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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Antibacterial Prophylaxis Hematological Malignancies Allogenetic Hematopoietic Stem Cell Transplantation Imipenem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Imipenem prophylaxis group

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

Group Type EXPERIMENTAL

Imipenem

Intervention Type DRUG

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

Blank control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Imipenem

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No