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

June 2, 2015 updated by: michal roll, Tel-Aviv Sourasky Medical Center

Prospective Unblinded Randomized Trial to Examine Short vs Prolonged Antibiotic Treatment for Hospitalized Hemato-oncology Patients With Febrile Neutropenia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Tel-Aviv, Israel, 6423906
        • Tel-Aviv Sourasky Medicak center / BMT Unit
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Piperacillin/tazobactam
Initial treatment will be with Piperacillin + Tazobactam
Other Names:
  • Tazocin
Drug: Ceftazidim
Patient with sensitivity to penicillin will receive Ceftazidim
Other Names:
  • Fortum
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
Other Names:
  • Ceftazidim
Drug: Vancomycin
Supplementation of Vancomycin will be at the discretion of the treating physician
Other Names:
  • Non
Active Comparator: 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/
Drug: Piperacillin/tazobactam
Initial treatment will be with Piperacillin + Tazobactam
Other Names:
  • Tazocin
Drug: Ceftazidim
Patient with sensitivity to penicillin will receive Ceftazidim
Other Names:
  • Fortum
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
Other Names:
  • Ceftazidim
Drug: Vancomycin
Supplementation of Vancomycin will be at the discretion of the treating physician
Other Names:
  • Non

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A successful response to treatment
Time Frame: Interim analysis is planed after 1 year , when a recruitment of 50 patients is expected

A successful response to treatment will be defined by a combination of all the following:

A. A defervescence of fever for at least 48 hours. B. Disappearance or improvement of clinical signs and symptoms of infection.

C. No: bacteremia / re-emergence of fever / signs of infection within 5 days from starting of treatment.
Interim analysis is planed after 1 year , when a recruitment of 50 patients is expected

Secondary Outcome Measures

Outcome Measure
Time Frame
Breakthrough fever or Additional bacteremia
Time Frame: 5 days after primary treatment
5 days after primary treatment
Clostridium difficile infection
Time Frame: For the duration of hospital stay - an expected average of 4 weeks
For the duration of hospital stay - an expected average of 4 weeks
Survival
Time Frame: During 30 days from begining of treatment
During 30 days from begining of treatment
Duration of Hospitalization
Time Frame: For the duration of hospital stay - an expected average of 4 weeks
For the duration of hospital stay - an expected average of 4 weeks
Number of days of Neutropenia
Time Frame: For the duration of hospital stay - an expected average of 4 weeks
For the duration of hospital stay - an expected average of 4 weeks
Any systemic organ Failure (Renal / Hepatic / Cardio or pulmonary)
Time Frame: For the duration of hospital stay - an expected average of 4 weeks
For the duration of hospital stay - an expected average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Dr. Ron Ram, MD, Head of BMt Unit / hematology division

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

June 2, 2015

First Posted (Estimate)

June 4, 2015

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0143-15-TLV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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