Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04482231
Status:
COMPLETED
Last Update Posted:
2020-07-22
First Post:
2020-07-17
Brief Title:
Antibiotic Observatory for Respiratory Diseases Apart From Tuberculosis and Reportable Diseases
Sponsor:
University of Monastir
Organization:
University of Monastir
Study Overview
Official Title:
Antibiotic Observatory for Respiratory Diseases Apart From Tuberculosis and Reportable Diseases
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AORD
Brief Summary:
the study aimed to determine the distribution of respiratory infections in Tunisian population and evaluate the frequency of antibiotics prescribed according to current international recommendations
Detailed Description:
It is an observational cross-sectional multicenter national clinical study The study was carried out from January 2018 to August 2018 in Tunisian population involving 57 primary care outpatient centers and 6 emergency departments from the 24 departments of the country
We included all patients with lower and upper respiratory tract infections RTIs who have recieved antibiotic treatment
Lower respiratory tract infection LRTI include pneumonia and acute bronchitis
Acute upper respiratory tract infection URTIs include rhinitis pharyngitistonsillitis and laryngitis Rhinitis also known as coryza is irritation and inflammation of the mucous membrane inside the nose
The protocol of our study includes the demographic characteristics and the history of the sample as well as the symptomatology at inclusion The data from the clinical examination were reported by the investigating doctor After the diagnosis retained by the doctor is noted with the management of the patient which includes additional explorations if they have been requested Finally the investigating doctor specifies the antibiotic therapy prescribedAppropriateness of antibiotic prescription was assessed in patients managed in the EDs We used the MAI score medication appropriateness index wich includes 10 criteria For each criterion the evaluator rates whether the medication is appropriate marginally appropriate or inappropriate Support is provided through explicit definitions and instructionsThe MAI has been used in observational and interventional studiesIts feasibility content validity predictive validity and reliability have been demonstrated in ambulatory settings The maximum score is 20 which translates into maximum inappropriateness If a patient is on multiple drugs this test can be repeated for each drug in order to determine a total MAI score
We included all patients with lower and upper respiratory tract infections RTIs who have recieved antibiotic treatment
Lower respiratory tract infection LRTI include pneumonia and acute bronchitis
Acute upper respiratory tract infection URTIs include rhinitis pharyngitistonsillitis and laryngitis Rhinitis also known as coryza is irritation and inflammation of the mucous membrane inside the nose
The protocol of our study includes the demographic characteristics and the history of the sample as well as the symptomatology at inclusion The data from the clinical examination were reported by the investigating doctor After the diagnosis retained by the doctor is noted with the management of the patient which includes additional explorations if they have been requested Finally the investigating doctor specifies the antibiotic therapy prescribedAppropriateness of antibiotic prescription was assessed in patients managed in the EDs We used the MAI score medication appropriateness index wich includes 10 criteria For each criterion the evaluator rates whether the medication is appropriate marginally appropriate or inappropriate Support is provided through explicit definitions and instructionsThe MAI has been used in observational and interventional studiesIts feasibility content validity predictive validity and reliability have been demonstrated in ambulatory settings The maximum score is 20 which translates into maximum inappropriateness If a patient is on multiple drugs this test can be repeated for each drug in order to determine a total MAI score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None