Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation

Condition(s) targeted: Neutropenia; Hematopoietic Stem Cell Transplantation

Intervention: Piperacillin (Drug); Piperacillin-tazobactam combination product (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Chinese PLA General Hospital

Official(s) and/or principal investigator(s):
wenrong huang, Doctor, Principal Investigator, Affiliation: Employee

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.

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

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

Primary outcome: febrile rate

Secondary outcome:

Microbiologic efficacy in febrile patients

Recovery rate from neutropenia

AE

Cost of drug and hospital-stay

Detailed 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.

Minimum age: 13 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Chinese PLA general hospital, Beijing, Beijing, China; Not yet recruiting
Wenrong Huang, Doctor, Email: huangwr301@yahoo.com.cn

Starting date: September 2012
Last updated: October 25, 2012