Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation

Neutropenia Clinical Trial

Official title:

Piperacillin/Tazobactam for Prophylaxis in Patients of Neutropenia After Hematopoietic Stem Cell Transplantation - A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01714557
• Other study ID #: TZP-HEM-20120608
• Status: Not yet recruiting
• Phase: N/A
• First received: July 4, 2012
• Last updated: October 25, 2012
• Start date: September 2012
• Est. completion date: November 2014

Study information

• Verified date: October 2012
• 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. Almost all neutropenia will suffer from febrile without prophylactic antibiotics. IDSA recommended fluoroquinolones as prophylaxis in neutropenia patients of high risks, while in China, major pathogens possess high resistance to fluoroquinolones. It is not clear whether prophylaxis is of benefit, nor the appropriate prophylaxis regimen.

The current study will evaluate the three different regimen:

1. No prophylaxic antibiotic

2. Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas activity.

3. Piperacillin/tazobactam as prophylaxis for neutropenia patients. Piperacillin/tazobactam has highest susceptibility rate among common anti-pseudomonas antibiotics.

Description:

1. Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.

2. Randomize the neutropenia patients into 3 groups.

3. Receive 3 regimen.

4. Full record of clinical data, including background diseases, previous antibiotics within 90 days, febrile or not at the TOC.

5. For patients developed febrile, imipenem will be prescribed, even if the patient received no prophylaxis. At the same time, the follow-up ended.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: November 2014
• Est. primary completion date: September 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: Prevention

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplantation
• Neutropenia

Intervention

Drug:
• Piperacillin
4.0g q8h 3-5 days
• Piperacillin-tazobactam combination product
4.5g q8h 3-5 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	febrile rate	In both group, how many patients developed febrile.	3 weeks after beginning of prophylaxis	Yes
Secondary	Microbiologic efficacy in febrile patients	The success rate and failure rate will be calculated.; The microbiologic culture is positive at 3 weeks of prophylaxis, showing pathogen sensitive to Piperacillin/tazobactam, the case will be evaluated as breakthrough infection, that means microbiologic failure.; The microbiologic culture is negative at 3 weeks of prophylaxis,, or positive fungus or non-typical organisms, the case will be evaluated as microbiologic success.	3 weeks after beginning of prophylaxis	No
Secondary	Recovery rate from neutropenia	How many patients reached the ANC > 0.5×109/L more than 3 days.	3 weeks after beginning of prophylaxis	No
Secondary	AE	How many patients developed unexpected medical events.	3 weeks after beginning of prophylaxis	Yes
Secondary	Cost of drug and hospital-stay		3 weeks after beginning of prophylaxis	No