- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07667582
Predictors and Outcomes of Ventilated Hospital-acquired Pneumonia
Hospital-acquired pneumonia (HAP) is defined as an infection of the pulmonary parenchyma that develops in patients admitted to hospital for more than 48 hours and that was not incubating at the time of admission. It represents one of the most common and serious nosocomial infections, associated with significant morbidity, prolonged hospitalisation, and increased mortality in critically ill patients.
The aetiology of HAP is primarily driven by micro-aspiration of bacteria colonising the oropharynx and upper gastrointestinal tract. Pathogen distribution is shaped by the duration of hospitalisation, prior antibiotic exposure, local epidemiology, and patient characteristics. Multidrug-resistant (MDR) organisms are particularly prevalent in patients with prolonged inpatient stay and intensive care unit (ICU) admission, as critically ill patients become rapidly colonised with nosocomial pathogens.
Ventilator-associated pneumonia (VAP), a subgroup of nosocomial pneumonia, occurs in patients requiring tracheal intubation and mechanical ventilation for at least 48 hours. A clinically important and increasingly recognised entity is ventilated HAP (v-HAP), defined as HAP that subsequently requires tracheal intubation and mechanical ventilation. Emerging evidence indicates that v-HAP carries the highest mortality among nosocomial pneumonia subtypes in ICU patients - exceeding VAP - while non-ventilated ICU-acquired HAP carries the lowest mortality.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
All subjects will be subjected to Complete history taking including demographic characteristics, diagnosis on admission to hospital, previous antibiotic treatment in the last 90 days, antibiotics upon which HAP developed, antibiotics described for HAP treatment, hospital stay before diagnosis of hospital-acquired pneumonia and before ICU admission, steroid use, inhalation antibiotic use, length of ICU stay, length of hospital stay, chronic underlying diseases,and APACHE II score. Vital signs, complete lab investigation sputum and blood cultures, Imaging, and arterial blood gases will be collected as soon as HAP diagnosis is settled and the following indices will be recorded
- CURB-65 and CRB-65 scores: The score is an acronym for each of the risk factors measured. Each risk factor scores one point, for a maximum score of 5: Confusion of new onset, Urea > 7 mmol/l (Blood Urea Nitrogen >19), Respiratory rate of 30 breaths per minute or greater, Blood pressure less than 90 mmHg systolic or diastolic blood pressure 60 mmHg or less and Age 65 or older [4].
- SMART-COP and SMRT-CO: The score is also an acronym for each of the risk factors measured; Systolic blood pressure (<90 mmHg, 2 points); Multilobar chest radiography involvement (1 point); low Albumin level (<3.5 g/dl, 1 point); high respiratory Rate (≤50 years: ≥25 br/min,>50 years: ≥30 br/min; 1 point); Tachycardia (≥125 bpm; 1 point); Confusion (new onset; 1 point); poor Oxygenation (≤50 years: PaO2 < 70 mmHg or O2 saturation ≤ 93%,>50 years: PaO2 <60 mmHg or O2 saturation <90%; 2 points); and low arterial PH (<7.35; 2 points)[5].
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Entsar Hsanen Mohamed, dr
- Telefonnummer: 01019968106
- E-post: entsar.hsanen@aun.edu.eg
Studieorter
-
-
Asyut Governorate
-
Asyut, Asyut Governorate, Egypten, 71515
- Rekrytering
- Assiut University Gospital
-
Kontakt:
- Entsar H Mohamed, DR
- Telefonnummer: 01019968106
- E-post: entsar.hsanen@aun.edu.eg
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
- Adult patients (age ≥18 years) admitted to the Chest Department or Respiratory ICU, Assiut University Hospitals
- Diagnosis of HAP confirmed according to standard clinical, radiological, and microbiological criteria
- Hospital admission for more than 48 hours prior to pneumonia onset
- Ability to provide informed consent
Beskrivning
Inclusion Criteria:
All patients diagnosed with HAP in the chest department, Assiut University
Exclusion Criteria:
- Post operative patients
- Tracheostomized patients
- Comatosed patient since admission
- Suspected aspiration
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
HAP
Diagnosis of HAP confirmed according to standard clinical, radiological, and microbiological criteria
|
need for mechanical ventilation
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Prevalence of mechanical ventilation among HAP patients (v-HAP rate).
Tidsram: 1 year
|
1 year
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- 1-Miron M., Blaj M., Ristescu A. I., et al. Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia: A Literature Review. Microorganisms 2024 , 12(1), 213. 2-Szychowiak P., Villageois-Tran K. The role of the microbiota in the management of intensive care patients. Annals of intensive care2022, 12(1), 3. 3-Howroyd F., Chacko C., MacDuff A., et al Ventilator-associated pneumonia: pathobiological heterogeneity and diagnostic challenges. Nature communications 2024, 15(1), 6447. 4-Bradley J, Sbaih N, Chandler TR, et al. Pneumonia Severity Index and CURB-65 Score Are Good Predictors of Mortality in Hospitalized Patients with SARS-CoV-2 Community-Acquired Pneumonia. Chest. 2022 Apr;161(4):927-936. 5-Al-Badawy T. H., Abouelela A. M., & Kawi, M. A. G. A. Predictive value of different scoring systems for critically ill patients with hospital-acquired pneumonia. Egyptian Journal of Chest Diseases and Tuberculosis 2016, 65(4), 757-763. 6-Metlay J. P., Waterer G. W., Long A. C., et al. Diagnosis and treatment of adults with community-acquired pneumonia. An official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America. American journal of respiratory and critical care medicine 2019, 200(7), e45-e67. 7-Zhang S, Zhang K, Yu Y, et al. A new prediction model for assessing the clinical outcomes of ICU patients with community-acquired pneumonia: a decision tree analysis. Ann Med. 2019 Feb;51(1):41-50. 8-Reyes LF, Bastidas AR, Quintero ET,et al. Performance of the CORB (Confusion, Oxygenation, Respiratory Rate, and Blood Pressure) Scale for the Prediction of Clinical Outcomes in Pneumonia. Can Respir J. 2022 Jun 3;2022:4493777. 9-Brown SM, Dean NC. Defining and predicting severe community-acquired pneumonia. Curr Opin Infect Dis. 2010 Apr;23(2):158-64. 10-Kaya AE, Ozkan S, Usul E, et al. Comparison of pneumonia severity scores for patients diagnosed with pneumonia in emergency department. Indian J Med Res. 2020 Oct;152(4):
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Sjukdomsegenskaper
- Luftvägsinfektioner
- Infektioner
- Luftvägssjukdomar
- Lungsjukdomar
- Lunginflammation
- Korsinfektion
- Iatrogen sjukdom
- Patologiska tillstånd, tecken och symtom
- Sjukvårdsrelaterad lunginflammation
- Terapeutik
- Luftvägshantering
- Återupplivning
- Akutsjukvård
- Andningsterapi
- Andning, konstgjord
Andra studie-ID-nummer
- Predictors of ventilated HAP
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .