Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wenrong Huang, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01714570
First received: July 4, 2012
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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 Intervention
Febrile
Neutropenia
Hematopoietic Stem Cell Transplantation
Drug: Piperacillin-tazobactam combination product
Drug: Imipenem

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • Clinical success rate. [ Time Frame: 3 weeks after beginning of empirical therapy ] [ Designated as safety issue: No ]
    Resolve of clinical symptoms and signs, without change of therapy.


Secondary Outcome Measures:
  • Microbiologic success rate [ Time Frame: 3 weeks after beginning of empirical therapy ] [ Designated as safety issue: No ]

    Microbiologic success includes eradication, suspected eradication, and super-infection.

    1. 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
    2. No eradication: one or more baseline pathogens were persistent
    3. Relapse: the baseline pathogens transient absence reappeared during the therapy
    4. Alternative: the baseline pathogens were eradicated, but new ones appeared without any clinical signs and symptoms
    5. Re-infection: the baseline pathogens were eradicated, but new ones appeared with clinical signs and symptoms.

  • Adverse effect [ Time Frame: 3 weeks after beginning of empirical therapy ] [ Designated as safety issue: Yes ]
    The number of patients developed unexpected medical information at the 3 weeks after beginning of empirical therapy.

  • Cost of drug and therapy [ Time Frame: 3 weeks after beginning of empirical therapy ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: November 2012
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: piperacillin/tazobactam Drug: Piperacillin-tazobactam combination product
4.5g q6h, 5-10 days
Other Name: Tazocin
Active Comparator: imipenem/cilastatin Drug: Imipenem
0.5g q6h, 5-10 days
Other Name: Tienam

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.
  Eligibility

Ages Eligible for Study:   13 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714570

Locations
China, Beijing
Chinese PLA general hospital
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Principal Investigator: wenrong huang, Doctor Employee
  More Information

No publications provided

Responsible Party: Wenrong Huang, Associate director, Hematology, Chinese PLA General hospital, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01714570     History of Changes
Other Study ID Numbers: PTZ-20120702
Study First Received: July 4, 2012
Last Updated: April 16, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Fever
Neutropenia
Febrile Neutropenia
Body Temperature Changes
Signs and Symptoms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Piperacillin
Imipenem
Penicillanic Acid
Piperacillin-tazobactam combination product
Tazobactam
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014