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Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia

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ClinicalTrials.gov Identifier: NCT01714570
Recruitment Status : Completed
First Posted : October 26, 2012
Last Update Posted : April 17, 2014
Information provided by (Responsible Party):
Wenrong Huang, Chinese PLA General Hospital

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
Febrile Neutropenia Hematopoietic Stem Cell Transplantation Drug: Piperacillin-tazobactam combination product Drug: Imipenem Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Clinical success rate. [ Time Frame: 3 weeks after beginning of empirical therapy ]
    Resolve of clinical symptoms and signs, without change of therapy.

Secondary Outcome Measures :
  1. Microbiologic success rate [ Time Frame: 3 weeks after beginning of empirical therapy ]

    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.

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

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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult, Older Adult)
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.

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): NCT01714570

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China, Beijing
Chinese PLA general hospital
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
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Principal Investigator: wenrong huang, Doctor Employee
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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: October 26, 2012    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries
Piperacillin, Tazobactam Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action