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

Antibiotic Sore Tongue Clinical Trial

— AORD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04482231
• Other study ID #: BAROMETRE
• Status: Completed
• Start date: January 2, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: July 2020
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9944
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Sore Tongue
• Respiration Disorders
• Respiratory Tract Diseases
• Tuberculosis

Locations

Country	Name	City	State
Tunisia	Emergency department of fattouma bourguiba university hospital	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appropriateness of antibiotic prescription	dichotomous (yes / no) criterion that characterizes appropriate or inappropriate use of antibiotics based on respiratory indication and patient profile	1 day
Secondary	inappropriatness of antibiotic prescription	number of inappropriate antibiotic prescriptions by clinical indication	1 day
Secondary	international recommendations	description of therapeutic strategies inconsistent with international recommendations	1 day
Secondary	patients profile with inappropriate antibiotic therapy	profile of patients with inappropriate antibiotic therapy	1 day
Secondary	patients profile with infectious disease	profile of patients with infectious disease	1 day