Antibiotic Observatory for Respiratory Diseases, Apart From Tuberculosis and Reportable Diseases (AORD)

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.

Study Overview

• Status: Completed
• Conditions: Antibiotic Sore Tongue

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 Type: Observational
• Enrollment (Actual): 9944

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5020
    • Emergency department of fattouma bourguiba university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Monastir

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: respiratory tract infections; appropriateness; antiobiotic,
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: BAROMETRE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No