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Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia

This study is currently recruiting participants.
Verified April 2013 by Chinese PLA General Hospital
Sponsor:
Information provided by (Responsible Party):
Wenrong Huang, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01714570
First received: July 4, 2012
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Fever
U.S. FDA Resources

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 ]

Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714570

Locations
China, Beijing
Chinese PLA general hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Wenrong Huang, Doctor     +86 10 66937079     huangwr301@yahoo.com.cn    
Principal Investigator: Wenrong Huang, Doctor            
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 5, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Fever
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 May 16, 2013