Trial Outcomes & Findings for Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections (NCT NCT00463801)

Results Overview

Primary objective of the study was to evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the day 7 and day 14 visit (D7, D14) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

52 participants

Primary outcome timeframe

at Day 7 and 14

Results posted on

2011-03-24

Participant Flow

Participant milestones

Participant milestones
Measure	Daptomycin Intravenous 350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
Overall Study STARTED	52
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Daptomycin Intravenous 350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
Overall Study Protocol Violation	1
Overall Study Lack of Efficacy	2
Overall Study Adverse Event	4
Overall Study Lost to Follow-up	5
Overall Study No longer require therapy	1

Baseline Characteristics

Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daptomycin Intravenous n=52 Participants 350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
Age, Customized Age 27-88 years	52 participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: at Day 7 and 14

Population: Intention to treat (ITT) and safety population: all patients who received at least one dose of study medication.

Primary objective of the study was to evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the day 7 and day 14 visit (D7, D14) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.

Outcome measures

Outcome measures
Measure	Daptomycin Intravenous n=52 Participants 350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start	0 Participants

SECONDARY outcome

Timeframe: At day 4, 7, 10 and 14

To evaluate the microbiological efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the proportion of patients achieving eradication of the Gram-positive baseline organisms at the study visits on D4, D7, D10, and D14. Microbiological success is documented eradication of baseline Gram-positive organism or presumed eradication defined as clinical success and no culture performed because of absence of drainage or other material for culture.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At day 4 and 10

To evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the interim visits on day 4 (D4) and day 10 (D10) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At day 14

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At day 14

Time to resolution of signs and symptoms of infection, time to resolution of fever (oral or tympanic temperature ≤37.5°C).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At day 14

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at day 14 and follow up day i.e. day 30

Outcome measures

Outcome data not reported

Adverse Events

All Patients

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Patients n=52 participants at risk All patients
Infections and infestations Cellulitis	1.9% 1/52
Infections and infestations Device related infection	1.9% 1/52
Infections and infestations Soft tissue infection	1.9% 1/52
Injury, poisoning and procedural complications Femur fracture	1.9% 1/52

Other adverse events

Other adverse events
Measure	All Patients n=52 participants at risk All patients
Blood and lymphatic system disorders Anaemia	5.8% 3/52
Investigations Transaminases increased	5.8% 3/52

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER