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Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia: Randomized-controlled Trial


N/A
18 Years
N/A
Not Enrolling
Both
Febrile Neutropenia

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Trial Information

Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia: Randomized-controlled Trial


Febrile neutropenia remains a major cause of morbidity in solid cancer patients. There is an
unresolved question regarding the appropriate duration of antibiotic treatment for patients
with febrile neutropenia of unknown origin. Current guidelines recommend at least seven days
of antibiotic treatment. Several studies have demonstrated the safety of early antibiotic
discontinuation in patients with febrile neutropenia. We plan an open label randomized
controlled trial to compare early antibiotic discontinuation to the accepted prolonged
antibiotic treatment protocol


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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)

Outcome Time Frame:

After day 7 from randomization until day 30

Safety Issue:

No

Principal Investigator

Mical Paul, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rabin Medical Center

Authority:

Israel: Ministry of Health

Study ID:

RabinMC6249

NCT ID:

NCT01450241

Start Date:

January 2012

Completion Date:

January 2015

Related Keywords:

  • Febrile Neutropenia
  • Febrile neutropenia
  • Unexplained fever
  • Duration
  • Short-term antibiotic treatment
  • Fever
  • Neutropenia

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