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

November 6, 2018 updated by: Qifa Liu, Nanfang Hospital of Southern Medical University

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
        • Contact:
          • Liu Qifa
          • Phone Number: +86-020-61641613
        • Principal Investigator:
          • Liu Qifa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infectious incidence
Time Frame: pre-engraftment in allo-HSCT
pre-engraftment in allo-HSCT

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: 2 years
2 years
Incidence of acute GVHD
Time Frame: 100 days
100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (Actual)

November 7, 2018

Study Record Updates

Last Update Posted (Actual)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Bacteria clean pre-allo-HSCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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