Pentaglobin in CRE and PA Neutropenic Infections (NCT03494959) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pentaglobin in CRE and PA Neutropenic Infections
Italy120 participantsStarted 2019-12-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sepsis-related mortality
Timeframe: day +30 from the onset of neutropenic fever
2
Overall Survival
Timeframe: at 4 months from the start of intensive treatment
3
Non-Relapse Mortality
Timeframe: at 4 months from the start of intensive treatment.