Trial Outcomes & Findings for Daptomycin in Treating Neutropenia and Fever in Patients With Cancer (NCT NCT00335478)

Results Overview

If after 72 hours of daptomycin treatment, the patient is afebrile and has absolute neutrophil count (ANC) \>500 cells/mm\^3 for 48 hours with no site of infection, negative cultures, and no clinical indications for therapy, the antibiotic regimen will be discontinued. Complete Response: Resolution of fever and clinical signs/symptoms of infection. Partial Response: Resolution of fever without resolution of clinical signs of infection.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

Within 72 hours of starting daptomycin

Results posted on

2017-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Daptomycin 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is \>500 cells/mm\^3.
Overall Study STARTED	54
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Daptomycin in Treating Neutropenia and Fever in Patients With Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daptomycin n=30 Participants 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is \>500 cells/mm\^3.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	50.4 years STANDARD_DEVIATION 16.730 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 72 hours of starting daptomycin

If after 72 hours of daptomycin treatment, the patient is afebrile and has absolute neutrophil count (ANC) \>500 cells/mm\^3 for 48 hours with no site of infection, negative cultures, and no clinical indications for therapy, the antibiotic regimen will be discontinued. Complete Response: Resolution of fever and clinical signs/symptoms of infection. Partial Response: Resolution of fever without resolution of clinical signs of infection.

Outcome measures

Outcome measures
Measure	Daptomycin n=30 Participants 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is \>500 cells/mm\^3.
Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.	16 participants

Adverse Events

Daptomycin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joseph Bubalo, PharmD, BCPS, BCOP

OHSU Knight Cancer Institute

Phone: 503-494-1080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place