Prevalence and Burden of Bronchiectasis in Tuberculous Pa... | NCT04085133

Studies
Prevalence and Burden of Bronchiectasis in Tuberculous Patients

NCT04085133

Sponsor

Assiut University

Status

Completed

Last Update Posted

Feb 17, 2023Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Pulmonary Tuberculoses

Interventions

Gene Xpert Chest x ray and MSCT chest

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 26, 2019Actual

Primary Completion Date

Jan 1, 2020Actual

Completion Date

Apr 1, 2020Actual

First Submitted Date

May 28, 2019

First Submission Date that Met QC Criteria

Sep 8, 2019

First Posted Date

Sep 11, 2019Actual

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

Feb 15, 2023

Last Update Posted Date

Feb 17, 2023Actual

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

Bronchiectasis was described in the early 19th century by Laennec. Bronchiectasis is a chronic condition characterized by permanent and irreversible dilatation of the bronchial airways and impairment of mucociliary transport mechanism due to repeated infection and inflammation leading to colonization of organism and pooling of the mucus in the bronchial tree

Detailed Description

The prevalence of bronchiectasis is age-related and occurs in every age group and in the pre-antibiotic era . it most often began in childhood. Recent evidence shows that bronchiectasis disproportionately affects women and older individuals and will be contributing to increase in healthcare burden.[3] International data show an increase in the prevalence of bronchiectasis over recent years.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gene Xpert Chest x ray and MSCT chest	Diagnostic Test	Sputum sample for T.B will be done using gene expert device and chest xray and high resolution ct to evaluate bronchectasis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To study prevalence of bronchiectasis in TB patients by case per year.	How many patients of TB will be diagnosed as abronchiectasis	One year

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the burden of bronchiectasis in TB patients	by frequency of need for hospital admission per year, need for outpatient clinical visits per month and frequency of need for antimicrobial therapy other than anti-tuberculous treatment per month	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1-patients were diagnosed to have tuberculosis by sputum culture and gene x pert.

2-patients were diagnosed to have bronchiectasis after lab and radiological examination as well as clinical score.

3- patients diagnosed as bronchiectasis after history of tuberculosis or anti Tuberculosis treatment with positive or negative tuberculous culture in the time of research.

Exclusion Criteria:

1-patients presented with other Pulmonary diseases. 2-Chronic liver and renal disease . 3- Lung cancer and tumors. 4- patients were previously diagnosed as bronchiectasis .

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Any tuberculosis patients admited to assuit university hospital and assuit chest hospital

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Assiut unviresty		Asyut		71511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014397	Tuberculosis, Pulmonary

Ancestor Terms

ID	Term
D014376	Tuberculosis
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided