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

Completed

• Conditions: Antibiotic Sore Tongue

• Registration Number: NCT04482231
• Lead Sponsor: University of Monastir

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, 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 Timeline

• Study Start: 2018-01-02
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2020-07
• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-17
• Last Update Submitted: 2020-07-17
• Study First Posted: 2020-07-22
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9944

Inclusion Criteria

• patients with lower and upper RTIs who recieved antibiotic treatment.

Exclusion Criteria

• not obtained informed consent, specific respiratory infection such as tuberculosis, life-threatening emergency necessitating hospitalization or non-probabilistic antibiotic therapy and contraindication to antibiotic use

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Appropriateness of antibiotic prescription	1 day	dichotomous (yes / no) criterion that characterizes appropriate or inappropriate use of antibiotics based on respiratory indication and patient profile

Secondary Outcome Measures

Name	Time	Method
patients profile with inappropriate antibiotic therapy	1 day	profile of patients with inappropriate antibiotic therapy
patients profile with infectious disease	1 day	profile of patients with infectious disease
international recommendations	1 day	description of therapeutic strategies inconsistent with international recommendations
inappropriatness of antibiotic prescription	1 day	number of inappropriate antibiotic prescriptions by clinical indication

Trial Locations

Locations (1)

Emergency department of fattouma bourguiba university hospital; 🇹🇳 Monastir, Tunisia