Antibacterial Prophylaxis vs no Prophylaxis for Hematological Malignancies Patients Before Allo-HSCT

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Antibacterial Prophylaxis With Imipenem vs no Prophylaxis for Hematological Malignancies Patients Before Allogenetic Hematopoietic Stem Cell Transplantation

Conditions
-----------------
Antibacterial Prophylaxis, Hematological Malignancies, Allogenetic Hematopoietic Stem Cell Transplantation, Imipenem

Intervention / Treatment
-----------------
* Drug: Imipenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged above 14 years; diagnosis with hematological malignancies and be 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. Exclusion Criteria: age < 14 years; active and documented infection at admission; with a abnormal CT scan-chest before entering the transplantation cabin; with any conditions not suitable for the trial; unwilling to participate in the trial.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imipenem prophylaxis group<br>Imipenem: 1g q8h i.v. daily for 5 consecutive days before the onset of conditioning of allo-HSCT | Drug: Imipenem<br>* Imipenem: A wide-spectre antibiotic from the carbapenem group Other name: Imipenem-cilastatin<br>|
| No Intervention: Blank control group<br>Without antibacterial prophylaxis at the onset of condition of all-HSCT | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious incidence |  | pre-engraftment in allo-HSCT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | 2 years | 
| Incidence of acute GVHD |  | 100 days |