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Clinical Trials/NCT01714570
NCT01714570CompletedNot Applicable

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

Chinese PLA General Hospital1 site in 1 country123 target enrollmentStarted: November 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
123
Locations
1
Primary Endpoint
Clinical success rate.

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
13 Years to 65 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 13-65 years
  • received Autologous or Allogeneic hematopoietic stem cell transplantation.
  • ECOG score 0-
  • ICF is available.

Exclusion Criteria

  • Allergic to any therapy drug.
  • Documented infection before neutropenia.
  • Renal dysfunction.
  • Suffering from central nervous system or mental disease.

Arms & Interventions

piperacillin/tazobactam

Experimental

Intervention: Piperacillin-tazobactam combination product (Drug)

imipenem/cilastatin

Active Comparator

Intervention: Imipenem (Drug)

Outcomes

Primary Outcomes

Clinical success rate.

Time Frame: 3 weeks after beginning of empirical therapy

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

Secondary Outcomes

  • Microbiologic success rate(3 weeks after beginning of empirical therapy)
  • Adverse effect(3 weeks after beginning of empirical therapy)
  • Cost of drug and therapy(3 weeks after beginning of empirical therapy)

Investigators

Sponsor
Chinese PLA General Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wenrong Huang

Associate director, Hematology, Chinese PLA General hospital

Chinese PLA General Hospital

Study Sites (1)

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