Community-acquired PneumoniaNCT06097117
Role of Multiplex PCR in CAP
An observational study of Community-acquired Pneumonia, run by Assiut University.
Trial summary
1. role of multiplex PCR in early identifying bacteria in patients with lower respiratory tract infection. 2. effect of early starting targeted antibiotics on outcome Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- MultiplexPCR
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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:
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- 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%.
Who cannot join
- Patients under 18 years old. Patients who refuse to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Molecular Methods for Identifying Bacteria in Lower Respiratory Tract Specimens Among Patients With Pneumonia by Multiplex PCR
- role of multiplex PCR in early identifying bacteria in patients with lower respiratory tract infection.
- effect of early starting targeted antibiotics on outcome
Read the detailed description
Pneumonia remains a worldwide health problem with a high rate of morbidity and mortality. Identification of microbial pathogens which cause pneumonia is an important area for optimum clinical management of pneumonia patients and is a big challenge for conventional microbiological methods. The development and implementation of molecular diagnostic tests for pneumonia has been a major advance in the microbiological diagnosis of respiratory pathogens in recent years. Targeted antibiotic selection and more effective de-escalation and improved stewardship for pneumonia patients.
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.
Each PCR assay requires the presence of template DNA, primers, nucleotides, and DNA polymerase .The DNA polymerase is the key enzyme that links individual nucleotides together to form the PCR product. The nucleotides include the four bases - adenine, thymine, cytosine, and guanine (A, T, C, G) - that are found in DNA. These act as the building blocks that are used by the DNA polymerase to create the resultant PCR product. The primers in the reaction specify the exact DNA product to be amplified. The primers are short DNA fragments with a defined sequence complementary to the target DNA that is to be detected and amplified. These serve as an extension point for the DNA polymerase to build on.There are multiple advantages to PCR. First, it is a simple technique to understand and to use, a nd it produces results rapidly. It is a highly sensitive technique with the potential to produce millions to billions of copies of a specific product for sequencing, cloning, and analysis. Although PCR is a valuable technique, it does have limitations. Because PCR is a highly sensitive technique, any form of contamination of the sample by even trace amounts of DNA can produce misleading results . In addition, in order to design primers for PCR, some prior sequence data is needed. Therefore, PCR can only be used to identify the presence or absence of a known pathogen or gene
- Conditions
- Community-acquired Pneumonia
- Being tested
- MultiplexPCR
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultiplexPCRDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| one group undergoes multiplex PCR | treatment will be started according targeted antibiotics Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
detect Antimicrobial therapy duration in CAP in comparison in both groups
Antimicrobial therapy duration in patients with CAP in comparison of two groups
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Saleh Mousa Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097117
- Sponsor's protocol ID
- role of multiplex PCR in CAP
- Status last verified
- Oct 2023
- First submitted
- 1 Sep 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Methods for Identifying Bacteria in Lower Respiratory Tract Specimens Among Patients With Pneumonia by Multiplex PCR
- ClinicalTrials.gov ID
- NCT06097117
- Acronym / sponsor ID
- role of multiplex PCR in CAP
- Conditions
- Community-acquired Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- role of multiplex PCR in early identifying bacteria in patients with lower respiratory tract infection.
- effect of early starting targeted antibiotics on outcome
Detailed description
Pneumonia remains a worldwide health problem with a high rate of morbidity and mortality. Identification of microbial pathogens which cause pneumonia is an important area for optimum clinical management of pneumonia patients and is a big challenge for conventional microbiological methods. The development and implementation of molecular diagnostic tests for pneumonia has been a major advance in the microbiological diagnosis of respiratory pathogens in recent years. Targeted antibiotic selection and more effective de-escalation and improved stewardship for pneumonia patients.
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.
Each PCR assay requires the presence of template DNA, primers, nucleotides, and DNA polymerase .The DNA polymerase is the key enzyme that links individual nucleotides together to form the PCR product. The nucleotides include the four bases - adenine, thymine, cytosine, and guanine (A, T, C, G) - that are found in DNA. These act as the building blocks that are used by the DNA polymerase to create the resultant PCR product. The primers in the reaction specify the exact DNA product to be amplified. The primers are short DNA fragments with a defined sequence complementary to the target DNA that is to be detected and amplified. These serve as an extension point for the DNA polymerase to build on.There are multiple advantages to PCR. First, it is a simple technique to understand and to use, a nd it produces results rapidly. It is a highly sensitive technique with the potential to produce millions to billions of copies of a specific product for sequencing, cloning, and analysis. Although PCR is a valuable technique, it does have limitations. Because PCR is a highly sensitive technique, any form of contamination of the sample by even trace amounts of DNA can produce misleading results . In addition, in order to design primers for PCR, some prior sequence data is needed. Therefore, PCR can only be used to identify the presence or absence of a known pathogen or gene
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one group undergoes multiplex PCR | – | Diagnostic Test: MultiplexPCRtreatment will be started according targeted antibiotics |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- male and female
- Age >18 years Old
- 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:
Key exclusion criteria (1 listed)
- Patients under 18 years old. Patients who refuse to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MultiplexPCRPCR 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. | Diagnostic test | one group undergoes multiplex PCR |
Primary outcome
detect Antimicrobial therapy duration in CAP in comparison in both groups
Time frame: 1 year
Antimicrobial therapy duration in patients with CAP in comparison of two groups
detect clinical improvement in both groups
Time frame: 1 year
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- . Timsit J-F, Bassetti M, Cremer O, et al. Rationalizing antimicrobial therapy in the ICU: a narrative review. Intensive Care Med. 2019;45(2):172-89Link provided by the sponsor.
- . 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. 2019Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-acquired Pneumonia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Saleh Mousa, resident physician (01149227845, asmaa241.saleh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detect Antimicrobial therapy duration in CAP in comparison in both groups (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.