NCT06797648Not yet recruiting
Epidemiology of Infection in Acute Myeloid Leukemia (AML)
Epidemiology of Infection in AML, A European Haematology Association Survey
Source: ClinicalTrials.gov · Last updated 28 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In recent years, multiple factors have strongly impacted the epidemiology of infections in patients with acute myeloid leukemia. On the one hand, the availability of new effective antileukemic drugs (i.e. venetoclax, FLT-3 inhibitors, CPX-351) have expanded the pharmacological armamentarium. On the other hand, first, many of them inhere drug-drug interactions with azoles and fluoroquinolones, facing clinicians with the choice of whether to administer antimicrobial prophylaxis or not. Secondly, there is an increase in infections due to multi-resistant agents from both the bacterial and fungal field. Third, the onset of a viral pandemic that had high relevance in these patients in terms of morbidity and mortality. The aim of this survey is to collect information on the largest possible sample of patients with AML during induction/consolidation/relapsed-refractory treatment, regarding bacterial, viral, fungal infections. We will evaluate the incidence of the various types of infection in relation to the type of treatment that patients will undergo, in order to identify what should be the best antimicrobial prophylactic approach in each subset of patients.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 23 Jan 2025
- Start date
- 1 Mar 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06797648
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Mar 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with an AML diagnosis prior to March 2025 but who relapsed during the period under examination
- Patients relapsed after allo or auto-HSCT (Inclusion of post-transplant patients would create an evaluation bias due to the immunological alterations that the transplant procedure causes)
Other illness
- Hematological diseases, other than AML
Who the study is looking for
- Ability to sign the consent form
- Age ≥18 years
- New diagnosis of AML (only cases diagnosed after 01/03/2025), APL are included
- Patients not elegible to any kind of chemotherapy but only best supportive care (BSC)
- AML patients treated with induction treatment, consolidation treatment, or relapsed/refractory (for these latter patients the first diagnosis must not be prior to March 01, 2025)
- All kind of infectious diseases, including parasites.
- Clincally or microbiologically diagnosed infections, including FUO
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli Irccs, Uoc Ematologia Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.