Pentaglobin in CRE and PA Neutropenic Infections

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano Trapianto di Midollo Osseo
• Treatments: Immunoglobulin A; Immunoglobulin M

Criteria

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