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Clinical Trials/NCT04482231
NCT04482231
Completed
Not Applicable

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

University of Monastir1 site in 1 country9,944 target enrollmentJanuary 2, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Antibiotic Sore Tongue
Sponsor
University of Monastir
Enrollment
9944
Locations
1
Primary Endpoint
Appropriateness of antibiotic prescription
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2, 2018
End Date
August 31, 2018
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pr. Semir Nouira

professor semir nouira

University of Monastir

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • patients profile with inappropriate antibiotic therapy(1 day)
  • patients profile with infectious disease(1 day)
  • international recommendations(1 day)
  • inappropriatness of antibiotic prescription(1 day)

Study Sites (1)

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