Pleural InfectionNCT06141174
Predictors of Outcome in Patients With Pleural Infection at Sohag University Hospital
An observational study of Pleural Infection, run by Sohag University at 1 site in Egypt.
Trial summary
pleural infection remains a common medical problem with significant mortality and morbidity despite a better undrstanding of the aetiology , pathophysiology and recent advances in management approaches . 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?
- disease outcome ( mortality and length of stay )
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 1 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients more than 18 years old with pleural infection
Who may be able to join
- patients more than 18 years old with pleural infection
Who cannot join
- hemothorax
- chest trauma within 3 month
- underwent thoracic surgery within 60 days
Trial locations and contacts
1 site in 1 country.
mona t hussein, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag, Sohag
Magdy M Amin, professor
About this study
pleural infection remains a common medical problem with significant mortality and morbidity despite a better undrstanding of the aetiology , pathophysiology and recent advances in management approaches .
the cornerstones of the managment op pleural infection include early identification of cases and accurate diagnosis . suitable antibiotic therapy , nutrition managment , efficient drainage of infected collection via chest tube with or without adjunctive therapies including intrapleural agents and ultimately surgical managment .
- Conditions
- Pleural Infection
- Being tested
- disease outcome ( mortality and length of stay )
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disease outcome ( mortality and length of stay )Other
insertion of intercostal tube to drain pleural collection
What is being measured
The primary outcome is the main question the study is designed to answer.
lenght of hospital stay
lenght of hospital stay since admission up to improvement
Measured: 1 month
Secondary outcomes (1)
mortality rate
mortality rate related to pleural infection
Measured: up to 30 days , 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Nov 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pleural InfectionStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Eldawwy Hashem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141174
- Sponsor's protocol ID
- Soh-med-23-10-08ms
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gould J. Pleural infection: a case where clinical improvement was misleading. BMJ Case Rep. 2013 Apr 18;2013:bcr2013008700. doi: 10.1136/bcr-2013-008700.
PubMed 23605824Rahman NM, Maskell NA, West A, Teoh R, Arnold A, Mackinlay C, Peckham D, Davies CW, Ali N, Kinnear W, Bentley A, Kahan BC, Wrightson JM, Davies HE, Hooper CE, Lee YC, Hedley EL, Crosthwaite N, Choo L, Helm EJ, Gleeson FV, Nunn AJ, Davies RJ. Intrapleural use of tissue plasminogen activator and DNase in pleural infection. N Engl J Med. 2011 Aug 11;365(6):518-26. doi: 10.1056/NEJMoa1012740.
PubMed 21830966Davies CW, Gleeson FV, Davies RJ; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of pleural infection. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii18-28. doi: 10.1136/thorax.58.suppl_2.ii18. No abstract available.
PubMed 12728147Davies HE, Davies RJ, Davies CW; BTS Pleural Disease Guideline Group. Management of pleural infection in adults: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii41-53. doi: 10.1136/thx.2010.137000. No abstract available.
PubMed 20696693
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Outcome in Patients With Pleural Infection at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06141174
- Acronym / sponsor ID
- Soh-med-23-10-08ms
- Conditions
- Pleural Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 21 Nov 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.
pleural infection remains a common medical problem with significant mortality and morbidity despite a better undrstanding of the aetiology , pathophysiology and recent advances in management approaches .
the cornerstones of the managment op pleural infection include early identification of cases and accurate diagnosis . suitable antibiotic therapy , nutrition managment , efficient drainage of infected collection via chest tube with or without adjunctive therapies including intrapleural agents and ultimately surgical managment .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients more than 18 years old with pleural infection
Key inclusion criteria (1 listed)
- patients more than 18 years old with pleural infection
Key exclusion criteria (3 listed)
- hemothorax
- chest trauma within 3 month
- underwent thoracic surgery within 60 days
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 |
|---|---|---|
| disease outcome ( mortality and length of stay )insertion of intercostal tube to drain pleural collection | Other | – |
Primary outcome
lenght of hospital stay
Time frame: 1 month
lenght of hospital stay since admission up to improvement
1 secondary outcome
mortality rate
Time frame: up to 30 days , 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Background: PubMed 23605824Gould J. Pleural infection: a case where clinical improvement was misleading. BMJ Case Rep. 2013 Apr 18;2013:bcr2013008700. doi: 10.1136/bcr-2013-008700.
- Background: PubMed 21830966Rahman NM, Maskell NA, West A, Teoh R, Arnold A, Mackinlay C, Peckham D, Davies CW, Ali N, Kinnear W, Bentley A, Kahan BC, Wrightson JM, Davies HE, Hooper CE, Lee YC, Hedley EL, Crosthwaite N, Choo L, Helm EJ, Gleeson FV, Nunn AJ, Davies RJ. Intrapleural use of tissue plasminogen activator and DNase in pleural infection. N Engl J Med. 2011 Aug 11;365(6):518-26. doi: 10.1056/NEJMoa1012740.
- Background: PubMed 12728147Davies CW, Gleeson FV, Davies RJ; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of pleural infection. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii18-28. doi: 10.1136/thorax.58.suppl_2.ii18. No abstract available.
- Background: PubMed 20696693Davies HE, Davies RJ, Davies CW; BTS Pleural Disease Guideline Group. Management of pleural infection in adults: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii41-53. doi: 10.1136/thx.2010.137000. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
mona t hussein, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Infection, run by Sohag 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 1 inclusion and 3 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 21 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact amany e hashem, resident (01145694321, amanyhashem@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lenght of hospital stay (time frame: 1 month). 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 NCT06141174, which also lists 4 linked publications.
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 21 Nov 2023.