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Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative treatment for a variety of hematologic malignancies. Bacterial infections remain a common complication of allo-HSCT, especially in the pre-engraftment phase. Pre-engraftment neutropenia typically lasts for up to 2 weeks in autologous HSCT but is considerably longer in allogeneic HSCT recipients who receive myeloablative conditioning regimens. This is a prospective, randomized, controlled, phase II/III clinical trial that aims to investigate the beneficial and harmful effects of prophylactic use of imipenem in patients with hematological malignancies before allo-HSCT. All patients aged above 14 years, diagnosed with hematological malignancies and ready to undergo allo-HSCT, no active infection within 3 weeks before allo-HSCT, with a normal CT scan-chest before entering the transplantation cabin and willing to participate in the trial will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imipenem prophylaxis group | Experimental | Imipenem: 1g q8h i.v. daily for 5 consecutive days before the onset of conditioning of allo-HSCT |
|
| Blank control group | No Intervention | Without antibacterial prophylaxis at the onset of condition of all-HSCT |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imipenem | Drug | Imipenem: A wide-spectre antibiotic from the carbapenem group Other name: Imipenem-cilastatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infectious incidence | pre-engraftment in allo-HSCT |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | 2 years | |
| Incidence of acute GVHD | 100 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhao Ke | Contact | +86-020-61641613 | 124821741@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Liu Qifa | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D015378 | Imipenem |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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