Trial · NCT00428844
Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci
NCT00428844, Phase 2, Completed, Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2011-06-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci. Trials, record NCT00428844. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00428844
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci
- NCT number
- NCT00428844
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 75 participants, actual
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Osteomyelitis
- Interventions
- daptomycin, daptomycin, vancomycin, teicoplanin, nafcillin, oxacillin, flucloxacillin
- First posted
- 2007-01-30
- Last updated
- 2018-01-31
- Results first posted
- 2011-06-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L) | From the 3rd day of therapy to 1 week post last dose (approximately week 7) | Number of subjects with CPK \>500 U/L between Day 3 and 7 days following the last dose of study medication (Day 7P) as measured by the central laboratory. |
| Secondary | Safety - Notable Laboratory Abnormalities | From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30) | Summary of Notable Laboratory Abnormalities - description of the proportion of subjects within each treatment group that had clinical laboratory values outside the reference range. |
| Secondary | Overall Clinical Outcome | Approximately 6 weeks post last dose (approximately week 12) | The sponsor determined overall clinical outcome based on blinded review of clinical, microbiological, and radiological response of the subject including, but not limited to, clinical signs and symptoms of PJI, microbiological assessments, radiographic findings, and surgical procedures performed. Subjects were a success if both clinical and microbiological responses were success. A subject who failed to respond clinically or microbiologically was a failure. If microbiological response was non-evaluable and/or clinical evaluation at TOC was not performed, the subject was non-evaluable. |
| Secondary | Microbiological Response | Approximately 6 weeks post last dose (approximately week 12) | Sponsor's assessment of subject-level microbiological response at the test-of-cure visit for the modified Intent-to-Treat (mITT) population. |
| Secondary | Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) | Day 4 (steady state) | The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion. |
| Secondary | Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss) | Day 4 (steady state) | The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L) | From the 3rd day of therapy to 1 week post last dose (approximately week 7) | Safety Population | Participants | NUMBER |
| SECONDARY | Safety - Notable Laboratory Abnormalities | From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30) | Safety Population | Participants | NUMBER |
| SECONDARY | Overall Clinical Outcome | Approximately 6 weeks post last dose (approximately week 12) | Modified Intent-to-Treat Population. Six treated patients in the ITT population were not included in the mITT population, as they did not have confirmed baseline staphylococcal infection. | Participants | NUMBER |
| SECONDARY | Microbiological Response | Approximately 6 weeks post last dose (approximately week 12) | Modified Intent to Treat Population. Six treated patients in the ITT population were not included in the mITT population, as they did not have confirmed baseline staphylococcal infection. | Participants | NUMBER |
| SECONDARY | Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) | Day 4 (steady state) | Pharmacokinetic evaluable population. Pharmacokinetics not analyzed for the comparator group. | µg/mL | MEDIAN |
| SECONDARY | Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss) | Day 4 (steady state) | Pharmacokinetic evaluable population. Pharmacokinetics not analyzed for the comparator group. | µg•hr/mL | MEDIAN |
Source ClinicalTrials.gov
Results by group61
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L) | Daptomycin 6 mg/kg | 4 | Participants | ||
| Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L) | Daptomycin 8 mg/kg | 5 | Participants | ||
| Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L) | Comparator | 2 | Participants | ||
| Safety - Notable Laboratory Abnormalities | Daptomycin 6 mg/kg | Hematocrit (<30%, >60%) | 12 | Participants | |
| Safety - Notable Laboratory Abnormalities | Daptomycin 8 mg/kg | Hematocrit (<30%, >60%) | 10 | Participants | |
| Safety - Notable Laboratory Abnormalities | Comparator | Hematocrit (<30%, >60%) | 15 | Participants | |
| Safety - Notable Laboratory Abnormalities | Daptomycin 6 mg/kg | Hemoglobin (<9,>19 g/dL) | 10 | Participants | |
| Safety - Notable Laboratory Abnormalities | Daptomycin 8 mg/kg | Hemoglobin (<9,>19 g/dL) | 10 | Participants | |
| Safety - Notable Laboratory Abnormalities | Comparator | Hemoglobin (<9,>19 g/dL) | 12 | Participants | |
| Safety - Notable Laboratory Abnormalities | Daptomycin 6 mg/kg | Red Blood Cell (Female <2.5,>6.0; Male <3.0, >6.5) | 2 | Participants |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Completed Study Drug Treatment | STARTED | Daptomycin 6 mg/kg | 25 | |
| Completed Study Drug Treatment | STARTED | Daptomycin 8 mg/kg | 24 | |
| Completed Study Drug Treatment | STARTED | Comparator | 26 | |
| Completed Study Drug Treatment | Received First Dose | Daptomycin 6 mg/kg | 25 | |
| Completed Study Drug Treatment | Received First Dose | Daptomycin 8 mg/kg | 24 | |
| Completed Study Drug Treatment | Received First Dose | Comparator | 25 | |
| Completed Study Drug Treatment | COMPLETED | Daptomycin 6 mg/kg | 23 | |
| Completed Study Drug Treatment | COMPLETED | Daptomycin 8 mg/kg | 18 | |
| Completed Study Drug Treatment | COMPLETED | Comparator | 19 | |
| Completed Study Drug Treatment | NOT COMPLETED | Daptomycin 6 mg/kg | 2 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events189
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 | Vision blurred | Eye disorders | Daptomycin 6 mg/kg | 0 | 25 | 0 |
| other | Vision blurred | Eye disorders | Daptomycin 8 mg/kg | 0 | 24 | 0 |
| other | Vision blurred | Eye disorders | Comparator | 2 | 25 | 2 |
| other | Constipation | Gastrointestinal disorders | Daptomycin 6 mg/kg | 4 | 25 | 5 |
| other | Constipation | Gastrointestinal disorders | Daptomycin 8 mg/kg | 2 | 24 | 2 |
| other | Constipation | Gastrointestinal disorders | Comparator | 1 | 25 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Daptomycin 6 mg/kg | 2 | 25 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Daptomycin 8 mg/kg | 2 | 24 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Comparator | 2 | 25 | 3 |
| other | Dyspepsia | Gastrointestinal disorders | Daptomycin 6 mg/kg | 0 | 25 | 0 |
1 to 10 of 189Source ClinicalTrials.gov
See all 189 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daptomycin 6 mg/kg | ||
| Total, all-cause mortality | Daptomycin 8 mg/kg | ||
| Total, all-cause mortality | Comparator | ||
| Total, other adverse events | Daptomycin 6 mg/kg | 23 | 25 |
| Total, other adverse events | Daptomycin 8 mg/kg | 18 | 24 |
| Total, other adverse events | Comparator | 22 | 25 |
| Total, serious adverse events | Daptomycin 6 mg/kg | 8 | 25 |
| Total, serious adverse events | Daptomycin 8 mg/kg | 4 | 24 |
| Total, serious adverse events | Comparator | 8 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22908174 | 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/NCT00428844
GET https://conductscience.org/api/trials/v1/NCT00428844/results?page=2