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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 May 2023 |
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Main ID: |
NCT03494959 |
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Date of registration:
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05/04/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pentaglobin in CRE and PA Neutropenic Infections
PENTALLO |
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Scientific title:
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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) |
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Date of first enrolment:
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December 6, 2019 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03494959 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Italy
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Contacts
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Name:
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Fabio Ciceri |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ospedale San Rafafele |
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Name:
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Angela Gheorghiu |
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Address:
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Telephone:
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0039 02 2643 6293 |
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Email:
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segreteria.presidenza@gitmo.it |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Septic Shock
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Intervention(s)
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Drug: Pentaglobin
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Primary Outcome(s)
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Non-Relapse Mortality
[Time Frame: at 4 months from the start of intensive treatment.]
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Overall Survival
[Time Frame: at 4 months from the start of intensive treatment]
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Sepsis-related mortality
[Time Frame: day +30 from the onset of neutropenic fever]
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Secondary ID(s)
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GITMO PENTALLO
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2018-001344-57
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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