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NCT Number: NCT01714570

Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia

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.

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Key information

Conditions

Febrile Agranulocytosis Body Temperature Changes Cytopenia Fever Hematologic Diseases Hematopoietic Stem Cell Transplantation Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neutropenia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

13 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese PLA general hospital

Beijing, Beijing Municipality, 100853, China

About this study

  • Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.
  • Randomize the febrile patients into 2 groups.
  • Therapy group receive piperacillin/tazobactam, 4.5g q6h iv. Control group receive imipenem/cilastatin, 0.5g q6h. Duration will be 5-10 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Piperacillin-tazobactam combination product

Drug

4.5g q6h, 5-10 days

Other names: Tazocin

Imipenem

Drug

0.5g q6h, 5-10 days

Other names: Tienam

Primary outcomes

  1. Clinical success rate.

    Time frame: 3 weeks after beginning of empirical therapy

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

Secondary outcomes

  1. Microbiologic success rate

    Time frame: 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

    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

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 26, 2012
Registry last updated
Apr 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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