Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation
|ClinicalTrials.gov Identifier: NCT01714557|
Recruitment Status : Unknown
Verified October 2012 by Wenrong Huang, Chinese PLA General Hospital.
Recruitment status was: Not yet recruiting
First Posted : October 26, 2012
Last Update Posted : October 26, 2012
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:
- No prophylaxic antibiotic
- Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas activity.
- Piperacillin/tazobactam as prophylaxis for neutropenia patients. Piperacillin/tazobactam has highest susceptibility rate among common anti-pseudomonas antibiotics.
|Condition or disease||Intervention/treatment||Phase|
|Neutropenia Hematopoietic Stem Cell Transplantation||Drug: Piperacillin Drug: Piperacillin-tazobactam combination product||Not Applicable|
- Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.
- Randomize the neutropenia patients into 3 groups.
- Receive 3 regimen.
- Full record of clinical data, including background diseases, previous antibiotics within 90 days, febrile or not at the TOC.
- For patients developed febrile, imipenem will be prescribed, even if the patient received no prophylaxis. At the same time, the follow-up ended.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Piperacillin/Tazobactam for Prophylaxis in Patients of Neutropenia After Hematopoietic Stem Cell Transplantation - A Pilot Study|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||November 2014|
|No Intervention: No prophylaxis|
|Active Comparator: piperacillin||
4.0g q8h 3-5 days
Drug: Piperacillin-tazobactam combination product
4.5g q8h 3-5 days
Other Name: Tazocin
- febrile rate [ Time Frame: 3 weeks after beginning of prophylaxis ]In both group, how many patients developed febrile.
- Microbiologic efficacy in febrile patients [ Time Frame: 3 weeks after beginning of prophylaxis ]
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.
- Recovery rate from neutropenia [ Time Frame: 3 weeks after beginning of prophylaxis ]How many patients reached the ANC > 0.5×109/L more than 3 days.
- AE [ Time Frame: 3 weeks after beginning of prophylaxis ]How many patients developed unexpected medical events.
- Cost of drug and hospital-stay [ Time Frame: 3 weeks after beginning of prophylaxis ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714557
|Chinese PLA general hospital||Not yet recruiting|
|Beijing, Beijing, China|
|Contact: Wenrong Huang, Doctor firstname.lastname@example.org|
|Principal Investigator:||wenrong huang, Doctor||Employee|