NCT01450241

Brief Summary

The purpose of this study is to determine whether short-course antibiotic therapy is safe and effective for the treatment of cancer patients with febrile neutropenia.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2011

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 12, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 7, 2013

Status Verified

June 1, 2013

Enrollment Period

2 years

First QC Date

September 17, 2011

Last Update Submit

June 6, 2013

Conditions

Febrile Neutropenia

Keywords

Febrile neutropeniaUnexplained feverDurationShort-term antibiotic treatment

Outcome Measures

Primary Outcomes (2)

  • Composite outcome of all-cause mortality, severe infection, severe diarrhea or fever

    Composite outcome of all-cause mortality, severe infection (defined as clinically or microbiologically documented infection with systemic inflammatory response syndrome (SIRS)), severe diarrhea (\>=3 daily for \>=2 days) or fever (\>38)

    After day 7 from randomization until day 30

  • Total febrile or antibiotic days

    Total febrile or antibiotic days from the day of randomization until day 30, defined as a day with one or more temperature measurement \>38.0°C or a day on which antibiotic treatment was prescribed for any reason other than prophylaxis

    From the day of randomization until day 30

Secondary Outcomes (10)

  • Clinically and/or microbiologically documented infections

    30 days

  • Total in-hospital days

    30 days

  • Re-admission

    30 days

  • Antibiotic treatment

    After day 7 from randomization until day 30

  • Antifungal treatment

    30 days

  • +5 more secondary outcomes

Study Arms (2)

Early antibiotic discontinuation

EXPERIMENTAL

Antibiotic treatment stopped after 72h, regardless of fever.The antibiotics used will be piperacillin tazobactam for high-risk patients and amoxycillin-clavulanate + ciprlofloxacin for low-risk patients (defined by MASCC scoring system). Alternatives in case of penicillin allergy will be ceftazidine and levofloxacin, respectively.

Other: Early antibiotic discontinuation

Usual practice

OTHER

Antibiotic treatment continued according to accepted guidelines and current clinical practice. The antibiotics used will be piperacillin tazobactam for high-risk patients and amoxycillin-clavulanate + ciprlofloxacin for low-risk patients (defined by MASCC scoring system). Alternatives in case of penicillin allergy will be ceftazidine and levofloxacin, respectively.

Other: Usual practice

Interventions

Early antibiotic discontinuationOTHER

Antibiotic treatment for unexplained febrile neutropenia stopped after 72 hours, regardless of fever

Early antibiotic discontinuation
Usual practiceOTHER

Continued antibiotic treatment as accepted by guidelines for febrile neutropenia

Usual practice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults \>18 years providing signed informed consent
  • Patients with solid tumors, lymphoma, multiple myeloma or chronic lymphocytic leukemia, regardless of disease status or previous chemotherapy
  • Documented febrile neutropenia
  • No clinically or microbiologically documented infection after 72 hours

You may not qualify if:

  • Previous enrollment in this study
  • Concurrent participation in another interventional trial
  • Severe sepsis or septic shock
  • Acute leukemia, autologous or allogeneic hematopoietic stem-cell transplantation
  • Diarrhea suspected by treating physician to be Irinotecan induced
  • Any antibiotic treatment for \>48h in the last week before enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center, Beilinson Hospital

Petah Tikvah, Israel

Location

MeSH Terms

Conditions

Febrile Neutropenia

Condition Hierarchy (Ancestors)

NeutropeniaAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • Mical Paul, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

  • Leonard Leibovici, Prof

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

  • Dafna Yahav, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 17, 2011

First Posted

October 12, 2011

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2015

Last Updated

June 7, 2013

Record last verified: 2013-06

Locations

IL(1)