- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03733340
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Zhao Ke
- Phone Number: +86-020-61641613
- Email: 124821741@qq.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510515
- Recruiting
- Nanfang Hospital, Southern Medical University
-
Contact:
- Zhao Ke
- Phone Number: +86-020-61641613
- Email: 124821741@qq.com
-
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
Additional Relevant MeSH Terms
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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