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

Hematological Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03733340
• Other study ID #: Bacteria clean pre-allo-HSCT
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: August 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: Zhao Ke
• Phone: +86-020-61641613
• Email: 124821741[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allogenetic Hematopoietic Stem Cell Transplantation
• Antibacterial Prophylaxis
• Hematological Malignancies
• Imipenem
• Neoplasms

Intervention

Drug:
• Imipenem
Imipenem: A wide-spectre antibiotic from the carbapenem group Other name: Imipenem-cilastatin

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infectious incidence		pre-engraftment in allo-HSCT
Secondary	Overall survival (OS)		2 years
Secondary	Incidence of acute GVHD		100 days