Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: Neutropenia; Hematopoietic Stem Cell Transplantation

Treatments: Drug: Piperacillin; Drug: Piperacillin-tazobactam combination product

Study type: Interventional

Funder types: Other

Identifiers

NCT01714557

TZP-HEM-20120608

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 13 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 3 patient groups

No prophylaxis

No Intervention group

piperacillin

Active Comparator group

Treatment:

Drug: Piperacillin

piperacillin/tazobactam

Experimental group

Treatment:

Drug: Piperacillin-tazobactam combination product