Antibiotic Observatory for Respiratory Diseases, Apart From Tuberculosis and Reportable Diseases (AORD)
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|ClinicalTrials.gov Identifier: NCT04482231|
Recruitment Status : Completed
First Posted : July 22, 2020
Last Update Posted : July 22, 2020
|Condition or disease|
|Antibiotic Sore Tongue|
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, pharyngitis/tonsillitis, 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 prescribed.Appropriateness 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 instructions.The MAI has been used in observational and interventional studies.Its 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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||9944 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Antibiotic Observatory for Respiratory Diseases, Apart From Tuberculosis and Reportable Diseases|
|Actual Study Start Date :||January 2, 2018|
|Actual Primary Completion Date :||August 31, 2018|
|Actual Study Completion Date :||August 31, 2018|
- Appropriateness of antibiotic prescription [ Time Frame: 1 day ]dichotomous (yes / no) criterion that characterizes appropriate or inappropriate use of antibiotics based on respiratory indication and patient profile
- inappropriatness of antibiotic prescription [ Time Frame: 1 day ]number of inappropriate antibiotic prescriptions by clinical indication
- international recommendations [ Time Frame: 1 day ]description of therapeutic strategies inconsistent with international recommendations
- patients profile with inappropriate antibiotic therapy [ Time Frame: 1 day ]profile of patients with inappropriate antibiotic therapy
- patients profile with infectious disease [ Time Frame: 1 day ]profile of patients with infectious disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04482231
|Emergency department of fattouma bourguiba university hospital|
|Monastir, Tunisia, 5020|
|Principal Investigator:||nouira semir, MD||University of Monastir|