Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia

Neutropenia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714570
• Other study ID #: PTZ-20120702
• Status: Completed
• Phase: N/A
• First received: July 4, 2012
• Last updated: April 16, 2014
• Start date: November 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Febrile
• Fever
• Hematopoietic Stem Cell Transplantation
• Neutropenia

Intervention

Drug:
• Piperacillin-tazobactam combination product
4.5g q6h, 5-10 days
• Imipenem
0.5g q6h, 5-10 days

Locations

Country	Name	City	State
China	Chinese PLA general hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success rate.	Resolve of clinical symptoms and signs, without change of therapy.	3 weeks after beginning of empirical therapy	No
Secondary	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	No
Secondary	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	Yes
Secondary	Cost of drug and therapy		3 weeks after beginning of empirical therapy	No