Role of Multiplex PCR in CAP

NCT06097117 | Unknown

• 1 other identifier: role of multiplex PCR in CAP
• Study Type: observational
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.role of multiplex PCR in early identifying bacteria in patients with lower respiratory tract infection.
2. 2.effect of early starting targeted antibiotics on outcome

Conditions

Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (2)

• detect Antimicrobial therapy duration in CAP in comparison in both groups

  Antimicrobial therapy duration in patients with CAP in comparison of two groups

  1 year

• detect clinical improvement in both groups

  detection of clinical improvement in both groups (subsided of bronchial symptoms as productive cough ,colored sputum, relieve of dysnea and pleuritic chest pain , subsided of fever

  1 year

Study Arms (2)

one group undergoes multiplex PCR

treatment will be started according targeted antibiotics

Diagnostic Test: MultiplexPCR

the other group undergoes simple culture and sensitivity

empirical antibiotics will be started until results appear and according results ,treatment will be completed or shifted to another treatment or be narrowed ,later on detect outcome of both groups.

Interventions

MultiplexPCR DIAGNOSTIC_TEST

PCR is a simple, yet elegant, enzymatic assay, which allows for the amplification of a specific DNA fragment from a complex pool of DNA.. Only trace amounts of DNA are needed for PCR to generate enough copies to be analyzed using conventional laboratory methods. For this reason, PCR is a sensitive assay.

one group undergoes multiplex PCR

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with CAP will divided in two groups (1:1), one group undergoes multiplex PCR and treatment will be started according targeted antibiotics, the other group undergoes simple culture and sensitivity and empirical antibiotics will be started until results appear and according results ,treatment will be completed or shifted to another treatment or be narrowed ,later on detect outcome of both groups. Sample Size Calculation: 66 cases

You may qualify if:

• male and female
• Age \>18 years Old
• Adult patients were included if they fulfilled:
• radiographic and clinical criteria.
• Radiographic findings included chest imaging with an airspace opacity, lobar consolida-tion, or interstitial opacities
• new or worsening compared to available baseline. In addition, at least 2 of the following clinical criteria had to be fulfilled:
• reported or documented fever \> 37.5
• new worsening productive cough or increase in respiratory secretions in intubated patients
• pleuritic chest pain 4) new/worsening dyspnea or hypoxia, defined as documented blood oxygen saturation \<92%.

You may not qualify if:

• Patients under 18 years old. Patients who refuse to participate in the study

Sponsors & Collaborators

• Assiut University: lead

Related Links

• . Timsit J-F, Bassetti M, Cremer O, et al. Rationalizing antimicrobial therapy in the ICU: a narrative review. Intensive Care Med. 2019;45(2):172-89
• . Peiffer-Smadja N, Rawson TM, Ahmad R, et al. Machine learning for clinical decision support in infectious diseases: a narrative review of current applications. Clin Microbiol Infect Published online September 17. 2019

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Central Study Contacts

Asmaa Saleh Mousa, resident physician

CONTACT

01149227845; asmaa241.saleh@gmail.com

Lamia Hasan Shaaban, prof

CONTACT

01002681478; Lamiashaban@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at Chest department

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: October 24, 2023
• Study Start: November 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 24, 2023

Record last verified: 2023-10