Trial · NCT07883902
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Duration of Antibiotic Therapy | 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. |
| Secondary | Duration of High Impact Antibiotic Therapy | 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. |
| Secondary | Antibiotic De-escalation | 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. |
| Secondary | Antibiotic Escalation | 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. |
| Secondary | Pathogen Detection by Pneumonia Panel PCR | 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. |
| Secondary | Time to Microbiological Diagnosis | 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. |
| Secondary | Detection of Multidrug-Resistant Microorganisms | 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. |
| Secondary | Respiratory Infection-Related Complications | 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. |
| Secondary | Hospital Length of Stay | From hospital admission to hospital discharge (assessed at 30 days after discharge) | Total number of days from hospital admission to hospital discharge. |
| Secondary | Intensive Care Unit Admission | 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. |
| Secondary | Intensive Care Unit Length of Stay | 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. |
| Secondary | In-Hospital Mortality | From hospital admission to hospital discharge (assessed at 30 days after discharge) | Proportion of participants who die from any cause during the index hospitalization. |
| Secondary | 30-Day Mortality After Hospital Discharge | Within 30 days after hospital discharge | Proportion of participants who die from any cause within 30 days after hospital discharge. |
| Secondary | Recurrence of Respiratory Infection Requiring Antibiotic Therapy | 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. |
| Secondary | 30-Day Hospital Readmission | Within 30 days after hospital discharge | Proportion of participants requiring hospital readmission for any cause within 30 days after hospital discharge. |
| Secondary | Antibiotic-Related Adverse Events | 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. |
| Secondary | Healthcare Costs | 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. |
| Secondary | Cramér's V Coefficient for Association Between Lung Ultrasound BLUE Profile and Microbiological Diagnostic Category | 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. |
| Secondary | Cramér's V Coefficient for the Association Between PLAPS and Microbiological Diagnostic Category | 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. |
| Secondary | Cramér's V Coefficient for the Association Between B' Profile and Microbiological Diagnostic Category | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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