Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503055
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Antibiotic Abuse Patterns in Gharbia Egypt
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Antibiotic Abuse Patterns Medical Field And Population-Based Survey In Gharbia Governorate Egypt
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Antimicrobial resistance AMR represents a serious problem described by the World Health Organization WHO as a global public health concern Research from around the globe indicates high rates of practices related to injudicious use of antibiotics as leftover antibiotics antibiotic non-adherence the pressure made by patients who request antibiotics from clinicians unwarranted provision of antibiotics by physicians and pharmacists antibiotic abuse and misuse in the form of overuse or underuse
Moreover many patients believe they have the right to self-prescribe an antibiotic or get one from friends and family About 50 of antibiotic use is done improperly using the wrong agent dose or duration
In Egypt antibiotic misuse and overuse led to a high prevalence of multidrug-resistant MDR bacteria among the population
The current work aims to assess the prevalence of antibiotic abuse among medical field professionals and the public and understand the factors leading to antibiotic misuse thus evaluating awareness levels regarding antibiotic resistance
Moreover many patients believe they have the right to self-prescribe an antibiotic or get one from friends and family About 50 of antibiotic use is done improperly using the wrong agent dose or duration
In Egypt antibiotic misuse and overuse led to a high prevalence of multidrug-resistant MDR bacteria among the population
The current work aims to assess the prevalence of antibiotic abuse among medical field professionals and the public and understand the factors leading to antibiotic misuse thus evaluating awareness levels regarding antibiotic resistance
Detailed Description:
This scientific research will be done by a collaboration of both the Tropical Medicine Department and the Public Health Department at Tanta University Hospital as a cross-sectional study using a digital and written questionnaire this questionnaire will target medical field professionals and the public in Gharbia governorate
Type of study
Prospective cross-sectional survey
Duration of study
The study will be carried out from May 2024 to August 2024 or until the target number is reached
Target subjects
The questionnaire will target a convenience sample of medical field professionals and the public in the Gharbia governorate including physicians with different specialties pharmacists medical students nursing staff and the general population about 1000 subjects
The questionnaire will be written and digital in both Arabic and English version Moreover an awareness campaign will be designed to educate the participants on appropriate antibiotic use principles
Methodology
After designing the questionnaire it will be discussed with other experts in this field where the validity and reliability will be assessed and a pilot study will be done
After informed consent the subject will answer a designed questionnaire either written or digital 2 phases will be done Phase 1 The questionnaire will be divided into 3 sectors Sector 1 Demographic data questions about age sex residence educational level occupation subspeciality workplace for all participants
Sector 2 Socioeconomic level determination mainly for population Socio-economic data as the number of family members rooms in the apartment level of education occupation and cost per month
Sector 3 the main work includes questions for the population behavior of seeking medical advice the last use of antibiotic type and duration adherence to the prescribed regimen who prescribed and why side effects if there are any laboratory investigations done to determine the correct antimicrobial use duration between 2 consequent antibiotic use number of antibiotic used in the last time and how many times of antibiotic use in the last six months
For prescriber most type of antibiotic used in the last six months how many times antibiotic was prescribed patient criteria for whom antibiotic prescribed any lab done to determine the propitiate antibiotic durations of antibiotic prescription perception of patients to the prescribed antibiotic patients stress in demanding antibiotic prescription the outcome of this prescription duration between 2 consequent prescriptions in the same patient and use of more than one combination in the same patient within the same time Phase 2 An awareness campaign will be designed to educate the participants on appropriate antibiotic use principles
Ethical considerations
A written or digital informed consent form authorizing the collection of this data will be signed by all subjects The study will be approved by the Ethical Committee of the Faculty of Medicine at Tanta University
The risks to the participants and measures needed to minimize these risks
The privacy of the data of the patients will be maintainedthe procedure will be discussed later in this protocol
Any unexpected risks that appear during research will be cleared to the subjects and the ethical committee on time
Adequate provisions to maintain the privacy of participants and confidentially of data are as follows
A code number for each patient will be used and symbols for the name and address will be kept in a special file
The patients names will be hidden when we use the research
The research results will be used only for scientific aims and not for other aims
Type of study
Prospective cross-sectional survey
Duration of study
The study will be carried out from May 2024 to August 2024 or until the target number is reached
Target subjects
The questionnaire will target a convenience sample of medical field professionals and the public in the Gharbia governorate including physicians with different specialties pharmacists medical students nursing staff and the general population about 1000 subjects
The questionnaire will be written and digital in both Arabic and English version Moreover an awareness campaign will be designed to educate the participants on appropriate antibiotic use principles
Methodology
After designing the questionnaire it will be discussed with other experts in this field where the validity and reliability will be assessed and a pilot study will be done
After informed consent the subject will answer a designed questionnaire either written or digital 2 phases will be done Phase 1 The questionnaire will be divided into 3 sectors Sector 1 Demographic data questions about age sex residence educational level occupation subspeciality workplace for all participants
Sector 2 Socioeconomic level determination mainly for population Socio-economic data as the number of family members rooms in the apartment level of education occupation and cost per month
Sector 3 the main work includes questions for the population behavior of seeking medical advice the last use of antibiotic type and duration adherence to the prescribed regimen who prescribed and why side effects if there are any laboratory investigations done to determine the correct antimicrobial use duration between 2 consequent antibiotic use number of antibiotic used in the last time and how many times of antibiotic use in the last six months
For prescriber most type of antibiotic used in the last six months how many times antibiotic was prescribed patient criteria for whom antibiotic prescribed any lab done to determine the propitiate antibiotic durations of antibiotic prescription perception of patients to the prescribed antibiotic patients stress in demanding antibiotic prescription the outcome of this prescription duration between 2 consequent prescriptions in the same patient and use of more than one combination in the same patient within the same time Phase 2 An awareness campaign will be designed to educate the participants on appropriate antibiotic use principles
Ethical considerations
A written or digital informed consent form authorizing the collection of this data will be signed by all subjects The study will be approved by the Ethical Committee of the Faculty of Medicine at Tanta University
The risks to the participants and measures needed to minimize these risks
The privacy of the data of the patients will be maintainedthe procedure will be discussed later in this protocol
Any unexpected risks that appear during research will be cleared to the subjects and the ethical committee on time
Adequate provisions to maintain the privacy of participants and confidentially of data are as follows
A code number for each patient will be used and symbols for the name and address will be kept in a special file
The patients names will be hidden when we use the research
The research results will be used only for scientific aims and not for other aims
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None