Antibiotic AbuseNCT06503055
Antibiotic Abuse Patterns in Gharbia, Egypt
An observational study of Antibiotic Abuse, run by Rania Mamdouh Elkafoury at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Abuse
- What is being tested?
- Questionnaire
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 15 Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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).
Who may be able to join
- All medical field professionals and students with any specialty can participate in the survey
- Population more than 18 years old
- Parents of children less than 18 years old.
Who cannot join
- Participants outside the Gharbia governorate.
- Unwilling to participate
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tropical medicine department, Tanta University Hospitals
Tanta, Gharbyea, 31527
Ferial Elkalla, MD, 00201006023289, f.elkalla@gmail.com
Shimaa M Ebrahim, MD
About this study
Official title: Antibiotic Abuse Patterns: Medical Field And Population-Based Survey In Gharbia Governorate, Egypt
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.
Read more
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.
Read the 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 maintained(the 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.
- Conditions
- Antibiotic Abuse
- Being tested
- Questionnaire
- Keywords
- Antibiotic abuse, Antibiotic resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
A questionnaire targeting a convenience sample of medical field professionals including physicians with different specialties, pharmacists, medical students, nursing staff, and the general population in Gharbia governorate (about 1000 subjects).
The questionnaire will be written and digital in both Arabic and English versions. Moreover, an awareness campaign will be designed to educate the participants on appropriate antibiotic use principles.
| Study group | Role | What they receive |
|---|---|---|
| General population | The questionnaire will target a convenience sample of the general population in the Gharbia governorate. Receives: Other: Questionnaire | |
| Healthcare professionals | The questionnaire will target a convenience sample of healthcare professionals in the Gharbia governorate including physicians with different specialties, pharmacists, medical students, and nursing staff. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of antibiotic abuse
using a questionnaire to assess prevalence of antibiotic abuse among both medical field professionals and the public.
Measured: till August 2024
Secondary outcomes (2)
factors leading to antibiotic misuse
using a questionnaire to understand the factors leading to antibiotic misuse.
Measured: till August 2024
awareness of antibiotic resistance
using a questionnaire to evaluate awareness levels about antibiotic use and antibiotic resistance.
Measured: till August 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 May 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic AbuseStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rania Mamdouh Elkafoury
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rania Mamdouh Elkafoury, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503055
- Sponsor's protocol ID
- 36264PR630/4/24
- Status last verified
- Aug 2024
- First submitted
- 9 Jul 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Abuse Patterns: Medical Field And Population-Based Survey In Gharbia Governorate, Egypt
- ClinicalTrials.gov ID
- NCT06503055
- Acronym / sponsor ID
- 36264PR630/4/24
- Conditions
- Antibiotic Abuse
- Keywords
- Antibiotic abuse, Antibiotic resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Rania Mamdouh ElkafouryUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 16 Jul 2024 (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.
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.
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 maintained(the 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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General population | – | Other: QuestionnaireThe questionnaire will target a convenience sample of the general population in the Gharbia governorate. |
| Healthcare professionals | – | Other: QuestionnaireThe questionnaire will target a convenience sample of healthcare professionals in the Gharbia governorate including physicians with different specialties, pharmacists, medical students, and nursing staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (3 listed)
- All medical field professionals and students with any specialty can participate in the survey
- Population more than 18 years old
- Parents of children less than 18 years old.
Key exclusion criteria (2 listed)
- Participants outside the Gharbia governorate.
- Unwilling to participate
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 |
|---|---|---|
| QuestionnaireA questionnaire targeting a convenience sample of medical field professionals including physicians with different specialties, pharmacists, medical students, nursing staff, and the general population in Gharbia governorate (about 1000 subjects). The questionnaire will be written and digital in both Arabic and English versions. Moreover, an awareness campaign will be designed to educate the participants on appropriate antibiotic use principles. | Other | General population, Healthcare professionals |
Primary outcome
prevalence of antibiotic abuse
Time frame: till August 2024
using a questionnaire to assess prevalence of antibiotic abuse among both medical field professionals and the public.
2 secondary outcomes
factors leading to antibiotic misuse
Time frame: till August 2024
awareness of antibiotic resistance
Time frame: till August 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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.
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 Abuse, run by Rania Mamdouh Elkafoury 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 3 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rania M Elkafoury, MD (01004672358, rania.elkafoury@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of antibiotic abuse (time frame: till August 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2024.