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

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03733340

Collaborator

(none)

250

Enrollment

Location

Arms

Anticipated Duration (Months)

20.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Antibacterial Prophylaxis Hematological Malignancies Allogenetic Hematopoietic Stem Cell Transplantation Imipenem	Drug: Imipenem	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Imipenem prophylaxis group

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

Drug: Imipenem

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

No Intervention: Blank control group

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

Outcome Measures

Primary Outcome Measures

Infectious incidence [pre-engraftment in allo-HSCT]

Secondary Outcome Measures

Overall survival (OS) [2 years]
Incidence of acute GVHD [100 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	China	510515

Sponsors and Collaborators

Nanfang Hospital of Southern Medical University

Investigators

Principal Investigator: Liu Qifa, Nanfang Hospital of Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qifa Liu, Prof., Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT03733340

Other Study ID Numbers:

Bacteria clean pre-allo-HSCT

First Posted:

Nov 7, 2018

Last Update Posted:

Nov 7, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Hematologic Neoplasms

Imipenem

Study Results

No Results Posted as of Nov 7, 2018