Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation
Recruitment status was: Not yet recruiting
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.
|Neutropenia Hematopoietic Stem Cell Transplantation||Drug: Piperacillin Drug: Piperacillin-tazobactam combination product|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Piperacillin/Tazobactam for Prophylaxis in Patients of Neutropenia After Hematopoietic Stem Cell Transplantation - A Pilot Study|
- 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 ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
|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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714557
|Chinese PLA general hospital||Not yet recruiting|
|Beijing, Beijing, China|
|Contact: Wenrong Huang, Doctor email@example.com|
|Principal Investigator:||wenrong huang, Doctor||Employee|