Trial Outcomes & Findings for Catheter Related - Gram Positive Bloodstream Infections (NCT NCT00467272)

Results Overview

Number of participants with clinical response within 48 hours from initiation of Daptomycin, estimated by Bayesian posterior credible interval. Clinical response defined as resolution of clinical signs and symptoms within 48 hours from initiating the study drug.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Within 48 hours from initiating the study drug

Results posted on

2021-02-08

Participant Flow

Recruitment Period: June 2006 to March 2008. All recruitment done at UT MD Anderson Cancer Center.

This study is the continuation of trial NCT00507247 which included 11 participants; the results has been combined NCT00507247 and NCT00467272. A total of combined participants were 41, out of which 38 participants were included in the analysis and 3 participants were excluded.

Participant milestones

Participant milestones
Measure	Daptomycin 6 mg/kg IV Daptomycin: 6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for Staphylococcus aureus (SA) and at least 7 days for enterococci and Coagulase Negative Staphylococci (CNS), Corynebacterium and Propionibacterium.
Overall Study STARTED	41
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Daptomycin 6 mg/kg IV Daptomycin: 6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for Staphylococcus aureus (SA) and at least 7 days for enterococci and Coagulase Negative Staphylococci (CNS), Corynebacterium and Propionibacterium.
Overall Study Pneumonia	2
Overall Study Thrombophlebitis	1

Baseline Characteristics

Catheter Related - Gram Positive Bloodstream Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daptomycin 6 mg/kg IV n=38 Participants Daptomycin: 6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for Staphylococcus aureus (SA) and at least 7 days for enterococci and Coagulase Negative Staphylococci (CNS), Corynebacterium and Propionibacterium.
Age, Continuous	53 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 48 hours from initiating the study drug

Population: Of the 38 participants analyzed, one participant was excluded from the analyses because the date of symptom resolution was missing.

Number of participants with clinical response within 48 hours from initiation of Daptomycin, estimated by Bayesian posterior credible interval. Clinical response defined as resolution of clinical signs and symptoms within 48 hours from initiating the study drug.

Outcome measures

Outcome measures
Measure	Daptomycin 6 mg/kg IV n=37 Participants Daptomycin: 6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for Staphylococcus aureus (SA) and at least 7 days for enterococci and Coagulase Negative Staphylococci (CNS), Corynebacterium and Propionibacterium.
Clinical Response Within 48 Hours	28 Participants

PRIMARY outcome

Timeframe: Within 7 days from initiating the study drug

Population: Of the 38 participants analyzed, one participant was excluded from the analyses because the date of symptom resolution was missing.

Number of participants with clinical response within 1 week from initiation of Daptomycin, estimated by Bayesian posterior credible interval. Clinical response defined as resolution of clinical signs and symptoms within 7 days from initiating the study drug.

Outcome measures

Outcome measures
Measure	Daptomycin 6 mg/kg IV n=37 Participants Daptomycin: 6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for Staphylococcus aureus (SA) and at least 7 days for enterococci and Coagulase Negative Staphylococci (CNS), Corynebacterium and Propionibacterium.
Clinical Response Within 7 Days	33 Participants

PRIMARY outcome

Timeframe: Within 48 hours from initiating the study drug

Population: Of the 38 participants analyzed, one participant was excluded from the analyses because the date of microbiological eradication was unknown.

Number of participants with microbiological response within 48 hours from initiation of Daptomycin. Microbiological response defined as eradication of the microorganism from the bloodstream (negative blood cultures).

Outcome measures

Outcome measures
Measure	Daptomycin 6 mg/kg IV n=37 Participants Daptomycin: 6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for Staphylococcus aureus (SA) and at least 7 days for enterococci and Coagulase Negative Staphylococci (CNS), Corynebacterium and Propionibacterium.
Microbiological Response Within 48 Hours	29 Participants

PRIMARY outcome

Timeframe: Within 7 days from initiating the study drug

Population: Of the 38 participants analyzed, one participant was excluded from the analyses because the date of microbiological eradication was unknown.

Number of participants with microbiological response within 7 days from initiation of Daptomycin. Microbiological response defined as eradication of the microorganism from the bloodstream (negative blood cultures).

Outcome measures

Outcome measures
Measure	Daptomycin 6 mg/kg IV n=37 Participants Daptomycin: 6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for Staphylococcus aureus (SA) and at least 7 days for enterococci and Coagulase Negative Staphylococci (CNS), Corynebacterium and Propionibacterium.
Microbiological Response Within 7 Days	34 Participants

SECONDARY outcome

Timeframe: Within 3 months from initiating the study drug

Population: Of the 38 participants analyzed, one participant was excluded from the analyses because of microbiological failure.

Number of participants with relapse was defined as the recurrence of bacteremia within the first 3 months.

Outcome measures

Outcome measures
Measure	Daptomycin 6 mg/kg IV n=37 Participants Daptomycin: 6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for Staphylococcus aureus (SA) and at least 7 days for enterococci and Coagulase Negative Staphylococci (CNS), Corynebacterium and Propionibacterium.
Relapse	3 Participants

SECONDARY outcome

Timeframe: Within 3 days from initiating the study drug

Population: Of the 38 participants analyzed, one participant was excluded from the analyses because the date of symptom resolution was unknown.

Overall response = symptom resolution within 3 days (since using antibiotic) + microbiological resolution within 3 days + no infection-related death + no infection-related late complications + no relapse. Infection-related late complication was defined as the development of deep-seated infection that was not present or suspected at the onset of bacteremia but was subsequently diagnosed after 1 week from initiation of study drug.

Outcome measures

Outcome measures
Measure	Daptomycin 6 mg/kg IV n=37 Participants Daptomycin: 6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for Staphylococcus aureus (SA) and at least 7 days for enterococci and Coagulase Negative Staphylococci (CNS), Corynebacterium and Propionibacterium.
Number of Participants With Overall Response	25 Participants

Adverse Events

Daptomycin 6 mg/kg IV

Serious events: 18 serious events

Other events: 18 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Daptomycin 6 mg/kg IV n=38 participants at risk Daptomycin: 6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for Staphylococcus aureus (SA) and at least 7 days for enterococci and Coagulase Negative Staphylococci (CNS), Corynebacterium and Propionibacterium.
Metabolism and nutrition disorders Increased Creatinine kinase	47.4% 18/38 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit, up to 2 years
Skin and subcutaneous tissue disorders Rash	47.4% 18/38 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit, up to 2 years

Other adverse events

Other adverse events
Measure	Daptomycin 6 mg/kg IV n=38 participants at risk Daptomycin: 6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for Staphylococcus aureus (SA) and at least 7 days for enterococci and Coagulase Negative Staphylococci (CNS), Corynebacterium and Propionibacterium.
Nervous system disorders Confusion	47.4% 18/38 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit, up to 2 years

Additional Information

Issam Raad, MD / Chair, Infectious Diseases

University of Texas (UT) MD Anderson Cancer Center

Phone: 713-792-7943

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place