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

NCT03733340 | Unknown Phase 2

• 1 other identifier: Bacteria clean pre-allo-HSCT
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Infectious incidence

  pre-engraftment in allo-HSCT

Secondary Outcomes (2)

• Overall survival (OS)

  2 years

• Incidence of acute GVHD

  100 days

Study Arms (2)

Imipenem prophylaxis group

EXPERIMENTAL

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

Drug: Imipenem

Blank control group

NO INTERVENTION

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

Interventions

Imipenem DRUG

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

Imipenem prophylaxis group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Imipenem

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Liu Qifa

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Ke

CONTACT

+86-020-61641613; 124821741@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 7, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 7, 2018

Record last verified: 2018-08

Locations

CN (1)