Trial Outcomes & Findings for Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs) (NCT NCT01287832)

NCT ID: NCT01287832

Last Updated: 2014-02-10

Results Overview

Clinical success is the absence of treatment failures. Treatment failures will include death, clinical failure, microbiologic failure, or an adverse event requiring a change in therapy or discontinuation in therapy.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 11 participants
• Primary outcome timeframe: 30-42 days post-treatment
• Results posted on: 2014-02-10

Participant Flow

Participant milestones

Measure	High Dose Vancomycin Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)	High-dose Daptomycin Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
Overall Study STARTED	6	5
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	High Dose Vancomycin Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)	High-dose Daptomycin Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
Overall Study Adverse Event	1	0
Overall Study Death	0	1

Baseline Characteristics

Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs)

Baseline characteristics by cohort

Measure	High Dose Vancomycin n=6 Participants Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)	High-dose Daptomycin n=5 Participants Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)	Total n=11 Participants Total of all reporting groups
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants
Age, Continuous	61.8 years STANDARD_DEVIATION 22.6 • n=5 Participants	68.2 years STANDARD_DEVIATION 10.2 • n=7 Participants	64.7 years STANDARD_DEVIATION 17.5 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30-42 days post-treatment

Clinical success is the absence of treatment failures. Treatment failures will include death, clinical failure, microbiologic failure, or an adverse event requiring a change in therapy or discontinuation in therapy.

Outcome measures

Measure	High Dose Vancomycin n=6 Participants Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)	High-dose Daptomycin n=5 Participants Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
Number of Participants With Clinical Success at Test of Cure Visit.	4 participants	3 participants

SECONDARY outcome

Timeframe: 30-42 days post-treatment

Outcome measures

Outcome data not reported

Adverse Events

High-dose Daptomycin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

High Dose Vancomycin

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	High-dose Daptomycin n=5 participants at risk Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)	High Dose Vancomycin n=6 participants at risk Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
Renal and urinary disorders Nephrotoxicity	0.00% 0/5	16.7% 1/6 • Number of events 1

Other adverse events

Measure	High-dose Daptomycin n=5 participants at risk Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)	High Dose Vancomycin n=6 participants at risk Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
Skin and subcutaneous tissue disorders Rash	20.0% 1/5 • Number of events 1	16.7% 1/6 • Number of events 1
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/5	0.00% 0/6

Additional Information

Leonard Johnson MD

St. John Hospital and Medical Center

Phone: 3133438823

Email: leonard.johnson@stjohn.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place