Clincosm LogoSign in Get a demo

Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01714570
Collaborator
(none)
123
Enrollment
1
Location
2
Arms
17
Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Neutropenia is very common in patients received hematopoietic stem cell transplantation, with median duration of about 14 days. In 2010 update, IDSA recommended Piperacillin/tazobactam as first-line mono-therapy for febrile patients with neutropenia of high risk. In china, the data of piperacillin/tazobactam for febrile neutropenia after hematopoietic stem cell transplantation is very limited.

The current study will evaluate the efficacy of piperacillin/tazobactam compared with imipenem/cilastatin for febrile neutropenia after transplantation.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

  1. Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.

  2. Randomize the febrile patients into 2 groups.

  3. Therapy group receive piperacillin/tazobactam, 4.5g q6h iv. Control group receive imipenem/cilastatin, 0.5g q6h. Duration will be 5-10 days.

Study Design

Study Type:
Interventional
Actual Enrollment :
123 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized, Open Label Study of Piperacillin/Tazobactam Versus Imipenem/Cilastin for Empirical Therapy of Febrile Patients With Neutropenia After Hematopoietic Stem Cell Transplantation
Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: piperacillin/tazobactam

Drug: Piperacillin-tazobactam combination product
4.5g q6h, 5-10 days
Other Names:
  • Tazocin

    		•
    Active Comparator: imipenem/cilastatin

    Drug: Imipenem
    0.5g q6h, 5-10 days
    Other Names:
  • Tienam

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical success rate. [3 weeks after beginning of empirical therapy]

      Resolve of clinical symptoms and signs, without change of therapy.

    Secondary Outcome Measures

    1. Microbiologic success rate [3 weeks after beginning of empirical therapy]

      Microbiologic success includes eradication, suspected eradication, and super-infection. Eradication or Presumed eradication: the baseline pathogens no longer present on the culture performed after completion of treatment. If no way to collect biologic sample(s) after treatment;, e.g. sputum, a presumed eradication will be concluded No eradication: one or more baseline pathogens were persistent Relapse: the baseline pathogens transient absence reappeared during the therapy Alternative: the baseline pathogens were eradicated, but new ones appeared without any clinical signs and symptoms Re-infection: the baseline pathogens were eradicated, but new ones appeared with clinical signs and symptoms.

    2. Adverse effect [3 weeks after beginning of empirical therapy]

      The number of patients developed unexpected medical information at the 3 weeks after beginning of empirical therapy.

    3. Cost of drug and therapy [3 weeks after beginning of empirical therapy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 13-65 years

    • received Autologous or Allogeneic hematopoietic stem cell transplantation.

    • ECOG score 0-1.

    • ICF is available.

    Exclusion Criteria:

    • Allergic to any therapy drug.

    • Documented infection before neutropenia.

    • Renal dysfunction.

    • Suffering from central nervous system or mental disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chinese PLA general hospital Beijing Beijing China 100853

    Sponsors and Collaborators

    • Chinese PLA General Hospital

    Investigators

    • Principal Investigator: wenrong huang, Doctor, Employee

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wenrong Huang, Associate director, Hematology, Chinese PLA General hospital, Chinese PLA General Hospital
    ClinicalTrials.gov Identifier:
    NCT01714570
    Other Study ID Numbers:
    • PTZ-20120702
    First Posted:
    Oct 26, 2012
    Last Update Posted:
    Apr 17, 2014
    Last Verified:
    Apr 1, 2014
    Additional relevant MeSH terms:
    Neutropenia
    Hyperthermia
    Fever
    Tazobactam
    Piperacillin
    Imipenem
    Piperacillin, Tazobactam Drug Combination

    Study Results

    No Results Posted as of Apr 17, 2014