ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 25 of 28 for:    "Klebsiella"

Pentaglobin in CRE and PA Neutropenic Infections (PENTALLO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03494959
Recruitment Status : Not yet recruiting
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Trapianto di Midollo Osseo

Brief 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.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Pentaglobin Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Treatment with Pentaglobin
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.
Drug: Pentaglobin
Antimicrobial treatment active against the multidrug-resistant strain should be started in case of neutropenic fever (oral temperature ≥38.3°C or temperature ≥38.0°C sustained over a one-hour period). 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. Empirical treatment should be subsequently streamlined according to microbiological results (both positive and negative). Pentaglobin should be started within 12h from the onset of fever, regardless of the presence of hemodynamic stability.




Primary Outcome Measures :
  1. Sepsis-related mortality [ Time Frame: day +30 from the onset of neutropenic fever ]
    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

  2. Overall Survival [ Time Frame: at 4 months from the start of intensive treatment ]
    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.

  3. Non-Relapse Mortality [ Time Frame: at 4 months from the start of intensive treatment. ]
    It is defined as the probability of dying without previous occurrence of a relapse, which is a competing event



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494959


Contacts
Contact: Benedetto Bruno 0039 011 26433903 benedetto.bruno@unito.it
Contact: Sonia Mammoliti 0039 010 5185919 sonia.mammoliti@hsanmartino.it

Locations
Italy
Ospedale San Orsola
Bologna, Italy
Ospedale San Raffaele
Milano, Italy
Cattedra di Ematologia - Policlinico
Roma, Italy
AOU CIttà della Salute e della Scienza
Torino, Italy
Sponsors and Collaborators
Gruppo Italiano Trapianto di Midollo Osseo
Investigators
Principal Investigator: Fabio Ciceri Ospedale San Rafafele

Responsible Party: Gruppo Italiano Trapianto di Midollo Osseo
ClinicalTrials.gov Identifier: NCT03494959     History of Changes
Other Study ID Numbers: GITMO PENTALLO
2018-001344-57 ( EudraCT Number )
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gruppo Italiano Trapianto di Midollo Osseo:
Pentaglobin
Carbapenem-resistant Klebsiella pneumoniae
Pseudomonas aeruginosa
febrile neutropenia
infection-related mortality

Additional relevant MeSH terms:
Shock, Septic
Febrile Neutropenia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Immunoglobulin A
Immunoglobulin M
Immunologic Factors
Physiological Effects of Drugs