NCT04482231

Antibiotic Observatory for Respiratory Diseases, Apart From Tuberculosis and Reportable Diseases

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9,944 (actual)
• Sponsor: University of Monastir · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: —

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, 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.

Conditions

• Antibiotic Sore Tongue

Timeline

• Start date: 2018-01-02
• Primary completion: 2018-08-31
• Completion: 2018-08-31
• First posted: 2020-07-22
• Last updated: 2020-07-22

Locations

1 site across 1 country: Tunisia