- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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].
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Entsar Hsanen Mohamed, dr
- Número de telefone: 01019968106
- E-mail: entsar.hsanen@aun.edu.eg
Locais de estudo
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Asyut Governorate
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Asyut, Asyut Governorate, Egito, 71515
- Recrutamento
- Assiut University Gospital
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Contato:
- Entsar H Mohamed, DR
- Número de telefone: 01019968106
- E-mail: entsar.hsanen@aun.edu.eg
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
- 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
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
HAP
Diagnosis of HAP confirmed according to standard clinical, radiological, and microbiological criteria
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need for mechanical ventilation
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Prevalence of mechanical ventilation among HAP patients (v-HAP rate).
Prazo: 1 year
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1 year
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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):
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Atributos da doença
- Infecções do Trato Respiratório
- Infecções
- Doenças Respiratórias
- Doenças pulmonares
- Pneumonia
- Infecção cruzada
- Doença Iatrogênica
- Condições Patológicas, Sinais e Sintomas
- Pneumonia associada à assistência à saúde
- Terapêutica
- Gerenciamento das vias aéreas
- Ressuscitação
- Tratamento de emergência
- Terapia respiratória
- Respiração, artificial
Outros números de identificação do estudo
- Predictors of ventilated HAP
Plano para dados de participantes individuais (IPD)
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