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

Phase 2

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

• Registration Number: NCT03733340
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-06
• Last Update Submitted: 2018-11-06
• Study First Posted: 2018-11-07
• Last Update Posted: 2018-11-07
• Study Start: 2018-12-01
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Infectious incidence	pre-engraftment in allo-HSCT

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	2 years
Incidence of acute GVHD	100 days

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China