Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 26, 2015
First Posted Date  ICMJE June 4, 2015
Last Update Posted Date June 4, 2015
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
  • Breakthrough fever or Additional bacteremia [ Time Frame: 5 days after primary treatment ]
  • Clostridium difficile infection [ Time Frame: For the duration of hospital stay - an expected average of 4 weeks ]
  • Survival [ Time Frame: During 30 days from begining of treatment ]
  • Duration of Hospitalization [ Time Frame: 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 ]
  • Any systemic organ Failure (Renal / Hepatic / Cardio or pulmonary) [ Time Frame: For the duration of hospital stay - an expected average of 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short vs Prolonged Antibiotic Treatment for Hospitalized Hemato-oncology Patients With Febrile Neutropenia
Official Title  ICMJE Prospective Unblinded Randomized Trial to Examine Short vs Prolonged Antibiotic Treatment for Hospitalized Hemato-oncology Patients With Febrile Neutropenia
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Fever
  • Febrile Neutropenia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: Piperacillin/tazobactam
    • Drug: Ceftazidim
    • Drug: Meropenem
    • Drug: Vancomycin
  • 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/

    Interventions:
    • Drug: Piperacillin/tazobactam
    • Drug: Ceftazidim
    • Drug: Meropenem
    • Drug: Vancomycin
Publications * Ram R, Halavy Y, Amit O, Paran Y, Katchman E, Yachini B, Kor S, Avivi I, Ben-Ami R. Extended vs Bolus Infusion of Broad-Spectrum β-Lactams for Febrile Neutropenia: An Unblinded, Randomized Trial. Clin Infect Dis. 2018 Sep 28;67(8):1153-1160. doi: 10.1093/cid/ciy258. Erratum in: Clin Infect Dis. 2018 Sep 14;67(7):1151.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 2, 2015)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02463747
Other Study ID Numbers  ICMJE 0143-15-TLV
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party michal roll, Tel-Aviv Sourasky Medical Center
Study Sponsor  ICMJE Tel-Aviv Sourasky Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr. Ron Ram, MD Head of BMt Unit / hematology division
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP