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Trial Outcomes & Findings for Home Away From Home - Medical Outcomes (NCT NCT02774850)

NCT ID: NCT02774850

Last Updated: 2019-12-23

Results Overview

Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC \> 200 uL), or until the start of the next course (for a very small number of patients who begin the next course of chemotherapy prior to count recovery). Bacteremia will be defined as a single positive blood culture for a bacterial pathogen (including Viridans group Streptococci). If the bacterium is an organism considered as a common commensal organism by the National Healthcare Safety Network, two separate positive blood cultures will be required for classification as bacteremia.

Recruitment status

COMPLETED

Target enrollment

610 participants

Primary outcome timeframe

Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC > 200 uL), or until the start of the next course.

Results posted on

2019-12-23

Participant Flow

610 patients reflects the total number of patients included in chart abstractions; from there exclusion criteria were applied to determine early discharge eligibility. They were assigned to Early Discharge Management and Inpatient Management by chemotherapy course, not by the overall treatment.

Participant milestones

Participant milestones
Measure
Pediatric AML Patients
All patients included in chart abstractions. Exclusion criteria were applied to these patients to determine if they were early discharge eligible. Then they were assigned to outpatient-managed and inpatient-managed arms.
Overall Study
STARTED
610
Overall Study
Induction I
585
Overall Study
Early Discharge Eligible at Induction I
276
Overall Study
Induction II
564
Overall Study
Early Discharge Eligible at Induction II
493
Overall Study
Intensification I
476
Overall Study
Early Discharge Eligible at Int I
374
Overall Study
Intensification II
342
Overall Study
Early Discharge Eligible at Int II
285
Overall Study
Intensification III
48
Overall Study
Early Discharge Eligible at Int III
44
Overall Study
COMPLETED
575
Overall Study
NOT COMPLETED
35

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Home Away From Home - Medical Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Early Discharge Management
n=114 Participants
Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course
Inpatient Management
n=379 Participants
Remain hospitalized during chemotherapy-induced neutropenia
Total
n=493 Participants
Total of all reporting groups
Age, Categorical
<=18 years
114 Participants
n=5 Participants
379 Participants
n=7 Participants
493 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
53 Participants
n=5 Participants
192 Participants
n=7 Participants
245 Participants
n=5 Participants
Sex: Female, Male
Male
61 Participants
n=5 Participants
187 Participants
n=7 Participants
248 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · White
52 Participants
n=5 Participants
224 Participants
n=7 Participants
276 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · Black
17 Participants
n=5 Participants
74 Participants
n=7 Participants
91 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · Asian
11 Participants
n=5 Participants
26 Participants
n=7 Participants
37 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · Other
33 Participants
n=5 Participants
44 Participants
n=7 Participants
77 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · Not recorded in EMR
1 Participants
n=5 Participants
11 Participants
n=7 Participants
12 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic Ethnicity · Hispanic Ethnicity
29 Participants
n=5 Participants
77 Participants
n=7 Participants
106 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic Ethnicity · Not Hispanic Ethnicity
85 Participants
n=5 Participants
302 Participants
n=7 Participants
387 Participants
n=5 Participants
Region of Enrollment
United States
114 participants
n=5 Participants
379 participants
n=7 Participants
493 participants
n=5 Participants

PRIMARY outcome

Timeframe: Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC > 200 uL), or until the start of the next course.

Population: Patients in study course Induction II analyzed for bacteremia for this course.

Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC \> 200 uL), or until the start of the next course (for a very small number of patients who begin the next course of chemotherapy prior to count recovery). Bacteremia will be defined as a single positive blood culture for a bacterial pathogen (including Viridans group Streptococci). If the bacterium is an organism considered as a common commensal organism by the National Healthcare Safety Network, two separate positive blood cultures will be required for classification as bacteremia.

Outcome measures

Outcome measures
Measure
Early Discharge Management
n=114 Participants
Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course
Inpatient Management
n=379 Participants
Remain hospitalized during chemotherapy-induced neutropenia
Occurrence of Post-chemotherapy Bacteremia
22 Participants
81 Participants

SECONDARY outcome

Timeframe: The number of days from the three days after the completion chemotherapy in a given course until the first day of the next course

Population: Patients in Induction II who were analyzed for the amount of time (in days) it took for them to start their next chemotherapy course.

Time to next course of chemotherapy will be measured as the number of days from the three days after the completion chemotherapy in a given course until the first day of the next course.

Outcome measures

Outcome measures
Measure
Early Discharge Management
n=114 Participants
Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course
Inpatient Management
n=379 Participants
Remain hospitalized during chemotherapy-induced neutropenia
Time to the Initiation of the Next Chemotherapy Course
31.5 days
Standard Deviation 9.4
27.8 days
Standard Deviation 7.6

Adverse Events

Early Discharge Management

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Inpatient Management

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

Dr. Richard Aplenc

Children's Hospital of Philadelphia

Phone: 267-426-7252

Results disclosure agreements

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