Invasive AspergillosisNCT07621263
Incidence of Invasive Aspergillosis and Its Relation to Galactomannan Clinical Outcomes
An observational study of Invasive Aspergillosis, run by Hospital H+ Queretaro at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Invasive Aspergillosis
- How many people
- 150 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2022to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients who underwent galactomannan determination testing in bronchoalveolar lavage (BAL) samples
- Tests performed during the period from March 2022 to March 2026.
Who cannot join
- Patients with galactomannan tests performed outside the established period (March 2022 to March 2026).
- Galactomannan tests performed using serum samples.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Invasive Aspergillosis at Hospital H+ Querétaro and the Relationship Between Galactomannan and Clinical Outcomes
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:
Read more
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From March 2022 to March 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Mar 2022
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive AspergillosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital H+ Queretaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose J Zaragoza, MD MSc, Hospital H+ Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621263
- Sponsor's protocol ID
- CEI2026-17/04/V1
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Invasive Aspergillosis at Hospital H+ Querétaro and the Relationship Between Galactomannan and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07621263
- Acronym / sponsor ID
- CEI2026-17/04/V1
- Conditions
- Invasive Aspergillosis
- Keywords
- Galactomannan, Aspergillus spp, Bronchoalveolar Lavage, Clinical Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospital H+ QueretaroUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients who underwent galactomannan determination testing in bronchoalveolar lavage (BAL) samples
- Tests performed during the period from March 2022 to March 2026.
Key exclusion criteria (2 listed)
- Patients with galactomannan tests performed outside the established period (March 2022 to March 2026).
- Galactomannan tests performed using serum samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Invasive Aspergillosis and Association of Galactomannan Index with Clinical Outcomes
Time frame: From March 2022 to March 2026
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Aspergillosis, run by Hospital H+ Queretaro at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Invasive Aspergillosis and Association of Galactomannan Index with Clinical Outcomes (time frame: From March 2022 to March 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.