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

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Hematological Malignancies; Antibacterial Prophylaxis; Allogenetic Hematopoietic Stem Cell Transplantation; Imipenem

Treatments: Drug: Imipenem

Study type: Interventional

Funder types: Other

Identifiers

NCT03733340

Bacteria clean pre-allo-HSCT

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Imipenem prophylaxis group

Experimental group

Description:

Imipenem: 1g q8h i.v. daily for 5 consecutive days before the onset of conditioning of allo-HSCT

Treatment:

Drug: Imipenem

Blank control group

No Intervention group

Description:

Without antibacterial prophylaxis at the onset of condition of all-HSCT