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Completed

NCT Number: NCT04482231

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emergency department of fattouma bourguiba university hospital

Monastir, 5020, Tunisia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. inappropriatness of antibiotic prescription

    Time frame: 1 day

    number of inappropriate antibiotic prescriptions by clinical indication

  2. international recommendations

    Time frame: 1 day

    description of therapeutic strategies inconsistent with international recommendations

  3. patients profile with inappropriate antibiotic therapy

    Time frame: 1 day

    profile of patients with inappropriate antibiotic therapy

  4. patients profile with infectious disease

    Time frame: 1 day

    profile of patients with infectious disease

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Acronym: AORD

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 22, 2020
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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