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

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ClinicalTrials.gov Identifier: NCT02463747
Recruitment Status : Unknown
Verified June 2015 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 4, 2015
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Fever Febrile Neutropenia Drug: Piperacillin/tazobactam Drug: Ceftazidim Drug: Meropenem Drug: Vancomycin Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Unblinded Randomized Trial to Examine Short vs Prolonged Antibiotic Treatment for Hospitalized Hemato-oncology Patients With Febrile Neutropenia
Study Start Date : June 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Fever
Drug Information available for: Ceftazidime

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 Name: Tazocin

Drug: Ceftazidim
Patient with sensitivity to penicillin will receive Ceftazidim
Other Name: 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 Name: Ceftazidim

Drug: Vancomycin
Supplementation of Vancomycin will be at the discretion of the treating physician
Other Name: 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 Name: Tazocin

Drug: Ceftazidim
Patient with sensitivity to penicillin will receive Ceftazidim
Other Name: 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 Name: Ceftazidim

Drug: Vancomycin
Supplementation of Vancomycin will be at the discretion of the treating physician
Other Name: Non




Primary Outcome Measures :
  1. 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.



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02463747


Contacts
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Contact: Ron Ram, MD +972-3-6974138 ronr@tlvmc.gov.il
Contact: Ronen Ben-Ami, MD +972-3-6974347 ronenba@tlvmc.gov.il

Locations
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Israel
Tel-Aviv Sourasky Medicak center / BMT Unit Not yet recruiting
Tel-Aviv, Israel, 6423906
Contact: Ron Ram, MD    +972-3-6974138    ronr@tlvmc.gov.il   
Contact: Shachar Porat, B.Sc.    +972-3-6972428    shacharp@tlvmc.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Dr. Ron Ram, MD Head of BMt Unit / hematology division

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: michal roll, Director of R & D - Tel Aviv Sourasky M C, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02463747     History of Changes
Other Study ID Numbers: 0143-15-TLV
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015
Keywords provided by michal roll, Tel-Aviv Sourasky Medical Center:
Neutropenic fever
extended infusion
beta-lactam
empiric antibiotic treatment
Additional relevant MeSH terms:
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Neutropenia
Febrile Neutropenia
Fever
Body Temperature Changes
Signs and Symptoms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Anti-Bacterial Agents
Vancomycin
Meropenem
Tazobactam
Piperacillin
Penicillins
Ceftazidime
Piperacillin, Tazobactam Drug Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action