NCT04127682

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

1.6 years

First QC Date

October 13, 2019

Last Update Submit

November 4, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Physicians knowledge of antibiotic resistance

    By self administered questionnaire

    6 months

  • 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 Outcomes (1)

  • Determinants of physicians' antibiotic prescribing behavior in cases of acute upper respiratory tract infection in children.

    6 months

Study Arms (1)

Physicians

Physicians dealing with cases of pediatrics' acute URIs at PHC units either urban or rural, insurance hospitals or Assiut university hospitals.

Other: Antibiotic KAP questionnaire

Interventions

• 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.

Physicians

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Physicians dealing with cases of pediatrics' acute URIs at PHC units either urban or rural, insurance hospitals or Assiut university hospitals.

You may qualify if:

  • Physicians dealing with pediatric cases.
  • GPs, pediatrics, or otolaryngology (ENT) residents.

You may not qualify if:

  • Physician who didn't work at outpatient clinics.
  • Physicians who are specialized and hold a degree.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine- Assiut university

Asyut, 71515, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 25022437BACKGROUND
  • 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.

    PMID: 27025746BACKGROUND
  • 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.

    PMID: 26864410BACKGROUND
  • 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. PLoS One. 2022 Nov 3;17(11):e0277308. doi: 10.1371/journal.pone.0277308. eCollection 2022.

Study Officials

  • Mahmoud A Abd El Aty

    Public Health Department, Faculty of Medicine, Assiut University

    STUDY DIRECTOR
  • Sabra M Ahmed

    Public Health Department, Faculty of Medicine, Assiut University

    STUDY DIRECTOR
  • Ghada O El-Sadafi

    Pediatrics department, Faculty of Medicine, Assiut University

    STUDY DIRECTOR
  • Amira F El-Gazzar

    Public Health Department, Faculty of Medicine, Assiut University

    STUDY DIRECTOR
  • Mariam T Amin

    Public Health Department, Faculty of Medicine, Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

October 13, 2019

First Posted

October 15, 2019

Study Start

January 1, 2021

Primary Completion

July 30, 2022

Study Completion

October 30, 2022

Last Updated

November 8, 2022

Record last verified: 2022-11

Locations