Trial Outcomes & Findings for Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment (NCT NCT01104662)
NCT ID: NCT01104662
Last Updated: 2018-09-05
Results Overview
The number of participants with CPK elevations of \>500 units per liter (U/L) above baseline at any time from Day 1 through the EOT/ET visit are presented.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
92 participants
Primary outcome timeframe
Baseline through EOT/ET
Results posted on
2018-09-05
Participant Flow
Participant milestones
| Measure |
Daptomycin, Bacteremia, Severe Renal Impairment
Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, Bacteremia, Severe Renal Impairment
Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin/semi-synthetic penicillin (SSP; for example, nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per investigator's discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, Bacteremia, Moderate Renal Impairment
Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, Bacteremia, Moderate Renal Impairment
Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per investigator's discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, cSSSI, Severe Renal Impairment
Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For complicated skin and skin structure infections (cSSSI) participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, cSSSI, Severe Renal Impairment
Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, cSSSI, Moderate Renal Impairment
Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, cSSSI, Moderate Renal Impairment
Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
5
|
4
|
15
|
16
|
5
|
6
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
17
|
17
|
4
|
4
|
15
|
15
|
5
|
6
|
|
Overall Study
COMPLETED
|
10
|
11
|
4
|
3
|
14
|
12
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
1
|
1
|
1
|
4
|
0
|
0
|
Reasons for withdrawal
| Measure |
Daptomycin, Bacteremia, Severe Renal Impairment
Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, Bacteremia, Severe Renal Impairment
Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin/semi-synthetic penicillin (SSP; for example, nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per investigator's discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, Bacteremia, Moderate Renal Impairment
Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, Bacteremia, Moderate Renal Impairment
Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per investigator's discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, cSSSI, Severe Renal Impairment
Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For complicated skin and skin structure infections (cSSSI) participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, cSSSI, Severe Renal Impairment
Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, cSSSI, Moderate Renal Impairment
Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, cSSSI, Moderate Renal Impairment
Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
0
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Clinical Failure
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Participant left investigator's care
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Reason not specified
|
3
|
3
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Randomized but not treated
|
3
|
4
|
1
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment
Baseline characteristics by cohort
| Measure |
Daptomycin, Bacteremia, Severe Renal Impairment
n=17 Participants
Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, Bacteremia, Severe Renal Impairment
n=17 Participants
Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, Bacteremia, Moderate Renal Impairment
n=4 Participants
Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, Bacteremia, Moderate Renal Impairment
n=4 Participants
Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, cSSSI, Severe Renal Impairment
n=15 Participants
Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, cSSSI, Severe Renal Impairment
n=15 Participants
Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, cSSSI, Moderate Renal Impairment
n=5 Participants
Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, cSSSI, Moderate Renal Impairment
n=6 Participants
Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
LTE18
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
BTWN
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
56 Participants
n=6 Participants
|
|
Age, Categorical
GTE65
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
27 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
28 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
55 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline through EOT/ETPopulation: Participants who received at least 1 dose of study drug and had a baseline CPK value and at least 1 post-baseline CPK assessment between Day 1 post-dosing and EOT visit.
The number of participants with CPK elevations of \>500 units per liter (U/L) above baseline at any time from Day 1 through the EOT/ET visit are presented.
Outcome measures
| Measure |
Daptomycin, Bacteremia, Severe Renal Impairment
n=16 Participants
Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, Bacteremia, Severe Renal Impairment
n=14 Participants
Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, Bacteremia, Moderate Renal Impairment
n=3 Participants
Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, Bacteremia, Moderate Renal Impairment
n=4 Participants
Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, cSSSI, Severe Renal Impairment
n=14 Participants
Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, cSSSI, Severe Renal Impairment
n=13 Participants
Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, cSSSI, Moderate Renal Impairment
n=5 Participants
Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, cSSSI, Moderate Renal Impairment
n=4 Participants
Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations Through End of Therapy/Early Termination (EOT/ET)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline through TOC/Safety VisitPopulation: Participants who received at least 1 dose of study drug and had at least 1 Gram-positive baseline infecting pathogen for cSSSI participants or S. aureus bacteremia for bacteremia participants.
Participants were assigned a Sponsor-assessed clinical outcome based on the following definitions at the TOC/Safety visit: Failure: Assessed as a failure at any time by the Investigator or received non-study antimicrobial therapy for lack of efficacy or had the primary site of infection removed completely by surgery or underwent surgery to treat the infection \>4 days after starting study medication. Success: Were not assessed as a failure at any time and were assessed as a cure or improvement by the Investigator at the TOC visit. Non-evaluable: Received potentially effective antimicrobial therapy during the study period for reasons other than lack of efficacy or received \<4 days of study medication or were not assessed by the Investigator.
Outcome measures
| Measure |
Daptomycin, Bacteremia, Severe Renal Impairment
n=15 Participants
Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, Bacteremia, Severe Renal Impairment
n=16 Participants
Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, Bacteremia, Moderate Renal Impairment
n=4 Participants
Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, Bacteremia, Moderate Renal Impairment
n=4 Participants
Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, cSSSI, Severe Renal Impairment
n=15 Participants
Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, cSSSI, Severe Renal Impairment
n=15 Participants
Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, cSSSI, Moderate Renal Impairment
n=5 Participants
Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, cSSSI, Moderate Renal Impairment
n=6 Participants
Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Therapeutic Outcome at Test of Cure (TOC)/Safety Visit
Non-evaluable
|
4 participants
|
6 participants
|
1 participants
|
1 participants
|
2 participants
|
4 participants
|
0 participants
|
0 participants
|
|
Overall Therapeutic Outcome at Test of Cure (TOC)/Safety Visit
Success
|
9 participants
|
9 participants
|
1 participants
|
3 participants
|
10 participants
|
9 participants
|
5 participants
|
4 participants
|
|
Overall Therapeutic Outcome at Test of Cure (TOC)/Safety Visit
Failure
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
3 participants
|
2 participants
|
0 participants
|
2 participants
|
Adverse Events
Daptomycin, Bacteremia, Severe Renal Impairment
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Vancomycin or SSP, Bacteremia, Severe Renal Impairment
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
Daptomycin, Bacteremia, Moderate Renal Impairment
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Vancomycin or SSP, Bacteremia, Moderate Renal Impairment
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Daptomycin, cSSSI, Severe Renal Impairment
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Vancomycin or SSP, cSSSI, Severe Renal Impairment
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Daptomycin, cSSSI, Moderate Renal Impairment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Vancomycin or SSP, cSSSI, Moderate Renal Impairment
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daptomycin, Bacteremia, Severe Renal Impairment
n=17 participants at risk
Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.)
|
Vancomycin or SSP, Bacteremia, Severe Renal Impairment
n=17 participants at risk
Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, Bacteremia, Moderate Renal Impairment
n=4 participants at risk
Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, Bacteremia, Moderate Renal Impairment
n=4 participants at risk
Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, cSSSI, Severe Renal Impairment
n=15 participants at risk
Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, cSSSI, Severe Renal Impairment
n=15 participants at risk
Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, cSSSI, Moderate Renal Impairment
n=5 participants at risk
Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, cSSSI, Moderate Renal Impairment
n=6 participants at risk
Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
Cardiac disorders
Cardiac valve disease
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Cardiac disorders
Cardio-respiratory arrest
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Cardiac disorders
Cardiac failure congestive
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Cardiac disorders
Myocardial infarction
|
11.8%
2/17 • Number of events 2
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Cardiac disorders
Ventricular fibrillation
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/17
|
0.00%
0/17
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Cellulitis
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Endocarditis
|
5.9%
1/17 • Number of events 2
|
11.8%
2/17 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Graft infection
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Sepsis
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Septic shock
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Graft complication
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
Investigations
White blood cell count increased
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/17
|
0.00%
0/17
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/17
|
0.00%
0/17
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Surgical and medical procedures
Thrombolysis
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Vascular disorders
Haematoma
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Vascular disorders
Hypertension
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Vascular disorders
Hypotension
|
0.00%
0/17
|
0.00%
0/17
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
Other adverse events
| Measure |
Daptomycin, Bacteremia, Severe Renal Impairment
n=17 participants at risk
Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.)
|
Vancomycin or SSP, Bacteremia, Severe Renal Impairment
n=17 participants at risk
Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, Bacteremia, Moderate Renal Impairment
n=4 participants at risk
Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, Bacteremia, Moderate Renal Impairment
n=4 participants at risk
Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, cSSSI, Severe Renal Impairment
n=15 participants at risk
Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, cSSSI, Severe Renal Impairment
n=15 participants at risk
Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
Daptomycin, cSSSI, Moderate Renal Impairment
n=5 participants at risk
Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
|
Vancomycin or SSP, cSSSI, Moderate Renal Impairment
n=6 participants at risk
Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator's discretion. All treatments were dosed per Investigator's discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/17
|
0.00%
0/17
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/17
|
5.9%
1/17 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Eye disorders
Eye inflammation
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Eye disorders
Eye pain
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Eye disorders
Vision blurred
|
0.00%
0/17
|
0.00%
0/17
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17
|
11.8%
2/17 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17
|
5.9%
1/17 • Number of events 3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/15
|
13.3%
2/15 • Number of events 2
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Duodenal ulcer
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17
|
23.5%
4/17 • Number of events 5
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 1
|
23.5%
4/17 • Number of events 5
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/17
|
17.6%
3/17 • Number of events 5
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Catheter site oedema
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Chest discomfort
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Chest pain
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Chills
|
0.00%
0/17
|
0.00%
0/17
|
25.0%
1/4 • Number of events 2
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Device leakage
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Fatigue
|
0.00%
0/17
|
0.00%
0/17
|
50.0%
2/4 • Number of events 2
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Infusion site pain
|
0.00%
0/17
|
0.00%
0/17
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Malaise
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Medical device complication
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Oedema
|
0.00%
0/17
|
5.9%
1/17 • Number of events 6
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Oedema peripheral
|
11.8%
2/17 • Number of events 2
|
17.6%
3/17 • Number of events 3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Pyrexia
|
5.9%
1/17 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Tenderness
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Thrombosis in device
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Hepatobiliary disorders
Hepatotoxicity
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Cellulitis
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Chest wall abscess
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Endocarditis
|
11.8%
2/17 • Number of events 2
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Fungal infection
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/17
|
0.00%
0/17
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Localised infection
|
0.00%
0/17
|
0.00%
0/17
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/17
|
0.00%
0/17
|
50.0%
2/4 • Number of events 2
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Septic shock
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17
|
0.00%
0/17
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Blood glucose decreased
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Investigations
Blood glucose increased
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
16.7%
1/6 • Number of events 2
|
|
Investigations
Cardiac murmur
|
11.8%
2/17 • Number of events 2
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Investigations
Haemoglobin decreased
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Investigations
Heart sounds abnormal
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Investigations
International normalised ratio increased
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Investigations
Urine output decreased
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Investigations
White blood cell count increased
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/17
|
0.00%
0/17
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
2/17 • Number of events 3
|
17.6%
3/17 • Number of events 4
|
0.00%
0/4
|
25.0%
1/4 • Number of events 2
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/17
|
17.6%
3/17 • Number of events 3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
1/17 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17
|
11.8%
2/17 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
20.0%
1/5 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/17
|
11.8%
2/17 • Number of events 4
|
25.0%
1/4 • Number of events 2
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/17
|
5.9%
1/17 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Psychiatric disorders
Depression
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
6.7%
1/15 • Number of events 2
|
0.00%
0/5
|
0.00%
0/6
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/17
|
11.8%
2/17 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
1/17 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/17
|
11.8%
2/17 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/17
|
0.00%
0/17
|
25.0%
1/4 • Number of events 2
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17
|
17.6%
3/17 • Number of events 3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/17
|
0.00%
0/17
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin chapped
|
0.00%
0/17
|
0.00%
0/17
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/17
|
0.00%
0/17
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/17
|
0.00%
0/17
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
|
Vascular disorders
Hypotension
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/5
|
0.00%
0/6
|
Additional Information
Vice President, Clinical Research
Cubist Pharmaceuticals, Inc.
Phone: 1.781.860.8660
Results disclosure agreements
- Principal investigator is a sponsor employee The first publication is initiated by Cubist. If first publication not published within 1 year of study conclusion or termination, Investigator has right to publish and disclose the data. Prior to any submission for publication, presentation, or communication of results or information arising from the study, Investigator shall provide Cubist at least 90 days for review and comment upon the manuscript or other material for such publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER