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

Primary Purpose

Antibacterial Prophylaxis, Hematological Malignancies, Allogenetic Hematopoietic Stem Cell Transplantation

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Imipenem
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Antibacterial Prophylaxis

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Imipenem prophylaxis group

Blank control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Infectious incidence

Secondary Outcome Measures

Overall survival (OS)
Incidence of acute GVHD

Full Information

First Posted
November 6, 2018
Last Updated
November 6, 2018
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03733340
Brief Title
Antibacterial Prophylaxis vs no Prophylaxis for Hematological Malignancies Patients Before Allo-HSCT
Official Title
Antibacterial Prophylaxis With Imipenem vs no Prophylaxis for Hematological Malignancies Patients Before Allogenetic Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibacterial Prophylaxis, Hematological Malignancies, Allogenetic Hematopoietic Stem Cell Transplantation, Imipenem

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imipenem prophylaxis group
Arm Type
Experimental
Arm Description
Imipenem: 1g q8h i.v. daily for 5 consecutive days before the onset of conditioning of allo-HSCT
Arm Title
Blank control group
Arm Type
No Intervention
Arm Description
Without antibacterial prophylaxis at the onset of condition of all-HSCT
Intervention Type
Drug
Intervention Name(s)
Imipenem
Intervention Description
Imipenem: A wide-spectre antibiotic from the carbapenem group Other name: Imipenem-cilastatin
Primary Outcome Measure Information:
Title
Infectious incidence
Time Frame
pre-engraftment in allo-HSCT
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
2 years
Title
Incidence of acute GVHD
Time Frame
100 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhao Ke
Phone
+86-020-61641613
Email
124821741@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Qifa
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhao Ke
Phone
+86-020-61641613
Email
124821741@qq.com
First Name & Middle Initial & Last Name & Degree
Liu Qifa
Phone
+86-020-61641613
First Name & Middle Initial & Last Name & Degree
Liu Qifa

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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