Clinical trial NCT06259110: Community-Acquired Pneumonia Diagnosis Through Integrating Novel Microbiological Techniques.
Official title: Revolutionizing Community-Acquired Pneumonia Diagnosis Through Integrating Novel Microbiological Techniques for Enhanced Precision
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Community-acquired Pneumonia
Keywords: Microbiological techniques
Multiplex PCR
Community-acquired Pneumonia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinical diagnosis of pneumonia who acquire infection outside hospital setting

Brief summary: To evaluate novel microbiological techniques for enhanced Pathogen Identification, assess the speed and efficiency of the integrated approach in providing timely diagnostic results, aiming to reduce the turnaround time for CAP diagnosis and subsequently improve patient outcomes and evaluate the clinical impact of enhanced precision in CAP diagnosis on treatment decisions, including the potential for targeted and more effective antimicrobial therapy based on accurate pathogen identification.

Detailed description: Community-acquired pneumonia (CAP) is the term used to describe an acute infection of the lungs that develops outside the hospital setting in a patient who has not been recently hospitalized.

Community-acquired pneumonia (CAP) is one of the most common infectious diseases and is a significant cause of mortality and morbidity globally despite preventative measures aimed at combating CAP.

These measures include pneumococcal vaccination of at-risk groups, yearly vaccinations for seasonal influenza viruses and since 2021, SARS-CoV-2 vaccination.

Understanding the etiology of CAP is crucial for accurate empirical antibiotic treatment, updating treatment guidelines, and future vaccine cost-benefit analyses. Currently, microbiological testing for CAP patients does not identify the etiology of most cases.

In contrast, molecular biology techniques, are rapid and sensitive for the diagnosis of pathogens. Furthermore, a multitude of nascent technologies, including multiplex real-time PCR; that detect multiple respiratory pathogens including both bacteria and viruses from a single respiratory tract sample and microarray methodologies, have become accessible for employment in clinical settings.

Improved diagnostics may change the management of CAP infections ,prompt identification of the appropriate organism would allow antibiotic de-escalation, which would decrease cost, adverse drug effects and antibiotic resistance pressure. These clinical interventions potentially translate to a reduced length of stay and financial savings for the patient, as well as an improved therapeutic outcome.

Eligibility criteria: Inclusion Criteria:

* All patients with clinical diagnosis of pneumonia among both sexes
* Age \>18 years Old.

Exclusion Criteria:

* Age \<18 years old.
* Patients who refuse to participate in the study.
* patient who acquire infection after hospital admission within 48 hours.

Primary outcomes:
measure: . Evaluation of Novel Microbiological Techniques
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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