Incidence of Invasive Aspergillosis and Its Relation to Galactomannan Clinical Outcomes

NCT07621263 | Completed

• 1 other identifier: CEI2026-17/04/V1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to analyze the relationship between galactomannan index values and clinical outcomes , as well as to determine the annual and seasonal incidence of invasive aspergillosis in pediatric and adult patients with suspected or confirmed infection at Hospital H+ Querétaro. The main questions it aims to answer are:

• Are high galactomannan levels significantly associated with adverse clinical outcomes, such as mortality and longer hospital stays, in immunocompromised patients?
• How does the incidence of invasive aspergillosis vary annually and seasonally between March 2022 and March 2026? Researchers will compare patients with high galactomannan levels against those with low or negative levels to see if this biomarker can be used as a reliable tool to predict patient outcomes. The research team will:
• Collect and review clinical files of patients who had a galactomannan test from bronchoalveolar lavage samples.
• Record data on galactomannan levels, hospital stays, and patient recovery or complications.Identify risk factors and seasonal patterns of the infection.

Conditions

Invasive Aspergillosis

Keywords

Galactomannan; Aspergillus spp; Bronchoalveolar Lavage; Clinical Outcomes

Outcome Measures

Primary Outcomes (1)

• Incidence of Invasive Aspergillosis and Association of Galactomannan Index with Clinical Outcomes

  An analysis to determine the annual and seasonal incidence of Invasive Aspergillosis (IA) , alongside a quantitative evaluation of how Galactomannan (GM) index values relate to clinical outcomes in patients. The study will measure the association of GM levels with specific adverse endpoints, including patient mortality, length of hospital stay (estancia hospitalaria), intensive care unit (ICU) admission, and the development of clinical complications. Additionally, it will compare these clinical outcomes between patients with elevated GM levels against those with low or negative levels to evaluate GM's utility as a prognostic marker.

  From March 2022 to March 2026

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises both pediatric and adult patients who sought medical care at Hospital H+ Querétaro and presented with either a clinical suspicion or a confirmed diagnosis of invasive aspergillosis. Participants were identified through a review of hospital clinical records, specifically including those who underwent diagnostic evaluation by means of bronchoalveolar lavage during their hospitalization.

You may qualify if:

• Patients who underwent galactomannan determination testing in bronchoalveolar lavage (BAL) samples
• Tests performed during the period from March 2022 to March 2026.

You may not qualify if:

• Patients with galactomannan tests performed outside the established period (March 2022 to March 2026).
• Galactomannan tests performed using serum samples.

Sponsors & Collaborators

• Hospital H+ Queretaro: lead

Study Sites (1)

Hospital H+

Querétaro City, Querétaro, 7600, Mexico

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Eduardo Manzano Alexis

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: March 1, 2022
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

ME (1)