Clinical trial NCT04482231: Antibiotic Observatory for Respiratory Diseases, Apart From Tuberculosis and Reportable Diseases
Official title: Antibiotic Observatory for Respiratory Diseases, Apart From Tuberculosis and Reportable Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antibiotic Sore Tongue
Keywords: antiobiotic,
respiratory tract infections
appropriateness
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 9944
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The protocol includes the demographics, history, and the symptomatology at inclusion. After the diagnosis retained by the doctor is noted and 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.If a patient is on multiple drugs, this test can be repeated for each drug.

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.

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

Primary outcomes:
measure: Appropriateness of antibiotic prescription
timeFrame: 1 day
Secondary outcomes:
measure: inappropriatness of antibiotic prescription
timeFrame: 1 day
measure: international recommendations
timeFrame: 1 day
measure: patients profile with inappropriate antibiotic therapy
timeFrame: 1 day
measure: patients profile with infectious disease
timeFrame: 1 day
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Emergency department of fattouma bourguiba university hospital
Study officials:
affiliation: University of Monastir
name: nouira semir, MD
role: PRINCIPAL_INVESTIGATOR
References: