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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01714557
Other study ID # TZP-HEM-20120608
Secondary ID
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


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
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