Clinical trial · Interventional
Pentaglobin in CRE and PA Neutropenic Infections
Pentaglobin As Early Adjuvant Treatment for Febrile Neutropenia in Acute Leukemia or Allogeneic Hematopoietic Stem Cell Transplant Patients Colonized by Carbapenem-resistant Enterobacteriaceae (CRE) or Pseudomonas Aeruginosa (PA)
- 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)
To demonstrate that the early addition of Pentaglobin to the best available antimicrobial therapy is able to reduce mortality and improve survival in neutropenic febrile acute leukemia or allo- Hematopoietic stem cell transplantation (HSCT) patients colonized by carbapenem-resistant Enterobacteriaceae or by any Pseudomonas aeruginosa.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Septic Shock | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pentaglobin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment with Pentaglobin
- description
- Patients should receive the best available first-line therapy, usually a combination therapy, based on the in vitro susceptibility results of the pre-treatment screening swab in combination to Pentaglobin 5ml/kg over a 12h i.v. infusion for 3 consecutive days.
- interventionNames
- Drug: Pentaglobin
Primary outcomes (3)
- measure
- Sepsis-related mortality
- timeFrame
- day +30 from the onset of neutropenic fever
- description
- Sepsis-related mortality is considered as the time from the onset of neutropenic fever to death caused by uncontrolled documented infection, in the absence of any other interfering cause of death
- measure
- Overall Survival
- timeFrame
- at 4 months from the start of intensive treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> or = 18 years * Performance status: ECOG \<3 * Diagnosis of acute myeloid leukemia or acute lymphoblastic leukemia candidate to intensive chemotherapy * Indication to allogeneic Hematopoietic stem cell transplantation (HSCT) for hematological cancers, including severe aplastic anemia (second transplants allowed) * Pre-treatment colonization by Carbapenem-resistant Enterobacteriaceae (CRE) or Pseudomonas aeruginosa (PA) documented by rectal and/or pharyngeal swab. * Pre-treatment bloodstream infection sustained by CRE or PA. * Written and signed informed consent Exclusion Criteria: * Uncontrolled systemic infection * Anaphylaxis or severe prior reactions to immunoglobulins preparation * Severe concomitant illness: * patients with severe renal impairment, i.e. patients on dialysis or prior renal transplantation or S-creatinine \> 3.0 x ULN or calculated (CKD-EPI) creatinine-clearance \< 50 ml/min * patients with severe pulmonary impairment (DLCOSB (Hb-adjusted)/or FEV1 \< 50 % or severe dyspnea at rest or requiring oxygen supply); * patients with severe cardiac impairment (LVEF \< 40 %) * patients with severe hepatic impairment (hyperbilirubinemia \> 3 x ULN or ALT / AST \> 5 x ULN). * patients who on the basis of the investigator's consideration are not able to give the informed consent
References
Publications (0)
Data not yet available