Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Allogenetic Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
| Antibacterial Prophylaxis | — | UNRESOLVED | — |
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | PROBABILISTIC | 0.70 |
| Imipenem | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imipenem | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Imipenem prophylaxis group
- description
- Imipenem: 1g q8h i.v. daily for 5 consecutive days before the onset of conditioning of allo-HSCT
- interventionNames
- Drug: Imipenem
- type
- NO_INTERVENTION
- label
- Blank control group
- description
- Without antibacterial prophylaxis at the onset of condition of all-HSCT
Primary outcomes (1)
- measure
- Infectious incidence
- timeFrame
- pre-engraftment in allo-HSCT
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available