Predictors of Outcome in Patients With Pleural Infection... | NCT06141174

Studies
Predictors of Outcome in Patients With Pleural Infection at Sohag University Hospital

NCT06141174

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Nov 21, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Pleural Infection

Interventions

disease outcome ( mortality and length of stay )

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2023Actual

Primary Completion Date

May 1, 2024Estimated

Completion Date

May 1, 2024Estimated

First Submitted Date

Nov 15, 2023

First Submission Date that Met QC Criteria

Nov 20, 2023

First Posted Date

Nov 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2023

Last Update Posted Date

Nov 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amany Eldawwy Hashem, resident at chest diseases and tuberculosis, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 .

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 .

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
disease outcome ( mortality and length of stay )	Other	insertion of intercostal tube to drain pleural collection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
lenght of hospital stay	lenght of hospital stay since admission up to improvement	1 month

Secondary Outcomes

Measure	Description	Time Frame
mortality rate	mortality rate related to pleural infection	up to 30 days , 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients more than 18 years old with pleural infection

Exclusion Criteria:

hemothorax
chest trauma within 3 month
underwent thoracic surgery within 60 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients more than 18 years old with pleural infection

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
amany e hashem, resident	Contact	01145694321		amanyhashem@med.sohag.edu.eg
mona t hussein, professor	Contact	01028068879

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag university Hospital	Recruiting	Sohag		Sohag	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23605824	Background	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.
21830966	Background	Rahman 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.

Type	Date	Date Unknown
Release	Feb 8, 2026
Reset	Feb 25, 2026

ID	Term
D009026	Mortality
D007902	Length of Stay

ID	Term
D014798	Vital Statistics
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques