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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04127682
Other study ID # AMR_PH01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date October 30, 2022

Study information

Verified date November 2022
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. It is important to study physicians' antibiotic prescribing behavior to understand its determinant and for further planning of appropriate interventions to optimize antibiotic prescription.


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.


Recruitment information / eligibility

Status Completed
Enrollment 186
Est. completion date October 30, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion criteria: 1. Physicians dealing with pediatric cases. 2. GPs, pediatrics, or otolaryngology (ENT) residents. Exclusion criteria: 1. Physician who didn't work at outpatient clinics. 2. Physicians who are specialized and hold a degree.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Egypt Faculty of medicine- Assiut university Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Amin 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. P — View Citation

Dooling 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. — View Citation

Meeker 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Physicians knowledge of antibiotic resistance By self administered questionnaire 6 months
Primary Attitude and practice of physicians as regard antibiotic prescription in pediatric cases of acute upper respiratory tract infections. By self administered questionnaire 6 months
Secondary Determinants of physicians' antibiotic prescribing behavior in cases of acute upper respiratory tract infection in children. By self administered questionnaire 6 months
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