Septic Shock Clinical Trial
— PENTALLOOfficial title:
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)
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliero-Universitaria Ospedali Riuniti | Ancona | |
Italy | Policlinico di Bari-Ematologia con trapianti | Bari | |
Italy | Ospedale San Orsola | Bologna | |
Italy | AO Spedali Civili di Brescia- USD - TMO Adulti | Brescia | |
Italy | Ospedale Binaghi | Cagliari | |
Italy | S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle | Cuneo | |
Italy | Cattedra di Ematologia - Azienda Ospedaliera di Careggi | Firenze | |
Italy | Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza | Foggia | |
Italy | Trapianti Midollo Osseo - Policlinico S. Martino | Genova | |
Italy | Policlinico VIto Fazzi | Lecce | |
Italy | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano | |
Italy | Ospedale San Raffaele | Milano | |
Italy | Ospedale Cardarelli | Napoli | |
Italy | Ospedale G. Da Saliceto di Piacenza | Piacenza | |
Italy | Cattedra di Ematologia - Policlinico | Roma | |
Italy | Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli | Roma | |
Italy | Policlinico Universitario Tor Vergata | Roma | |
Italy | Ospedale Moscati | Taranto | |
Italy | AOU CIttà della Salute e della Scienza | Torino | |
Italy | Clinica Ematologica - Policlinico Universitario | Udine |
Lead Sponsor | Collaborator |
---|---|
Gruppo Italiano Trapianto di Midollo Osseo |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sepsis-related mortality | 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 | day +30 from the onset of neutropenic fever | |
Primary | Overall Survival | is defined as the probability of survival irrespective of disease state at any point in time. Patients alive at their last follow-up are censored. It is analyzed by the Kaplan-Meier method, Log-Rank Test and parametric or semiparametric survival models. | at 4 months from the start of intensive treatment | |
Primary | Non-Relapse Mortality | It is defined as the probability of dying without previous occurrence of a relapse, which is a competing event | at 4 months from the start of intensive treatment. |
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