Antibiotic Side EffectNCT04127682
Antibiotic Prescription for Children With Acute Upper Respiratory Tract Infections in Assiut District
An observational study of Antibiotic Side Effect, run by Assiut University at 1 site in Egypt.
Trial summary
Antibiotics are one of the most commonly prescribed drugs in pediatric care all over the world. Over prescription of antibiotics is a major public health problem and the most important factor in the emergence of antibiotic resistance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antibiotic Side Effect
- What is being tested?
- Antibiotic KAP questionnaire
- How many people
- 186 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 30 Oct 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Physicians dealing with cases of pediatrics' acute URIs at PHC units either urban or rural, insurance hospitals or Assiut university hospitals.
Who may be able to join
- Physicians dealing with pediatric cases.
- GPs, pediatrics, or otolaryngology (ENT) residents.
Who cannot join
- Physician who didn't work at outpatient clinics.
- Physicians who are specialized and hold a degree.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antibiotic Prescription for Children With Acute Upper Respiratory Tract Infections in Assiut District: An Exploratory Study.
Antibiotics are one of the most commonly prescribed drugs in pediatric care all over the world. Over prescription of antibiotics is a major public health problem and the most important factor in the emergence of antibiotic resistance. It is important to study physicians' antibiotic prescribing behavior to understand its determinant and for further planning of appropriate interventions to optimize antibiotic prescription.
Read the detailed description
Antibiotics are one of the most commonly prescribed drugs in pediatric care all over the world. Over prescription of antibiotics is a major public health problem and the most important factor in the emergence of antibiotic resistance.
In Egypt, a recent study conducted in El-Minya governorate to investigate antibiotic use in PHC centres and in governmental hospitals, revealed that physician prescriptions of antibiotics for ARIs were extremely high as 82% of pediatric visits for ARIs resulted in an antibiotic prescription. Most of these infections are caused by viruses and do not require antibiotic treatment.
Numerous interventions to improve antibiotic prescribing practices have been reported from various countries with varying results. No single intervention appears to have superior efficacy, but combinations of interventions are typically more effective, and strategies that target health care professionals and/or patients (or parents of young children) have achieved success at reducing antibiotic prescriptions for ARIs.
Despite the emergence of antibiotic resistance and international efforts to reduce antibiotic use, prescription still high and inappropriate. Children are a vulnerable group and inappropriate antibiotic prescription may affect their health and may contribute to development of many diseases as allergies beside emergence of antibiotic resistance. Also, most of acute respiratory infections in children are viral infections and they receive antibiotic for it. So,, it is important to study physicians' antibiotic prescribing behavior to understand its determinant and for further planning of appropriate interventions to optimize antibiotic prescription.
- Conditions
- Antibiotic Side Effect
- Being tested
- Antibiotic KAP questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic KAP questionnaireOther
- Self-administered questionnaire will be used and containing following Physician information (age, sex, place of work, specialty, years of experience, place of work, and post graduate studies and trainings), Practice information (number of days for outpatient's practice/week, average number of patients /day and average percentage of children with ARIs/day), Antibiotic prescription practice (using of guidelines and causes of prescribing antibiotics in acute URIs), Knowledge about antibiotic resistance and attendance of any conference or educational activities concerned with antibiotic use during the last year, Attitude as regard antibiotic prescription.
| Study group | Role | What they receive |
|---|---|---|
| Physicians | Physicians dealing with cases of pediatrics' acute URIs at PHC units either urban or rural, insurance hospitals or Assiut university hospitals. Receives: Other: Antibiotic KAP questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physicians knowledge of antibiotic resistance
By self administered questionnaire
Measured: 6 months
Attitude and practice of physicians as regard antibiotic prescription in pediatric cases of acute upper respiratory tract infections.
By self administered questionnaire
Measured: 6 months
Secondary outcomes (1)
Determinants of physicians' antibiotic prescribing behavior in cases of acute upper respiratory tract infection in children.
By self administered questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Jan 2021
- Primary completion30 Jul 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Side EffectStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam T. Amin, Assiut University
- Investigators
- Mahmoud A Abd El Aty, Study director, Public Health Department, Faculty of Medicine, Assiut UniversitySabra M Ahmed, Study director, Public Health Department, Faculty of Medicine, Assiut UniversityGhada O El-Sadafi, Study director, Pediatrics department, Faculty of Medicine, Assiut UniversityAmira F El-Gazzar, Study director, Public Health Department, Faculty of Medicine, Assiut UniversityMariam T Amin, Principal investigator, Public Health Department, Faculty of Medicine, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127682
- Sponsor's protocol ID
- AMR_PH01
- Status last verified
- Nov 2022
- First submitted
- 13 Oct 2019
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tamma PD, Cosgrove SE. Let the games begin: the race to optimise antibiotic use. Lancet Infect Dis. 2014 Aug;14(8):667-668. doi: 10.1016/S1473-3099(14)70809-6. Epub 2014 Jul 9. No abstract available.
PubMed 25022437Dooling KL, Kandeel A, Hicks LA, El-Shoubary W, Fawzi K, Kandeel Y, Etman A, Lohiniva AL, Talaat M. Understanding Antibiotic Use in Minya District, Egypt: Physician and Pharmacist Prescribing and the Factors Influencing Their Practices. Antibiotics (Basel). 2014 Jun 20;3(2):233-43. doi: 10.3390/antibiotics3020233.
PubMed 27025746Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.
PubMed 26864410Amin MT, Abd El Aty MA, Ahmed SM, Elsedfy GO, Hassanin ES, El-Gazzar AF. Over prescription of antibiotics in children with acute upper respiratory tract infections: A study on the knowledge, attitude and practices of non-specialized physicians in Egypt. PLoS One. 2022 Nov 3;17(11):e0277308. doi: 10.1371/journal.pone.0277308. eCollection 2022.
PubMed 36327297
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prescription for Children With Acute Upper Respiratory Tract Infections in Assiut District: An Exploratory Study.
- ClinicalTrials.gov ID
- NCT04127682
- Acronym / sponsor ID
- AMR_PH01
- Conditions
- Antibiotic Side Effect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 15 Oct 2019 (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.
Antibiotics are one of the most commonly prescribed drugs in pediatric care all over the world. Over prescription of antibiotics is a major public health problem and the most important factor in the emergence of antibiotic resistance. It is important to study physicians' antibiotic prescribing behavior to understand its determinant and for further planning of appropriate interventions to optimize antibiotic prescription.
Detailed description
Antibiotics are one of the most commonly prescribed drugs in pediatric care all over the world. Over prescription of antibiotics is a major public health problem and the most important factor in the emergence of antibiotic resistance.
In Egypt, a recent study conducted in El-Minya governorate to investigate antibiotic use in PHC centres and in governmental hospitals, revealed that physician prescriptions of antibiotics for ARIs were extremely high as 82% of pediatric visits for ARIs resulted in an antibiotic prescription. Most of these infections are caused by viruses and do not require antibiotic treatment.
Numerous interventions to improve antibiotic prescribing practices have been reported from various countries with varying results. No single intervention appears to have superior efficacy, but combinations of interventions are typically more effective, and strategies that target health care professionals and/or patients (or parents of young children) have achieved success at reducing antibiotic prescriptions for ARIs.
Despite the emergence of antibiotic resistance and international efforts to reduce antibiotic use, prescription still high and inappropriate. Children are a vulnerable group and inappropriate antibiotic prescription may affect their health and may contribute to development of many diseases as allergies beside emergence of antibiotic resistance. Also, most of acute respiratory infections in children are viral infections and they receive antibiotic for it. So,, it is important to study physicians' antibiotic prescribing behavior to understand its determinant and for further planning of appropriate interventions to optimize antibiotic prescription.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physicians | – | Other: Antibiotic KAP questionnairePhysicians dealing with cases of pediatrics' acute URIs at PHC units either urban or rural, insurance hospitals or Assiut university hospitals. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Physicians dealing with cases of pediatrics' acute URIs at PHC units either urban or rural, insurance hospitals or Assiut university hospitals.
Key inclusion criteria (2 listed)
- Physicians dealing with pediatric cases.
- GPs, pediatrics, or otolaryngology (ENT) residents.
Key exclusion criteria (2 listed)
- Physician who didn't work at outpatient clinics.
- Physicians who are specialized and hold a degree.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic KAP questionnaire• Self-administered questionnaire will be used and containing following Physician information (age, sex, place of work, specialty, years of experience, place of work, and post graduate studies and trainings), Practice information (number of days for outpatient's practice/week, average number of patients /day and average percentage of children with ARIs/day), Antibiotic prescription practice (using of guidelines and causes of prescribing antibiotics in acute URIs), Knowledge about antibiotic resistance and attendance of any conference or educational activities concerned with antibiotic use during the last year, Attitude as regard antibiotic prescription. | Other | Physicians |
Primary outcome
Physicians knowledge of antibiotic resistance
Time frame: 6 months
By self administered questionnaire
Attitude and practice of physicians as regard antibiotic prescription in pediatric cases of acute upper respiratory tract infections.
Time frame: 6 months
By self administered questionnaire
1 secondary outcome
Determinants of physicians' antibiotic prescribing behavior in cases of acute upper respiratory tract infection in children.
Time frame: 6 months
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 8 Nov 2022.
- Background: PubMed 25022437Tamma PD, Cosgrove SE. Let the games begin: the race to optimise antibiotic use. Lancet Infect Dis. 2014 Aug;14(8):667-668. doi: 10.1016/S1473-3099(14)70809-6. Epub 2014 Jul 9. No abstract available.
- Background: PubMed 27025746Dooling KL, Kandeel A, Hicks LA, El-Shoubary W, Fawzi K, Kandeel Y, Etman A, Lohiniva AL, Talaat M. Understanding Antibiotic Use in Minya District, Egypt: Physician and Pharmacist Prescribing and the Factors Influencing Their Practices. Antibiotics (Basel). 2014 Jun 20;3(2):233-43. doi: 10.3390/antibiotics3020233.
- Background: PubMed 26864410Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.
- Results publication: PubMed 36327297Amin MT, Abd El Aty MA, Ahmed SM, Elsedfy GO, Hassanin ES, El-Gazzar AF. Over prescription of antibiotics in children with acute upper respiratory tract infections: A study on the knowledge, attitude and practices of non-specialized physicians in Egypt. PLoS One. 2022 Nov 3;17(11):e0277308. doi: 10.1371/journal.pone.0277308. eCollection 2022.
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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.
Mahmoud A Abd El Aty study director
Public Health Department, Faculty of Medicine, Assiut University
Sabra M Ahmed study director
Public Health Department, Faculty of Medicine, Assiut University
Ghada O El-Sadafi study director
Pediatrics department, Faculty of Medicine, Assiut University
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 Side Effect, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 2 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 8 Nov 2022. 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 Egypt. 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?
Physicians knowledge of antibiotic resistance (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT04127682, which also lists 4 linked publications.
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 8 Nov 2022.