Antibiotic Sore TongueAORDNCT04482231
Antibiotic Observatory for Respiratory Diseases, Apart From Tuberculosis and Reportable Diseases
An observational study of Antibiotic Sore Tongue, run by University of Monastir at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Antibiotic Sore Tongue
- How many people
- 9,944 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Jan 2018to 31 Aug 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- patients with lower and upper RTIs who recieved antibiotic treatment.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Emergency department of fattouma bourguiba university hospital
Monastir, 5020
About this study
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.
Read the 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.
- Conditions
- Antibiotic Sore Tongue
- Keywords
- antiobiotic,, respiratory tract infections, appropriateness
- Medical subject headings
- Respiratory Tract Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriateness of antibiotic prescription
dichotomous (yes / no) criterion that characterizes appropriate or inappropriate use of antibiotics based on respiratory indication and patient profile
Measured: 1 day
Secondary outcomes (4)
inappropriatness of antibiotic prescription
number of inappropriate antibiotic prescriptions by clinical indication
Measured: 1 day
international recommendations
description of therapeutic strategies inconsistent with international recommendations
Measured: 1 day
patients profile with inappropriate antibiotic therapy
profile of patients with inappropriate antibiotic therapy
Measured: 1 day
patients profile with infectious disease
profile of patients with infectious disease
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start2 Jan 2018
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Sore TongueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 9,944 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- nouira semir, MD, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482231
- Sponsor's protocol ID
- BAROMETRE
- Acronym
- AORD
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bel Haj Ali K, Sekma A, Messous S, Trabelsi I, Ben Youssef J, Maghraoui H, Razgallah R, Walha A, Grissa MH, Beltaief K, Mezgar Z, Coubantini A, Bouida W, Msolli MA, Boukef R, Boubaker H, Nouira S. Appropriateness of antibiotic treatment of acute respiratory tract infections in Tunisian primary care and emergency departments: a multicenter cross-sectional study. BMC Prim Care. 2022 Nov 22;23(1):295. doi: 10.1186/s12875-022-01904-7.
PubMed 36418965
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Observatory for Respiratory Diseases, Apart From Tuberculosis and Reportable Diseases
- ClinicalTrials.gov ID
- NCT04482231
- Acronym / sponsor ID
- AORD / BAROMETRE
- Conditions
- Antibiotic Sore Tongue
- Keywords
- antiobiotic,, respiratory tract infections, appropriateness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,944 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients with lower and upper RTIs who recieved antibiotic treatment.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
inappropriatness of antibiotic prescription
Time frame: 1 day
international recommendations
Time frame: 1 day
patients profile with inappropriate antibiotic therapy
Time frame: 1 day
patients profile with infectious disease
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Derived from this study: PubMed 36418965Bel Haj Ali K, Sekma A, Messous S, Trabelsi I, Ben Youssef J, Maghraoui H, Razgallah R, Walha A, Grissa MH, Beltaief K, Mezgar Z, Coubantini A, Bouida W, Msolli MA, Boukef R, Boubaker H, Nouira S. Appropriateness of antibiotic treatment of acute respiratory tract infections in Tunisian primary care and emergency departments: a multicenter cross-sectional study. BMC Prim Care. 2022 Nov 22;23(1):295. doi: 10.1186/s12875-022-01904-7.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nouira semir, MD principal investigator
University of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Sore Tongue, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appropriateness of antibiotic prescription (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04482231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.