ItAlian ReGistry Of pNeumoniA in immUnocompromised paTients (ARGONAUT)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSocieta Italiana di Pneumologia

About this trial

This multicentric, prospective study aims at:

evaluating the prevalence, etiology, characteristics, and 1one-year outcomes of immunocompromised patients hospitalized for Community-Acquired Pneumonia (CAP); conducting biochemical, microbiological and genetic analysis on collected samples.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

AIDS,

Aplastic anemia;

Asplenia;

Hematologic malignancy (e.g., lymphoma/acute or chronic myeloid leukemia/multiple myeloma);

Disqualifiers

None

Trial population

Immunosuppressed patients with Community-Acquired Pneumonia will be enrolled during hospitalization in Italian Pneumology, Infectious Diseases and Emergency Departments selected on their specific experteeze and know-how. Upon discharge, patients will be followed up at 30 days, 3 months, 6 months and 12 months after discharge.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

In-hospital mortality for all causes in immunocompromised patients with CAP enrolled in the study.

Recording in-hospital mortality for all causes in immunocompromised patients with CAP enrolled in the study.

Time frame
During hospitalization corresponding to study enrollment (1 day to 2 weeks of hospitalization on average)

Secondary outcomes

1

Time to clinical stability

Time to clinical stability calculated as the number of days from the date of admission to the date that the patient meets clinical stability criteria, up to 8 days. Clinical stability is defined as follows: improved clinical signs (improved cough and shortness of breath), lack of fever for at least 8 hours, improving leukocytosis (decreased at least 10% from the previous day), and tolerating oral intake.

Time frame
DAY 1 to 8
2

Mortality for all causes in immunocompromised patients with CAP

Mortality for all causes in immunocompromised patients with CAP enrolled in the study.

Time frame
30 days, 3 months, 6 months and 12 months after hospital discharge.
3

New hospitalizations in immunocompromised patients with CAP.

Recording new hospitalizations in immunocompromised patients with CAP enrolled in the study.

Time frame
30 days, 3 months, 6 months and 12 months after hospital discharge.
4

Prevalence of cardiovascular events in immunocompromised patients with CAP.

Prevalence of cardiovascular events in immunocompromised patients with CAP enrolled in the study.

Time frame
30 days, 3 months, 6 months and 12 months after hospital discharge.

Other outcomes

Sponsors and contacts

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