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

• ClinicalTrials.gov Identifier: NCT04482231
• Recruitment Status: Completed
• First Posted: July 22, 2020
• Last Update Posted: July 22, 2020
• Sponsor: University of Monastir
• Information provided by (Responsible Party): Pr. Semir Nouira, University of Monastir

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 9944 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Target Follow-Up Duration: 1 Day
• Official Title: Antibiotic Observatory for Respiratory Diseases, Apart From Tuberculosis and Reportable Diseases
• Actual Study Start Date: January 2, 2018
• Actual Primary Completion Date: August 31, 2018
• Actual Study Completion Date: August 31, 2018

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes 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.

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

Contacts and Locations

Locations

Tunisia

Emergency department of fattouma bourguiba university hospital

Monastir, Tunisia, 5020

Sponsors and Collaborators

University of Monastir

Investigators

• Principal Investigator: nouira semir, MD; University of Monastir

More Information

• Responsible Party: Pr. Semir Nouira, professor semir nouira, University of Monastir
• ClinicalTrials.gov Identifier: NCT04482231
• Other Study ID Numbers: BAROMETRE
• First Posted: July 22, 2020
• Last Update Posted: July 22, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pr. Semir Nouira, University of Monastir:

antiobiotic,; respiratory tract infections; appropriateness

Additional relevant MeSH terms:

Tuberculosis; Respiration Disorders; Respiratory Tract Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections