Short vs Prolonged Antibiotic Treatment for Hospitalized Hemato-oncology Patients With Febrile Neutropenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-07-31

Brief Summary

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Neutropenic fever is a life threatening condition that is not rare in patients suffering from hematologic disorders, and of paramount importance to early and effective treatment. In this trial we concentrate on hospitalized patients with hematologic malignancies who develop neutropenic fever.

In recent years, several studies were conducted to examine possible changes in the conventional empirical treatment, assuming that administration of the antibiotics in a prolonged infusion would allow for a greater fT \> MIC that will lead to a better efficacy.

These studies were carried out in different populations and there is only limited information about the importance of continuous infusion therapy in patients with hematologic diseases with neutropenic fever.

Research goals: The main goal is to compare between two groups of hematologic patients with neutropenic fever, The first group will receive antibiotic therapy in extended infusion, and the second (control) group will receive the treatment in a fixed time.

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Detailed Description

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METHODS: Each patient who will be hospitalized in the Department of Bone Marrow Transplantation and which meets the Inclusion criteria for, will be offered to participate in the study. If fever appears during hospitalization empirical treatment of neutropenia will be initiated performed in accordance with the allocation of the patient in the study. Therapeutic success is defined as a combination of several clinical parameters, including: a decline in Fever, the recurrence of fever and improvement in infection.

METHODS: Study format - Prospective unblinded randomized trial.

Neutropenic fever measurement will be set above the fold of 38.3 ° C or fever over 38.0 ° C lasting more than an hour. Neutropenia is defined as absolute neutrophil count (ANC) less than 500 cells / mm3, or expected to fall below this value for the next 48 hours.

Primary care would be one of three options:

1. Tazocin: 4.5gr, TID, I.V. Or
2. Fortum (Ceftazidim): 2.0gr, TID, I.V. - for penicillin-sensitive patients. Or
3. Meropenem: 1.0gr, TID, I.V. - In cases of hypotension not responding to fluids resuscitation, and in consultation with the infectious diseases unit - we will start empirical treatment with Meropenem.

Supplementation of Vancomycin will be at the discretion of the treating physician.

Antibiotic therapy will be replaced, in coordination with the Department of Infectious Diseases in the following cases:

1. The fever does not decrease after 24 hours
2. The patient is not hemodynamically stable or developes an organ failure
3. Evolving of sensitivity response (allergy) suspected to be a response to antibiotic patient is treated with.
4. sensitivity response was received from the laboratory culture Bacteriologist demanding a change in antibiotics.

Replacement of antibiotic therapy is defined as a failure as defined by the primary endpoint. In such a case, continued treatment of the patient would be according to the BMT unit protocol for treatment for neutropenic fever.

Conditions

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Fever Febrile Neutropenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prolonged Infusion of antibiotics

Prolonged (4 hours) Infusion of antibiotics.

Intervention:

Primary care would be one of three options:

1. Piperacillin/tazobactam : 4.5gr, TID, I.V.

Or
2. Fortum (Ceftazidim): 2.0gr, TID, I.V. - for penicillin-sensitive patients.

Or
3. Meropenem: 1.0gr, TID, I.V.

Supplementation of Vancomycin will be at the discretion of the treating physician.

Group Type EXPERIMENTAL

Piperacillin/tazobactam

Intervention Type DRUG

Initial treatment will be with Piperacillin + Tazobactam

Ceftazidim

Intervention Type DRUG

Patient with sensitivity to penicillin will receive Ceftazidim

Meropenem

Intervention Type DRUG

In cases of hypotension that do not respond to fluids resuscitation , and in consultation with the infectious diseases unit - we will start empirical treatment with Meropenem

Vancomycin

Intervention Type DRUG

Supplementation of Vancomycin will be at the discretion of the treating physician

Fixed time infusion of antibiotics

Fixed time (half and hour) infusion of antibiotics.

Intervention:

Primary care would be one of three options:

1. Piperacillin/tazobactam : 4.5gr, TID, I.V.

Or
2. Fortum (Ceftazidim): 2.0gr, TID, I.V. - for penicillin-sensitive patients.

Or
3. Meropenem: 1.0gr, TID, I.V.

Supplementation of Vancomycin will be at the discretion of the treating physician/

Group Type ACTIVE_COMPARATOR

Piperacillin/tazobactam

Intervention Type DRUG

Initial treatment will be with Piperacillin + Tazobactam

Ceftazidim

Intervention Type DRUG

Patient with sensitivity to penicillin will receive Ceftazidim

Meropenem

Intervention Type DRUG

In cases of hypotension that do not respond to fluids resuscitation , and in consultation with the infectious diseases unit - we will start empirical treatment with Meropenem

Vancomycin

Intervention Type DRUG

Supplementation of Vancomycin will be at the discretion of the treating physician

Interventions

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Piperacillin/tazobactam

Initial treatment will be with Piperacillin + Tazobactam

Intervention Type DRUG

Ceftazidim

Patient with sensitivity to penicillin will receive Ceftazidim

Intervention Type DRUG

Meropenem

In cases of hypotension that do not respond to fluids resuscitation , and in consultation with the infectious diseases unit - we will start empirical treatment with Meropenem

Intervention Type DRUG

Vancomycin

Supplementation of Vancomycin will be at the discretion of the treating physician

Intervention Type DRUG

Other Intervention Names

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Tazocin Fortum Ceftazidim Non

Eligibility Criteria

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Inclusion Criteria

1. Patients who are able to sign an informed consent form
2. Hospitalized patients for one of the following reasons:

* Induction or consolidation for Acute Leukemia
* Patients Hospitalized for Autologous BMT
* Patients Hospitalized for Allogeneic BMT.

Exclusion Criteria

1. Patients under the age of 18.
2. Patients who are unable to provide informed consent.
3. Patients with acute lymphatic leukemia hospitalized for maintenance treatment
4. Patients who will not be staying for the entire duration of neutropenia in house.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No