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

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03733340

Enrollment

250

Registered

2018-11-07

Start date

2018-12-01

Completion date

2019-12-01

Last updated

2018-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allogenetic Hematopoietic Stem Cell Transplantation, Antibacterial Prophylaxis, Hematological Malignancies, Imipenem

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.

Interventions

DRUGImipenem

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Infectious incidence	pre-engraftment in allo-HSCT

Secondary

Measure	Time frame
Overall survival (OS)	2 years
Incidence of acute GVHD	100 days

Countries

China

Contacts

Primary ContactZhao Ke

124821741@qq.com+86-020-61641613

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026