NeuBluMul
Evaluation of an Expanded Diagnostic Strategy in Patients Aged 65 Years or Older Hospitalized With Community-Acquired Acute Respiratory Infection
Sponsor study identifier
interventional
406
1 country
1
Study Start
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 3, 2026
Actual (reported)October 20, 2026
Actual (reported)May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Total Duration of Antibiotic Therapy
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
Duration of High Impact Antibiotic Therapy
From hospital admission through 30 days after hospital discharge
Antibiotic De-escalation
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.
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.
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.
Hospital General Universitario de Elche
Elche, Alicante, 03203, Spain
Desai D, Shah AB, Dela JRC, Mugibel TA, Sumaily KM, Sabi EM, Mujamammi AH, Malafi ME, Alkaff SA, Alwahbi TA, Bahabara JO, Dahman LSB. Lung Ultrasonography Accuracy for Diagnosis of Adult Pneumonia: Systematic Review and Meta-Analysis. Adv Respir Med. 2024 Jun 4;92(3):241-253. doi: 10.3390/arm92030024.
Buchan BW, Windham S, Balada-Llasat JM, Leber A, Harrington A, Relich R, Murphy C, Dien Bard J, Naccache S, Ronen S, Hopp A, Mahmutoglu D, Faron ML, Ledeboer NA, Carroll A, Stone H, Akerele O, Everhart K, Bonwit A, Kwong C, Buckner R, Warren D, Fowler R, Chandrasekaran S, Huse H, Campeau S, Humphries R, Graue C, Huang A. Practical Comparison of the BioFire FilmArray Pneumonia Panel to Routine Diagnostic Methods and Potential Impact on Antimicrobial Stewardship in Adult Hospitalized Patients with Lower Respiratory Tract Infections. J Clin Microbiol. 2020 Jun 24;58(7):e00135-20. doi: 10.1128/JCM.00135-20. Print 2020 Jun 24.
Félix Gutiérrez Rodero, MD, PhD
Hospital General Universitario de Elche / Universidad Miguel Hernández
Mar Masiá Canuto, MD, PhD
Hospital General Universitario de Elche / Universidad Miguel Hernández
First Submitted
October 3, 2026
First Posted
October 20, 2026
Study Start
October 2026
From hospital admission through 30 days after hospital discharge
Antibiotic Escalation
From hospital admission through 30 days after hospital discharge
Pathogen Detection by Pneumonia Panel PCR
Within the first 24 hours after hospital admission
Time to Microbiological Diagnosis
From hospital admission to hospital discharge (assessed at 30 days after discharge)
Conventional diagnostic assessment and antimicrobial management according to usual clinical practice. Etiological diagnostic tests are performed at the discretion of the treating physician.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Ito A, Ito I, Inoue D, Marumo S, Ueda T, Nakagawa H, Taki M, Nakagawa A, Tatsumi S, Nishimura T, Shiota T, Ishida T. The utility of serial procalcitonin measurements in addition to pneumonia severity scores in hospitalised community-acquired pneumonia: A multicentre, prospective study. Int J Infect Dis. 2020 Mar;92:228-233. doi: 10.1016/j.ijid.2020.01.018. Epub 2020 Jan 22.
Ye X, Xiao H, Chen B, Zhang S. Accuracy of Lung Ultrasonography versus Chest Radiography for the Diagnosis of Adult Community-Acquired Pneumonia: Review of the Literature and Meta-Analysis. PLoS One. 2015 Jun 24;10(6):e0130066. doi: 10.1371/journal.pone.0130066. eCollection 2015.
Poole S, Tanner AR, Naidu VV, Borca F, Phan H, Saeed K, Grocott MPW, Dushianthan A, Moyses H, Clark TW. Molecular point-of-care testing for lower respiratory tract pathogens improves safe antibiotic de-escalation in patients with pneumonia in the ICU: Results of a randomised controlled trial. J Infect. 2022 Dec;85(6):625-633. doi: 10.1016/j.jinf.2022.09.003. Epub 2022 Sep 9.
Moradi T, Bennett N, Shemanski S, Kennedy K, Schlachter A, Boyd S. Use of Procalcitonin and a Respiratory Polymerase Chain Reaction Panel to Reduce Antibiotic Use via an Electronic Medical Record Alert. Clin Infect Dis. 2020 Oct 23;71(7):1684-1689. doi: 10.1093/cid/ciz1042.
Abelenda-Alonso G, Calatayud L, Rombauts A, Meije Y, Oriol I, Sopena N, Padulles A, Niubo J, Duarte A, Llaberia J, Aranda J, Gudiol C, Satorra P, Tebe C, Ardanuy C, Carratala J. Multiplex real-time PCR in non-invasive respiratory samples to reduce antibiotic use in community-acquired pneumonia: a randomised trial. Nat Commun. 2024 Aug 17;15(1):7098. doi: 10.1038/s41467-024-51547-8.
Serigstad S, Knoop ST, Markussen DL, Ulvestad E, Bjorneklett RO, Ebbesen MH, Kommedal O, Grewal HMS. Diagnostic utility of oropharyngeal swabs as an alternative to lower respiratory tract samples for PCR-based syndromic testing in patients with community-acquired pneumonia. J Clin Microbiol. 2023 Sep 21;61(9):e0050523. doi: 10.1128/jcm.00505-23. Epub 2023 Aug 16.
Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 20, 2026
Record last verified: 2026-10
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.
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Source: ClinicalTrials.gov.
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