Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Daptomycin 6 mg/kg	Daptomycin (6 mg/kg every 24 hours [q24h]) as a 30 minute intravenous (IV) infusion for 6 weeks (± one week).
Daptomycin 8 mg/kg	Daptomycin (8 mg/kg q24h) as a 30 minute IV infusion for 6 weeks (± one week).
Comparator	Vancomycin was administered at 1 gram (gm)every 12 hours (q12h) as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).

Participant Flow for 2 periods

Period 1:   Completed Study Drug Treatment

	Daptomycin 6 mg/kg	Daptomycin 8 mg/kg	Comparator
STARTED	25	24	26
Received First Dose	25	24	25
COMPLETED	23	18	19
NOT COMPLETED	2	6	7
Adverse Event	2	4	4
Protocol Violation	0	1	1
Withdrawal by Subject	0	1	1
Randomized Not Treated	0	0	1

Period 2:   Completed Test of Cure (TOC) Visit

	Daptomycin 6 mg/kg	Daptomycin 8 mg/kg	Comparator
STARTED	23	18	19
COMPLETED	20	16	17
NOT COMPLETED	3	2	2
Adverse Event	0	1	1
Protocol Violation	0	0	1
Withdrawal by Subject	1	0	0
Lack of Efficacy	2	0	0
Microbiologic failure	0	1	0

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Daptomycin 6 mg/kg	Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
Daptomycin 8 mg/kg	Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
Comparator	Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
Total	Total of all reporting groups

Baseline Measures

	Daptomycin 6 mg/kg	Daptomycin 8 mg/kg	Comparator	Total
Overall Participants Analyzed  [Units: Participants]	25	24	25	74
Age [1]  [Units: Participants]
<=18 years	0	0	0	0
Between 18 and 65 years	10	14	15	39
>=65 years	15	10	10	35
[1] Safety/Intent to Treat Population (1 patient included in the Overall Number of Baseline Participants was randomized to comparator but not treated)
Gender [1]  [Units: Participants]
Female	14	10	11	35
Male	11	14	14	39
[1] Safety/Intent to Treat Population (1 patient included in the Overall Number of Baseline Participants was randomized to comparator but not treated)

1.  Primary:

Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L)   [ Time Frame: From the 3rd day of therapy to 1 week post last dose (approximately week 7) ]

2.  Secondary:

Safety - Notable Laboratory Abnormalities   [ Time Frame: From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30) ]

3.  Secondary:

Overall Clinical Outcome   [ Time Frame: Approximately 6 weeks post last dose (approximately week 12) ]

4.  Secondary:

Microbiological Response   [ Time Frame: Approximately 6 weeks post last dose (approximately week 12) ]

5.  Secondary:

Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax)   [ Time Frame: Day 4 (steady state) ]

6.  Secondary:

Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss)   [ Time Frame: Day 4 (steady state) ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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