Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia

NCT01714570 | Completed DMC

• 1 other identifier: PTZ-20120702
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Febrile; Neutropenia; Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Clinical success rate.

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

  3 weeks after beginning of empirical therapy

Secondary Outcomes (3)

• 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

Study Arms (2)

piperacillin/tazobactam

EXPERIMENTAL

Drug: Piperacillin-tazobactam combination product

imipenem/cilastatin

ACTIVE COMPARATOR

Drug: Imipenem

Interventions

Piperacillin-tazobactam combination product DRUG

4.5g q6h, 5-10 days

Also known as: Tazocin

piperacillin/tazobactam

Imipenem DRUG

0.5g q6h, 5-10 days

Also known as: Tienam

imipenem/cilastatin

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 13-65 years
• received Autologous or Allogeneic hematopoietic stem cell transplantation.
• ECOG score 0-1.
• ICF is available.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA general hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Fever; Neutropenia

Interventions

Piperacillin, Tazobactam Drug Combination; Imipenem; Cilastatin, Imipenem Drug Combination

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Thienamycins; Carbapenems; Cilastatin; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• wenrong huang, Doctor

  Employee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate director, Hematology, Chinese PLA General hospital

Study Record Dates

• First Submitted: July 4, 2012
• First Posted: October 26, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 17, 2014

Record last verified: 2014-04

Locations

CN (1)