Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia

Not Applicable

Completed

• Conditions: Febrile; Neutropenia; Hematopoietic Stem Cell Transplantation
• Interventions: Drug: Piperacillin-tazobactam combination product; Drug: Imipenem

• Registration Number: NCT01714570
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-07-04
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-26
• Study Start: 2012-11
• Primary Completion: 2014-03
• Status Verified: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-16
• Last Update Posted: 2014-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
piperacillin/tazobactam	Piperacillin-tazobactam combination product	-
imipenem/cilastatin	Imipenem	-

Primary Outcome Measures

Name	Time	Method
Clinical success rate.	3 weeks after beginning of empirical therapy	Resolve of clinical symptoms and signs, without change of therapy.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chinese PLA general hospital; 🇨🇳 Beijing, Beijing, China