Trial · NCT02276482
Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012)
NCT02276482, Phase 3, Completed, Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2019-08-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012). Trials, record NCT02276482. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02276482
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012)
- NCT number
- NCT02276482
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 120 participants, actual
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Skin Diseases, Infectious, Skin Diseases, Bacterial
- Interventions
- Tedizolid Phophate, Antibiotic comparator, Aztreonam, Metronidazole
- First posted
- 2014-10-28
- Last updated
- 2019-08-07
- Other registries' IDs
- eudract:2014-004023-40
- Results first posted
- 2019-08-07
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events on Tedizolid Phosphate and Comparator Drugs | Up to 40 days (including 30-day follow-up) | An adverse event (AE) refers to a treatment-emergent adverse event (TE-AE). A TE-AE is any AE that newly appeared, increased in frequency, or worsened in severity following initiation of study drug. |
| Secondary | Number of Participants With Investigator's Assessment Indicating Clinical Success at Test of Cure (TOC) Visit (Intent to Treat Analysis Set) | TOC Visit: 18-25 days after first drug infusion | Investigator's assessment of clinical success is defined as (1) resolution or near resolution of most disease-specific signs and symptoms, (2)absence or near resolution of regional or systemic signs of infection (lymphadenopathy, fever, \>10% immature neutrophils, abnormal white blood cell count), if present at baseline, and (3) no new signs, symptoms, or complications attributable to the infection under study so no further antibiotic therapy is required for the treatment of the primary lesion. |
| Secondary | Number of Participants With Investigator's Assessment Indicating Clinical Success at TOC Visit (Clinically Evaluable-Test of Cure [CE-TOC] Analysis Set) | TOC Visit: 18-25 days after first drug infusion | Investigator's assessment of clinical success is defined as (1) resolution or near resolution of most disease-specific signs and symptoms, (2)absence or near resolution of regional or systemic signs of infection (lymphadenopathy, fever, \>10% immature neutrophils, abnormal white blood cell count), if present at baseline, and (3) no new signs, symptoms, or complications attributable to the infection under study so no further antibiotic therapy is required for the treatment of the primary lesion. |
| Secondary | Number of Participants With Early Clinical Responses Measured by Lesion Reduction | 48-72 hr after first drug infusion | Early clinical response is defined as ≥20% reduction from baseline lesion area (defined as length multiplied by the width of the erythema, edema, and/or induration \[EEI\]) at the 48-72 hour (hr) visit. |
| Secondary | Number of Participants With Investigator's Assessment Indicating Clinical Success at End of Therapy (EOT) Visit (Intent to Treat Analysis Set) | EOT Visit: up to 13 days after first drug infusion | Investigator's assessment of clinical success is defined as (1) resolution or near resolution of most disease-specific signs and symptoms, (2)absence or near resolution of regional or systemic signs of infection (lymphadenopathy, fever, \>10% immature neutrophils, abnormal white blood cell count), if present at baseline, and (3) no new signs, symptoms, or complications attributable to the infection under study so no further antibiotic therapy is required for the treatment of the primary lesion. |
| Secondary | Number of Participants With Investigator's Assessment Indicating Clinical Success at EOT Visit (Clinically Evaluable-End of Therapy [CE-EOT] Analysis Set) | EOT Visit: up to 13 days after first drug infusion | Investigator's assessment of clinical success is defined as (1) resolution or near resolution of most disease-specific signs and symptoms, (2) absence or near resolution of regional or systemic signs of infection (lymphadenopathy, fever, \>10% immature neutrophils, abnormal white blood cell count), if present at baseline, and (3) no new signs, symptoms, or complications attributable to the infection under study so no further antibiotic therapy is required for the treatment of the primary lesion. |
| Other | Change From Baseline in Lesion Size | Baseline and TOC visit (18 to 25 days after infusion) | Lesion size is the area in cm\^2 of erythema, edema or induration. A negative number corresponds to a decrease in lesion size. |
| Other | Peak Plasma Concentration (Cmax) of Tedizolid | Day 1 at 5-80 minutes (min) and 4-12 hrs post-infusion or 2 samples collected between 4-12 hrs after oral dose, at least 60 min apart; at 48-72 hrs: within 60 min prior to administration and 4-12 hrs after administration; and anytime between Day 7 and 9 | The Cmax of tedizolid in plasma after the last dose was estimated based on population pharmacokinetic analysis of observed pharmacokinetic data. Blood samples were collected for pharmacokinetic analysis at specific time points. |
| Other | Area Under the Plasma Concentration Versus Time Curve Time 0 to 24 Hours (AUC0-24h) of Tedizolid | Day 1 at 5-80 min and 4-12 hrs post-infusion or 2 samples collected between 4-12 hrs after oral dose, at least 60 min apart; at 48-72 hrs: within 60 min prior to administration and 4-12 hrs after administration; and anytime between Day 7 and 9 | AUC0-24h is a measure of the total tedizolid exposure in the plasma from the dose to 24 hours after last dose. AUC0-24h was estimated based on population pharmacokinetic analysis of observed pharmacokinetic data. Blood samples were collected for pharmacokinetic analysis at specific time points. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events on Tedizolid Phosphate and Comparator Drugs | Up to 40 days (including 30-day follow-up) | All randomized participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Investigator's Assessment Indicating Clinical Success at Test of Cure (TOC) Visit (Intent to Treat Analysis Set) | TOC Visit: 18-25 days after first drug infusion | All randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Investigator's Assessment Indicating Clinical Success at TOC Visit (Clinically Evaluable-Test of Cure [CE-TOC] Analysis Set) | TOC Visit: 18-25 days after first drug infusion | All randomized participants who received a full dose of study treatment and completed TOC. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Early Clinical Responses Measured by Lesion Reduction | 48-72 hr after first drug infusion | All randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Investigator's Assessment Indicating Clinical Success at End of Therapy (EOT) Visit (Intent to Treat Analysis Set) | EOT Visit: up to 13 days after first drug infusion | All randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Investigator's Assessment Indicating Clinical Success at EOT Visit (Clinically Evaluable-End of Therapy [CE-EOT] Analysis Set) | EOT Visit: up to 13 days after first drug infusion | All randomized participants received a full dose of study treatment and completed EOT. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change From Baseline in Lesion Size | Baseline and TOC visit (18 to 25 days after infusion) | All randomized participants who received a full dose of study treatment, had a baseline value and a TOC visit value (Days 18 to 25). | cm^2 | MEAN |
| OTHER_PRE_SPECIFIED | Peak Plasma Concentration (Cmax) of Tedizolid | Day 1 at 5-80 minutes (min) and 4-12 hrs post-infusion or 2 samples collected between 4-12 hrs after oral dose, at least 60 min apart; at 48-72 hrs: within 60 min prior to administration and 4-12 hrs after administration; and anytime between Day 7 and 9 | All randomized participants who received a dose of tedizolid phosphate. Pharmacokinetic analysis was not performed with participants receiving antibiotic comparator drug. | µg/mL | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Area Under the Plasma Concentration Versus Time Curve Time 0 to 24 Hours (AUC0-24h) of Tedizolid | Day 1 at 5-80 min and 4-12 hrs post-infusion or 2 samples collected between 4-12 hrs after oral dose, at least 60 min apart; at 48-72 hrs: within 60 min prior to administration and 4-12 hrs after administration; and anytime between Day 7 and 9 | All randomized participants who received a dose of tedizolid phosphate. Pharmacokinetic analysis was not performed with participants receiving antibiotic comparator drug. | µg*h/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events on Tedizolid Phosphate and Comparator Drugs | Tedizolid Phosphate | 13 | Participants | ||
| Number of Participants With Adverse Events on Tedizolid Phosphate and Comparator Drugs | Antibiotic Comparator Drug | 3 | Participants | ||
| Number of Participants With Investigator's Assessment Indicating Clinical Success at Test of Cure (TOC) Visit (Intent to Treat Analysis Set) | Tedizolid Phosphate | 88 | Participants | ||
| Number of Participants With Investigator's Assessment Indicating Clinical Success at Test of Cure (TOC) Visit (Intent to Treat Analysis Set) | Antibiotic Comparator Drug | 27 | Participants | ||
| Number of Participants With Investigator's Assessment Indicating Clinical Success at TOC Visit (Clinically Evaluable-Test of Cure [CE-TOC] Analysis Set) | Tedizolid Phosphate | 87 | Participants | ||
| Number of Participants With Investigator's Assessment Indicating Clinical Success at TOC Visit (Clinically Evaluable-Test of Cure [CE-TOC] Analysis Set) | Antibiotic Comparator Drug | 26 | Participants | ||
| Number of Participants With Early Clinical Responses Measured by Lesion Reduction | Tedizolid Phosphate | 84 | Participants | ||
| Number of Participants With Early Clinical Responses Measured by Lesion Reduction | Antibiotic Comparator Drug | 28 | Participants | ||
| Number of Participants With Investigator's Assessment Indicating Clinical Success at End of Therapy (EOT) Visit (Intent to Treat Analysis Set) | Tedizolid Phosphate | 88 | Participants | ||
| Number of Participants With Investigator's Assessment Indicating Clinical Success at End of Therapy (EOT) Visit (Intent to Treat Analysis Set) | Antibiotic Comparator Drug | 28 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tedizolid Phosphate | 91 | |
| Overall Study | STARTED | Antibiotic Comparator Drug | 29 | |
| Overall Study | COMPLETED | Tedizolid Phosphate | 88 | |
| Overall Study | COMPLETED | Antibiotic Comparator Drug | 28 | |
| Overall Study | NOT COMPLETED | Tedizolid Phosphate | 3 | |
| Overall Study | NOT COMPLETED | Antibiotic Comparator Drug | 1 |
Source ClinicalTrials.gov
Adverse events6
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 |
|---|---|---|---|---|---|---|
| serious | Pneumonia | Infections and infestations | Tedizolid Phosphate | 1 | 91 | 1 |
| serious | Pneumonia | Infections and infestations | Antibiotic Comparator Drug | 0 | 29 | 0 |
| serious | Sepsis | Infections and infestations | Tedizolid Phosphate | 1 | 91 | 1 |
| serious | Sepsis | Infections and infestations | Antibiotic Comparator Drug | 0 | 29 | 0 |
| serious | Venous Thrombosis Limb | Vascular disorders | Tedizolid Phosphate | 1 | 91 | 1 |
| serious | Venous Thrombosis Limb | Vascular disorders | Antibiotic Comparator Drug | 0 | 29 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tedizolid Phosphate | 0 | 91 |
| Total, all-cause mortality | Antibiotic Comparator Drug | 0 | 29 |
| Total, other adverse events | Tedizolid Phosphate | 0 | 91 |
| Total, other adverse events | Antibiotic Comparator Drug | 0 | 29 |
| Total, serious adverse events | Tedizolid Phosphate | 1 | 91 |
| Total, serious adverse events | Antibiotic Comparator Drug | 0 | 29 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33395210 | 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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tedizolid Phosphate vs Antibiotic Comparator Drug: Number of Participants With Investigator's Assessment Indicating Clinical Success at Test of Cure (TOC) Visit (Intent to Treat Analysis Set) | Trial comparisons |
Tedizolid Phosphate vs Antibiotic Comparator Drug: Number of Participants With Investigator's Assessment Indicating Clinical Success at EOT Visit (Clinically Evaluable-End of Therapy [CE-EOT] Analysis Set) | Trial comparisons |
| Tedizolid Phosphate vs Antibiotic Comparator Drug: Number of Participants With Investigator's Assessment Indicating Clinical Success at End of Therapy (EOT) Visit (Intent to Treat Analysis Set) | Trial comparisons |
Tedizolid Phosphate vs Antibiotic Comparator Drug: Number of Participants With Investigator's Assessment Indicating Clinical Success at TOC Visit (Clinically Evaluable-Test of Cure [CE-TOC] Analysis Set) | Trial comparisons |
| Tedizolid Phosphate vs Antibiotic Comparator Drug: Number of Participants With Early Clinical Responses Measured by Lesion Reduction | Trial comparisons |
| Tedizolid Phosphate vs Antibiotic Comparator Drug: Number of Participants With Adverse Events on Tedizolid Phosphate and Comparator Drugs | Trial comparisons |
| Tedizolid Phosphate vs Antibiotic Comparator Drug: deaths from any cause | Trial comparisons |
| Tedizolid Phosphate vs Antibiotic Comparator Drug: serious adverse events | Trial comparisons |
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.
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Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT02276482/registered