Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia

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

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.

Study Overview

• Status: Completed
• Conditions: Neutropenia; Hematopoietic Stem Cell Transplantation; Febrile
• Intervention / Treatment: Drug: Piperacillin-tazobactam combination product; Drug: Imipenem

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 Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success rate.	Resolve of clinical symptoms and signs, without change of therapy.	3 weeks after beginning of empirical therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiologic success rate	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.	3 weeks after beginning of empirical therapy
Adverse effect	The number of patients developed unexpected medical information at the 3 weeks after beginning of empirical therapy.	3 weeks after beginning of empirical therapy
Cost of drug and therapy		3 weeks after beginning of empirical therapy

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Principal Investigator: wenrong huang, Doctor, Employee

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: July 4, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (Estimate): October 26, 2012

Study Record Updates

• Last Update Posted (Estimate): April 17, 2014
• Last Update Submitted That Met QC Criteria: April 16, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Body Temperature Changes; Heat Stress Disorders; Neutropenia; Hyperthermia; Fever; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Imipenem; Piperacillin; Tazobactam; Piperacillin, Tazobactam Drug Combination
• Other Study ID Numbers: PTZ-20120702