Pleural InfectionFLAG-PINSNCT05702580
Fluid Agitation Microbiologic Yield In Pleural Infection Feasibility Study
A study testing Agitated Pleural Fluid Thoracentesis in people with Pleural Infection, run by Alexandria University at 1 site in Egypt.
Trial summary
The goal of this study is to compare the microbiologic diagnostic yield of pre-aspiration agitated pleural fluid versus that of conventionally aspirated fluid in pleural infection patients. The main question it aims to answer is, whether fluid agitation helps to increase the microbiological yield. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Infection
- What is being tested?
- Agitated Pleural Fluid Thoracentesis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to 29 Jan 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old
- Pleural infection based on clinical presentation, imaging or laboratory investigations and pleural fluid examination showing glucose < 40 mg/dL or pH <7.2 with lower respiratory infection or pus on aspiration
- At least a moderate amount of pleural fluid collection (2 or more intercostal spaces on thoracic ultrasound)
Who cannot join
- Minimal - mild pleural fluid deemed unsuitable for aspiration and agitation
- Hemodynamic instability
- Uncorrected coagulopathy
- Transudative or exudative lymphocytic pleural effusion on biochemical analysis
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Chest Diseases Department, Alexandria University Faculty of Medicine
Alexandria
About this study
Official title: Pleural Fluid Agitation For Improving The Microbiologic Diagnostic Yield In Pleural Infection - A Comparative Feasibility Study
The goal of this study is to compare the microbiologic diagnostic yield of pre-aspiration agitated pleural fluid versus that of conventionally aspirated fluid in pleural infection patients. The main question it aims to answer is, whether fluid agitation helps to increase the microbiological yield.
Read the detailed description
In pleural infection, It is suggested that the bacteria being diagnostically targeted, might more likely be residing on the pleural surface with a better blood supply and nutrition rather than being planktonic in the acidic, glucose deficient pleural fluid. The investigators thus hypothesize that an agitation of the pleural fluid prior to sample aspiration would aid in achieving a better cellular representation of the pleural space. This could have the effect of washing bacterial cells off the pleural surface as well as moving sedimented cells in the aspirated sample. This study aims to investigate whether an increase in the microbiological yield for infected pleural fluid could be achieved by a pre-aspiration agitation of the pleural fluid which would have a positive effect on management and eventual patient outcomes. Adult participants with pleural infection will undergo thoracentesis via both the standard and agitated fluid techniques guided by thoracic ultrasound. Microbiological yields will be compared.
- Conditions
- Pleural Infection
- Being tested
- Agitated Pleural Fluid Thoracentesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agitated Pleural Fluid ThoracentesisProcedure or surgery
Using a 16-18 gauge cannula, a standard thoracentesis will be performed then a sample of pleural fluid will be aspirated and rapidly flushed into the pleural space and redrawn again for a few cycles before a sample is finally drawn into the collection syringe
| Study group | Role | What they receive |
|---|---|---|
| Standard thoracentesis followed by pre-aspiration fluid agitation | Experimental | Participants will undergo the standard thoracentesis followed by the experimental pre-aspiration fluid agitation technique Receives: Procedure: Agitated Pleural Fluid Thoracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of the microbiologic analysis
Percentage of samples with a positive microbiologic result among both aspiration techniques
Measured: results within 1 week of sampling
Secondary outcomes (5)
LDH level difference between both aspiration methods
Difference in LDH levels in the aspirated fluid via both techniques
Measured: results within 1 day of sampling
Glucose level difference between both aspiration methods
Difference in glucose levels in the aspirated fluid via both techniques
Measured: results within 1 day of sampling
Protein level difference between both aspiration methods
Difference in protein levels in the aspirated fluid via both techniques
Measured: results within 1 day of sampling
Neutrophilic count difference between both aspiration methods
Difference in neutrophilic count in the aspirated fluid via both techniques
Measured: results within 1 day of sampling
Lymphocytic count difference between both aspiration methods
Difference in lymphocytic count in the aspirated fluid via both techniques
Measured: results within 1 day of sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start15 Dec 2022
- Primary completion29 Jan 2024
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pleural InfectionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will undergo both thoracentesis techniques; the standard and the experimental pre-aspiration agitated fluid techniques
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Salama Sadaka, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702580
- Sponsor's protocol ID
- 0107486
- Acronym
- FLAG-PINS
- Status last verified
- Jul 2024
- First submitted
- 23 Dec 2022
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sadaka A, Said R, Ashmawy H, Okasha H, Gharraf H. Pleural fluid agitation for improving the microbiologic diagnostic yield in pleural infection: a feasibility study. Respir Res. 2025 Apr 18;26(1):154. doi: 10.1186/s12931-025-03208-7.
PubMed 40251602
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pleural Fluid Agitation For Improving The Microbiologic Diagnostic Yield In Pleural Infection - A Comparative Feasibility Study
- ClinicalTrials.gov ID
- NCT05702580
- Acronym / sponsor ID
- FLAG-PINS / 0107486
- Conditions
- Pleural Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 27 Jan 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.
The goal of this study is to compare the microbiologic diagnostic yield of pre-aspiration agitated pleural fluid versus that of conventionally aspirated fluid in pleural infection patients. The main question it aims to answer is, whether fluid agitation helps to increase the microbiological yield.
Detailed description
In pleural infection, It is suggested that the bacteria being diagnostically targeted, might more likely be residing on the pleural surface with a better blood supply and nutrition rather than being planktonic in the acidic, glucose deficient pleural fluid. The investigators thus hypothesize that an agitation of the pleural fluid prior to sample aspiration would aid in achieving a better cellular representation of the pleural space. This could have the effect of washing bacterial cells off the pleural surface as well as moving sedimented cells in the aspirated sample. This study aims to investigate whether an increase in the microbiological yield for infected pleural fluid could be achieved by a pre-aspiration agitation of the pleural fluid which would have a positive effect on management and eventual patient outcomes. Adult participants with pleural infection will undergo thoracentesis via both the standard and agitated fluid techniques guided by thoracic ultrasound. Microbiological yields will be compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo both thoracentesis techniques; the standard and the experimental pre-aspiration agitated fluid techniques
| Arm | Type | Receives |
|---|---|---|
| Standard thoracentesis followed by pre-aspiration fluid agitation | Experimental | Procedure: Agitated Pleural Fluid ThoracentesisParticipants will undergo the standard thoracentesis followed by the experimental pre-aspiration fluid agitation technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years old
- Pleural infection based on clinical presentation, imaging or laboratory investigations and pleural fluid examination showing glucose < 40 mg/dL or pH <7.2 with lower respiratory infection or pus on aspiration
- At least a moderate amount of pleural fluid collection (2 or more intercostal spaces on thoracic ultrasound)
Key exclusion criteria (4 listed)
- Minimal - mild pleural fluid deemed unsuitable for aspiration and agitation
- Hemodynamic instability
- Uncorrected coagulopathy
- Transudative or exudative lymphocytic pleural effusion on biochemical analysis
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 |
|---|---|---|
| Agitated Pleural Fluid ThoracentesisUsing a 16-18 gauge cannula, a standard thoracentesis will be performed then a sample of pleural fluid will be aspirated and rapidly flushed into the pleural space and redrawn again for a few cycles before a sample is finally drawn into the collection syringe | Procedure or surgery | Standard thoracentesis followed by pre-aspiration fluid agitation |
Primary outcome
Diagnostic yield of the microbiologic analysis
Time frame: results within 1 week of sampling
Percentage of samples with a positive microbiologic result among both aspiration techniques
5 secondary outcomes
LDH level difference between both aspiration methods
Time frame: results within 1 day of sampling
Glucose level difference between both aspiration methods
Time frame: results within 1 day of sampling
Protein level difference between both aspiration methods
Time frame: results within 1 day of sampling
Neutrophilic count difference between both aspiration methods
Time frame: results within 1 day of sampling
Lymphocytic count difference between both aspiration methods
Time frame: results within 1 day of sampling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Derived from this study: PubMed 40251602Sadaka A, Said R, Ashmawy H, Okasha H, Gharraf H. Pleural fluid agitation for improving the microbiologic diagnostic yield in pleural infection: a feasibility study. Respir Res. 2025 Apr 18;26(1):154. doi: 10.1186/s12931-025-03208-7.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agitated Pleural Fluid Thoracentesis in people with Pleural Infection, run by Alexandria University at 1 site in Egypt.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of the microbiologic analysis (time frame: results within 1 week of sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05702580, which also lists 1 linked publication.
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 23 Jul 2024.