Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection (NeuBluMul)

November 3, 2026 updated by: Santiago Lopez Gil

Evaluation of an Expanded Diagnostic Strategy in Patients Aged 65 Years or Older Hospitalized With Community-Acquired Acute Respiratory Infection

This study will evaluate whether an expanded diagnostic strategy can reduce antibiotic use in patients aged 65 years or older who are hospitalized with community-acquired acute respiratory infection, without negatively affecting clinical outcomes.

The expanded diagnostic strategy combines multiplex respiratory polymerase chain reaction (PCR), serial procalcitonin measurements, and bedside lung ultrasound. The results of these tests will be integrated to support decisions about antibiotic treatment.

The study will compare the expanded diagnostic strategy with conventional diagnostic management. The main outcome will be the total duration of antibiotic therapy. The study will also assess the use of high-impact antibiotics, microbiological diagnosis, hospital and intensive care unit stay, complications, mortality, recurrence of infection, hospital readmissions, detection of multidrug-resistant microorganisms, and antibiotic-related adverse events.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a pragmatic, controlled, open-label, cluster-randomized crossover trial conducted in two hospital wards at Hospital General Universitario de Elche, Spain. The study population will consist of patients aged 65 years or older hospitalized with community-acquired acute respiratory infection.

The two hospital wards will constitute the study clusters. During the first two-month study period, one ward will be randomly assigned to the expanded diagnostic strategy and the other to the conventional diagnostic strategy. After a two-month washout period, the ward-level strategies will be crossed over for a second two-month study period. Individual participants will receive only the diagnostic strategy assigned to their hospital ward during the corresponding study period.

The expanded diagnostic strategy will include multiplex respiratory PCR using the BIOFIRE Pneumonia Panel plus, including detection of selected antimicrobial resistance genes; bedside lung ultrasound using the BLUE protocol; and serial procalcitonin measurements. The results will be integrated into a predefined diagnostic and therapeutic algorithm to support decisions regarding antibiotic initiation, continuation, modification, de-escalation, and discontinuation.

Participants assigned to the conventional diagnostic strategy will receive usual diagnostic assessment and antimicrobial management. Etiological diagnostic tests will be performed according to routine clinical practice and at the discretion of the treating physician.

The primary objective is to determine whether the expanded diagnostic strategy reduces the total duration of antibiotic therapy compared with conventional diagnostic management. Secondary assessments will include high-impact antibiotic use, antibiotic escalation and de-escalation, microbiological diagnosis and time to diagnosis, detection of multidrug-resistant microorganisms, infectious complications, hospital and intensive care unit length of stay, intensive care unit admission, in-hospital and 30-day mortality, recurrence of infection requiring antimicrobial therapy, 30-day hospital readmission, and antibiotic-related adverse events.

An exploratory economic evaluation of the expanded diagnostic strategy is also planned from the perspective of the Spanish National Health System.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
406

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 65 years.
  • Hospital admission to the Internal Medicine or Infectious Diseases ward for a community-acquired acute respiratory infection.
  • Acute respiratory infection defined by the presence of at least two of the following criteria, with at least one being a clinical criterion:
  • Clinical criteria: new-onset cough or worsening of pre-existing cough; purulent sputum production or changes in usual sputum characteristics; new-onset dyspnea or worsening of pre-existing dyspnea; pleuritic chest pain; abnormal respiratory sounds (crackles, rhonchi, or wheezing); fever (temperature ≥ 38°C) or hypothermia (temperature < 36°C).
  • Laboratory criteria: leukocytosis (white blood cell count > 11,000/µL or neutrophil count > 8,200/µL) or C-reactive protein ≥ 20 mg/L.
  • Radiological criteria: new pulmonary infiltrate or worsening of a pre-existing pulmonary infiltrate on chest imaging.
  • No alternative diagnosis considered more likely to explain the clinical presentation, according to the treating physician.

Exclusion Criteria:

  • Charlson Comorbidity Index ≥ 5.
  • Imminent death with a life expectancy < 24 hours.
  • Admission to the intensive care unit (ICU) directly from the Emergency Department or within the first 24 hours after admission to the hospital ward.
  • Diagnosis of a solid-organ or hematologic malignancy with active oncologic treatment within the previous 3 months.
  • Immune-mediated disease treated with immunosuppressive or immunomodulatory drugs.
  • Transplant recipient.
  • Treatment with prednisone ≥ 20 mg/day (or equivalent) for ≥2 weeks.
  • Human immunodeficiency virus (HIV) infection with an absolute CD4 count < 200 cells/µL.
  • Profound neutropenia (< 100 cells/µL).
  • Refusal to participate in the study or concurrent participation in another study.
  • Previous inclusion in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Expanded Diagnostic Strategy

Participants receive an expanded diagnostic strategy in addition to conventional diagnostic assessment. The strategy includes multiplex respiratory PCR, bedside lung ultrasound, and serial procalcitonin measurements. Results are integrated into a predefined diagnostic and therapeutic algorithm to support decisions regarding antibiotic initiation, continuation, modification, de-escalation, and discontinuation.
Diagnostic test: Expanded Diagnostic Strategy

A protocolized diagnostic strategy combining multiplex respiratory PCR using the BIOFIRE Pneumonia Panel plus, bedside lung ultrasound using the BLUE protocol, and serial procalcitonin measurements. Diagnostic results are integrated into a predefined algorithm to support decisions regarding antibiotic initiation, continuation, modification, de-escalation, and discontinuation.
Active Comparator: Conventional Diagnostic Strategy

Participants receive conventional diagnostic assessment and antimicrobial management according to usual clinical practice. Etiological diagnostic tests may be performed at the discretion of the treating physician.
Diagnostic test: Conventional Diagnostic Strategy

Conventional diagnostic assessment and antimicrobial management according to usual clinical practice. Etiological diagnostic tests are performed at the discretion of the treating physician.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Duration of Antibiotic Therapy
Time Frame: From hospital admission through 30 days after hospital discharge

Total antibiotic exposure, calculated as the sum of days of therapy for all antibiotics received for the index acute respiratory infection, including antibiotic therapy administered during hospitalization and antibiotic therapy prescribed at hospital discharge. Each antibiotic received on a given calendar day contributes one day of therapy; therefore, days of concomitant antibiotic therapy are counted separately for each antibiotic.
From hospital admission through 30 days after hospital discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of High Impact Antibiotic Therapy
Time Frame: From hospital admission through 30 days after hospital discharge

Total exposure to high-impact antibiotics, calculated as the sum of days of therapy for all high-impact antibiotics received for the index acute respiratory infection. High-impact antibiotics are predefined as levofloxacin, moxifloxacin, piperacillin-tazobactam, ceftaroline, ceftobiprole, cefiderocol, cefepime, ceftazidime-avibactam, ceftolozane-tazobactam, carbapenems, vancomycin, and linezolid. Each antibiotic received on a given calendar day contributes one day of therapy; concomitant antibiotics are counted separately.
From hospital admission through 30 days after hospital discharge
Antibiotic De-escalation
Time Frame: From hospital admission through 30 days after hospital discharge

Proportion of participants in whom antibiotic therapy is de-escalated during the index hospitalization or after discharge. Antibiotic de-escalation is defined as switching from a high-impact antibiotic to a low-impact antibiotic or discontinuing antibiotic therapy, according to the predefined classification in the study protocol.
From hospital admission through 30 days after hospital discharge
Antibiotic Escalation
Time Frame: From hospital admission through 30 days after hospital discharge

Proportion of participants requiring escalation to high-impact antibiotic therapy for the index acute respiratory infection. Antibiotic escalation is defined as the need to change to an antibiotic classified as high-impact according to the predefined classification in the study protocol.
From hospital admission through 30 days after hospital discharge
Pathogen Detection by Pneumonia Panel PCR
Time Frame: Within the first 24 hours after hospital admission

Proportion of participants in whom at least one pathogen is detected by the multiplex pneumonia panel PCR performed on a respiratory sample.
Within the first 24 hours after hospital admission
Time to Microbiological Diagnosis
Time Frame: From hospital admission to hospital discharge (assessed at 30 days after discharge)

Time in hours from hospital admission to the availability of the microbiological result establishing the microbiological diagnosis.
From hospital admission to hospital discharge (assessed at 30 days after discharge)
Detection of Multidrug-Resistant Microorganisms
Time Frame: From hospital admission through 30 days after hospital discharge

Proportion of participants in whom at least one multidrug-resistant microorganism is detected in any microbiological sample. Multidrug-resistant microorganisms are defined as methicillin-resistant Staphylococcus aureus (MRSA); Enterobacterales producing extended-spectrum beta-lactamases (ESBL), AmpC beta-lactamases, or carbapenemases; Pseudomonas aeruginosa resistant to at least one antibiotic in each of the following classes: penicillins, cephalosporins, carbapenems, fluoroquinolones, and aminoglycosides; carbapenem-resistant Acinetobacter baumannii; and Stenotrophomonas maltophilia.
From hospital admission through 30 days after hospital discharge
Respiratory Infection-Related Complications
Time Frame: From hospital admission through 30 days after hospital discharge

Proportion of participants who develop at least one complication related to the index acute respiratory infection, including empyema, sepsis, lung abscess, acute respiratory distress syndrome, multiorgan failure, or venous thromboembolism.
From hospital admission through 30 days after hospital discharge
Hospital Length of Stay
Time Frame: From hospital admission to hospital discharge (assessed at 30 days after discharge)

Total number of days from hospital admission to hospital discharge.
From hospital admission to hospital discharge (assessed at 30 days after discharge)
Intensive Care Unit Admission
Time Frame: From hospital admission to hospital discharge (assessed at 30 days after discharge)

Proportion of participants requiring admission to the intensive care unit (ICU) during the index hospitalization.
From hospital admission to hospital discharge (assessed at 30 days after discharge)
Intensive Care Unit Length of Stay
Time Frame: From hospital admission to hospital discharge (assessed at 30 days after discharge)

Total number of days spent in the intensive care unit (ICU) during the index hospitalization among participants requiring ICU admission.
From hospital admission to hospital discharge (assessed at 30 days after discharge)
In-Hospital Mortality
Time Frame: From hospital admission to hospital discharge (assessed at 30 days after discharge)

Proportion of participants who die from any cause during the index hospitalization.
From hospital admission to hospital discharge (assessed at 30 days after discharge)
30-Day Mortality After Hospital Discharge
Time Frame: Within 30 days after hospital discharge

Proportion of participants who die from any cause within 30 days after hospital discharge.
Within 30 days after hospital discharge
Recurrence of Respiratory Infection Requiring Antibiotic Therapy
Time Frame: From hospital admission through 30 days after hospital discharge

Proportion of participants who develop a new episode of respiratory infection requiring a new course of antibiotic therapy during the index hospitalization or within 30 days after hospital discharge.
From hospital admission through 30 days after hospital discharge
30-Day Hospital Readmission
Time Frame: Within 30 days after hospital discharge

Proportion of participants requiring hospital readmission for any cause within 30 days after hospital discharge.
Within 30 days after hospital discharge
Antibiotic-Related Adverse Events
Time Frame: From hospital admission through 30 days after hospital discharge

Proportion of participants who experience at least one adverse event considered related to antibiotic therapy, including phlebitis and Clostridioides difficile infection.
From hospital admission through 30 days after hospital discharge
Healthcare Costs
Time Frame: From hospital admission through 30 days after hospital discharge

Total direct healthcare costs associated with antimicrobial therapy and the diagnostic procedures included in the expanded diagnostic strategy. Costs will include antimicrobial therapy, serial procalcitonin measurements, bedside lung ultrasound, and multiplex pneumonia panel PCR testing.
From hospital admission through 30 days after hospital discharge
Cramér's V Coefficient for Association Between Lung Ultrasound BLUE Profile and Microbiological Diagnostic Category
Time Frame: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge

The association between the presence or absence of a pneumonia-compatible lung ultrasound BLUE profile (ultrasound profile present/absent) and microbiological diagnostic category (bacterial, viral, mixed bacterial-viral, or no microbiological diagnosis) will be measured using Cramér's V coefficient. Lung ultrasound will be performed according to the BLUE protocol, and microbiological categories will be determined using tests performed during the index hospitalization. Cramér's V will be calculated from a 2 × 4 contingency table, yielding a single unitless numerical value ranging from 0 (no association) to 1 (maximum association). Participants with insufficient microbiological data will be excluded. Diagnostic category distributions according to ultrasound findings will also be reported descriptively.
During the index hospitalization, with final outcome assessment at 30 days after hospital discharge
Cramér's V Coefficient for the Association Between PLAPS and Microbiological Diagnostic Category
Time Frame: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge

The association between the presence or absence of posterolateral alveolar and/or pleural syndrome (PLAPS) on lung ultrasound (PLAPS present/absent) and microbiological diagnostic category (bacterial, viral, mixed bacterial-viral, or no microbiological diagnosis) will be measured using Cramér's V coefficient. Lung ultrasound will be performed according to the BLUE protocol, and microbiological categories will be determined using tests performed during the index hospitalization. Cramér's V will be calculated from a 2 × 4 contingency table, yielding a single unitless numerical value ranging from 0 (no association) to 1 (maximum association). Participants with insufficient microbiological data will be excluded. Diagnostic category distributions according to ultrasound findings will also be reported descriptively.
During the index hospitalization, with final outcome assessment at 30 days after hospital discharge
Cramér's V Coefficient for the Association Between B' Profile and Microbiological Diagnostic Category
Time Frame: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge

The association between the presence or absence of a B' lung ultrasound profile (B' profile present/absent) and microbiological diagnostic category (bacterial, viral, mixed bacterial-viral, or no microbiological diagnosis) will be measured using Cramér's V coefficient. Lung ultrasound will be performed according to the BLUE protocol, and microbiological categories will be determined using tests performed during the index hospitalization. Cramér's V will be calculated from a 2 × 4 contingency table, yielding a single unitless numerical value ranging from 0 (no association) to 1 (maximum association). Participants with insufficient microbiological data will be excluded. Diagnostic category distributions according to ultrasound findings will also be reported descriptively.
During the index hospitalization, with final outcome assessment at 30 days after hospital discharge
Cramér's V Coefficient for the Association Between A/B Profile and Microbiological Diagnostic Category
Time Frame: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge

The association between the presence or absence of an A/B lung ultrasound profile (A/B profile present/absent) and microbiological diagnostic category (bacterial, viral, mixed bacterial-viral, or no microbiological diagnosis) will be measured using Cramér's V coefficient. Lung ultrasound will be performed according to the BLUE protocol, and microbiological categories will be determined using tests performed during the index hospitalization. Cramér's V will be calculated from a 2 × 4 contingency table, yielding a single unitless numerical value ranging from 0 (no association) to 1 (maximum association). Participants with insufficient microbiological data will be excluded. Diagnostic category distributions according to ultrasound findings will also be reported descriptively.
During the index hospitalization, with final outcome assessment at 30 days after hospital discharge
Cramér's V Coefficient for the Association Between C Profile and Microbiological Diagnostic Category
Time Frame: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge

The association between the presence or absence of a C lung ultrasound profile (C profile present/absent) and microbiological diagnostic category (bacterial, viral, mixed bacterial-viral, or no microbiological diagnosis) will be measured using Cramér's V coefficient. Lung ultrasound will be performed according to the BLUE protocol, and microbiological categories will be determined using tests performed during the index hospitalization. Cramér's V will be calculated from a 2 × 4 contingency table, yielding a single unitless numerical value ranging from 0 (no association) to 1 (maximum association). Participants with insufficient microbiological data will be excluded. Diagnostic category distributions according to ultrasound findings will also be reported descriptively.
During the index hospitalization, with final outcome assessment at 30 days after hospital discharge
Cramér's V Coefficient for the Association Between Pleural Effusion and Microbiological Diagnostic Category
Time Frame: During the index hospitalization, with final outcome assessment at 30 days after hospital discharge

The association between the presence or absence of pleural effusion on lung ultrasound (pleural effusion present/absent) and microbiological diagnostic category (bacterial, viral, mixed bacterial-viral, or no microbiological diagnosis) will be measured using Cramér's V coefficient. Lung ultrasound will be performed according to the BLUE protocol, and microbiological categories will be determined using tests performed during the index hospitalization. Cramér's V will be calculated from a 2 × 4 contingency table, yielding a single unitless numerical value ranging from 0 (no association) to 1 (maximum association). Participants with insufficient microbiological data will be excluded. Diagnostic category distributions according to ultrasound findings will also be reported descriptively.
During the index hospitalization, with final outcome assessment at 30 days after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Santiago Lopez Gil

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mar Masiá Canuto, MD, PhD, Hospital General Universitario de Elche / Universidad Miguel Hernández
  • Study Chair: Félix Gutiérrez Rodero, MD, PhD, Hospital General Universitario de Elche / Universidad Miguel Hernández

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025.106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data are not planned to be shared because a formal data-sharing plan has not been established for this study. Any future requests for data access would be evaluated in accordance with institutional policies, ethical requirements, and applicable data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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