NCT07667582

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jun 2026Jun 2027

Study Start

First participant enrolled

June 1, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 18, 2026

Last Update Submit

June 24, 2026

Conditions

Keywords

HAPventilated HAP

Outcome Measures

Primary Outcomes (1)

  • Prevalence of mechanical ventilation among HAP patients (v-HAP rate).

    1 year

Study Arms (1)

HAP

Diagnosis of HAP confirmed according to standard clinical, radiological, and microbiological criteria

Behavioral: mechanical ventilation (MV)

Interventions

need for mechanical ventilation

HAP

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* 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

You may qualify if:

  • All patients diagnosed with HAP in the chest department, Assiut University

You may not qualify if:

  • Post operative patients
  • Tracheostomized patients
  • Comatosed patient since admission
  • Suspected aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Gospital

Asyut, Asyut Governorate, 71515, Egypt

RECRUITING

Related Publications (1)

  • 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):

    BACKGROUND

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Cross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Central Study Contacts

Entsar Hsanen Mohamed, dr

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

June 18, 2026

First Posted

June 25, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

June 25, 2026

Record last verified: 2026-06

Locations