molecular typing results, and the IACO. Microbiological eradication rate was defined as proportion of participants with 'Documented Eradication' (absence of baseline pathogen(s) in follow-up cultures of the original site of infection.) or 'Presumed Eradication' (no material available for culture and an IACO of 'Success') in relation to the total number of participants in the respective treatment group. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator | At 48 to 72 hours from randomization (Day 4) | Microbiological Intent-to-Treat (mITT) population included all randomized participants who were culture positive for any staphylococcal species considered pathogenic and received at least one dose of study medication. | percentage of participants | NUMBER |
| 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) | 48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19) | mITT population included all randomized participants who were culture positive for any staphylococcal species considered pathogenic and received at least one dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | 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) | mITT population included all randomized participants who were culture positive for any staphylococcal species considered pathogenic and received at least one dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | 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) | mITT population included all randomized participants who were culture positive for any staphylococcal species considered pathogenic and received at least one dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | 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) | mITT population included all randomized participants who were culture positive for any staphylococcal species considered pathogenic and received at least one dose of study medication. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator | Debio 1450 80 mg/120 mg BID | 94.6 | percentage of participants | ||
| Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator | Debio 1450 160 mg/240 mg BID | 90.1 | percentage of participants | ||
| Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator | Vancomycin/Linezolid BID | 91.1 | percentage of participants | ||
| 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) | Debio 1450 80 mg/120 mg BID | 48 to 72 hours after randomization | 83.7 | percentage of participants | |
| 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) | Debio 1450 160 mg/240 mg BID | 48 to 72 hours after randomization | 81.3 | percentage of participants | |
| 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) | Vancomycin/Linezolid BID | 48 to 72 hours after randomization | 86.1 | percentage of participants | |
| 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) | Debio 1450 80 mg/120 mg BID | EOT | 92.4 | percentage of participants | |
| 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) | Debio 1450 160 mg/240 mg BID | EOT | 87.9 | percentage of participants | |
| 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) | Vancomycin/Linezolid BID | EOT | 92.1 | percentage of participants | |
| 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) | Debio 1450 80 mg/120 mg BID | STFU | 84.8 | percentage of participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Debio 1450 80 mg (Milligrams)/120 mg BID | 110 | |
| Overall Study | STARTED | Debio 1450 160 mg/240 mg BID | 109 | |
| Overall Study | STARTED | Vancomycin/Linezolid BID | 111 | |
| Overall Study | Safety Population | Debio 1450 80 mg (Milligrams)/120 mg BID | 110 | |
| Overall Study | Safety Population | Debio 1450 160 mg/240 mg BID | 107 | |
| Overall Study | Safety Population | Vancomycin/Linezolid BID | 107 | |
| Overall Study | COMPLETED | Debio 1450 80 mg (Milligrams)/120 mg BID | 93 | |
| Overall Study | COMPLETED | Debio 1450 160 mg/240 mg BID | 90 | |
| Overall Study | COMPLETED | Vancomycin/Linezolid BID | 97 | |
| Overall Study | NOT COMPLETED | Debio 1450 80 mg (Milligrams)/120 mg BID | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Debio 1450 80 mg/120 mg BID | 3 | 110 | |
| other | Diarrhoea | Gastrointestinal disorders | Debio 1450 160 mg/240 mg BID | 3 | 107 | |
| other | Diarrhoea | Gastrointestinal disorders | Vancomycin/Linezolid BID | 6 | 107 | |
| other | Nausea | Gastrointestinal disorders | Debio 1450 80 mg/120 mg BID | 7 | 110 | |
| other | Nausea | Gastrointestinal disorders | Debio 1450 160 mg/240 mg BID | 9 | 107 | |
| other | Nausea | Gastrointestinal disorders | Vancomycin/Linezolid BID | 7 | 107 | |
| other | Vomiting | Gastrointestinal disorders | Debio 1450 80 mg/120 mg BID | 1 | 110 | |
| other | Vomiting | Gastrointestinal disorders | Debio 1450 160 mg/240 mg BID | 6 | 107 | |
| other | Vomiting | Gastrointestinal disorders | Vancomycin/Linezolid BID | 2 | 107 | |
| other | Abscess | Infections and infestations | Debio 1450 80 mg/120 mg BID | 3 | 110 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Debio 1450 80 mg/120 mg BID | ||
| Total, all-cause mortality | Debio 1450 160 mg/240 mg BID | ||
| Total, all-cause mortality | Vancomycin/Linezolid BID | ||
| Total, other adverse events | Debio 1450 80 mg/120 mg BID | 18 | 110 |
| Total, other adverse events | Debio 1450 160 mg/240 mg BID | 29 | 107 |
| Total, other adverse events | Vancomycin/Linezolid BID | 20 | 107 |
| Total, serious adverse events | Debio 1450 80 mg/120 mg BID | 2 | 110 |
| Total, serious adverse events | Debio 1450 160 mg/240 mg BID | 1 | 107 |
| Total, serious adverse events | Vancomycin/Linezolid BID | 1 | 107 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32747361 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02426918
GET https://conductscience.org/api/trials/v1/NCT02426918/results?page=2