Trial · NCT01922011
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Clinical Improvement in the 3 General Categories of Pain, Inflammation, and Limb Function Based on the Investigator's Overall Assessment of Severity of Each of the Symptom Categories. | Up to study Day 5 | All randomized participants who received any amount of IV study drug and who had a confirmed or suspected diagnosis of AHO, excluding those with confirmed culture of a gram-negative organism from any baseline specimen. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Improvement Measured as a Composite End Point of Pain, Inflammation, Limb Function, Body Temperature, and C-reactive Protein at End-of IV (EOIV) Therapy Visit. | Up to study Day 5 | All randomized participants who received any amount of IV study drug and who had a confirmed diagnosis of AHO (Categories I, II and III), excluding participants with confirmed culture of a gram-negative organism from any baseline specimen and who did not have all clinical assessments performed at the time point. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Favorable Clinical Outcome | Baseline (within 48 hours prior to first dose of IV study drug) - and up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77) | All randomized participants who received any amount of IV study drug and who had a confirmed diagnosis of AHO (Categories I, II and III), excluding participants with confirmed culture of a gram-negative organism from any baseline specimen | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Clinical Cure Categorized by Baseline Pathogen at Test of Cure | Baseline (within 48 hours prior to first dose of IV study drug) - and Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77) | All randomized participants who received IV study drug and had a confirmed diagnosis of AHO, excluding participants with confirmed culture of a gram-negative organism; but including those where at least one bacterial pathogen was isolated from an appropriate microbiological specimen at baseline. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Clinical Improvement | Baseline (within 48 hours prior to first dose of IV study drug) - up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77) | All randomized participants who received any amount of IV study drug and who had a confirmed or suspected diagnosis of AHO, excluding those with confirmed culture of a gram-negative organism from any baseline specimen; and had non-missing clinical outcome. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Favorable Microbiological Response Categorized by Baseline Pathogen at Test of Cure | Baseline (within 48 hours prior to first dose of IV study drug) - and Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77) | All randomized participants who received IV study drug and had a confirmed diagnosis of AHO, excluding participants with confirmed culture of a gram-negative organism; but including those where at least one bacterial pathogen was isolated from an appropriate microbiological specimen at baseline. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With 1 or More Adverse Events (AEs) | Administration of first dose up to approximately six and a half months after last dose of study drug | Treated participants based on the treatment received | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With 1 or More Serious Adverse Events (SAEs) | Administration of first dose through the last follow-up visit; an expected time of up to 6.5 months | Treated participants based on the treatment received | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Concentration of Serum Creatine Kinase (CK) | Baseline and End of Therapy IV (up to Day 42) | Treated participants based on the treatment received | U/L | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments | Baseline and up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77) | Data were only summarized for each visit; but not analyzed. | ||
| OTHER_PRE_SPECIFIED | Plasma Concentration of Daptomycin at the End of IV Infusion | Day 3 up to Day 42 | Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed. | µg/mL | MEAN |
| OTHER_PRE_SPECIFIED | Plasma Concentration of Daptomycin at 15 Minutes to 1 Hour After the End of IV Infusion | Day 3 up to Day 42 | Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed. | µg/mL | MEAN |
| OTHER_PRE_SPECIFIED | Plasma Concentration of Daptomycin at 2 to 3 Hours After the End of IV Infusion | Day 3 up to Day 42 | Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed. | µg/mL | MEAN |
| OTHER_PRE_SPECIFIED | Plasma Concentration of Daptomycin at 4 to 5 Hours After the End of IV Infusion | Day 3 up to Day 42 | Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed. | µg/mL | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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