Drug ReactionNCT06428162
An Evaluation of Healthcare Providers' Adherence to Pharmacovigilance Practices in an African Community
An observational study of Drug Reaction and Drug Hypersensitivity, run by Deraya University at 1 site in Egypt.
Trial summary
Egypt's several regions-rural, mixed, and urban-were given pre-designed surveys pertaining to drug adverse events and the role of pharmacovigilance in detection and reporting. The three sections of the survey were dedicated to studying health care professionals' knowledge concerning pharmacovigilance concepts and… Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Reaction, Drug Hypersensitivity, Drug Abuse
- What is being tested?
- questionner
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Feb 2024to 20 Jun 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: all health care providers that deals with drugs and medications as pharmacists, physicians, Dentists, nurses and medical reps are invited to share in this survey as a hard template. study included 300 subject in different disciplines at the period at 3 months. complete survey composed of 3 sections included previous reported ADVEs
Who may be able to join
- all health care providers are invited to share in the study
- minimum experience required is one year in health carrier.
- accept sharing in the study
Who cannot join
- health care providers who refuse to complete all data required in the survey.
- fresh experience or participants who left health carrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: an Observational Study for the Prevalence of Pharmacovigilance Practices Between Healthcare Providers in North African Nation
Egypt's several regions-rural, mixed, and urban-were given pre-designed surveys pertaining to drug adverse events and the role of pharmacovigilance in detection and reporting. The three sections of the survey were dedicated to studying health care professionals' knowledge concerning pharmacovigilance concepts and practices, as well as demographics and people reported or not reported. The survey also asked more questions regarding adverse occurrences that were reported.
- Conditions
- Drug Reaction, Drug Hypersensitivity, Drug Abuse, Drug Interaction
- Being tested
- questionner
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Drug Hypersensitivity, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnerOther
three sections questioner including: demographics, reported cases, unreported cases
What is being measured
The primary outcome is the main question the study is designed to answer.
reported adverse drug reactions
collect recent adverse drug reaction reports
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start18 Feb 2024
- Primary completion20 May 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug ReactionStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soad Ali, Deraya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428162
- Sponsor's protocol ID
- 2024 PV
- Status last verified
- Aug 2024
- First submitted
- 20 May 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- an Observational Study for the Prevalence of Pharmacovigilance Practices Between Healthcare Providers in North African Nation
- ClinicalTrials.gov ID
- NCT06428162
- Acronym / sponsor ID
- 2024 PV
- Conditions
- Drug Reaction, Drug Hypersensitivity, Drug Abuse, Drug Interaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 24 May 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.
Egypt's several regions-rural, mixed, and urban-were given pre-designed surveys pertaining to drug adverse events and the role of pharmacovigilance in detection and reporting. The three sections of the survey were dedicated to studying health care professionals' knowledge concerning pharmacovigilance concepts and practices, as well as demographics and people reported or not reported. The survey also asked more questions regarding adverse occurrences that were reported.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- all health care providers that deals with drugs and medications as pharmacists, physicians, Dentists, nurses and medical reps are invited to share in this survey as a hard template. study included 300 subject in different disciplines at the period at 3 months. complete survey composed of 3 sections included previous reported ADVEs
Key inclusion criteria (3 listed)
- all health care providers are invited to share in the study
- minimum experience required is one year in health carrier.
- accept sharing in the study
Key exclusion criteria (2 listed)
- health care providers who refuse to complete all data required in the survey.
- fresh experience or participants who left health carrier
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 |
|---|---|---|
| questionnerthree sections questioner including: demographics, reported cases, unreported cases | Other | – |
Primary outcome
reported adverse drug reactions
Time frame: 3 months
collect recent adverse drug reaction reports
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 7 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Drug Reaction and Drug Hypersensitivity, run by Deraya 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 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: finished, as of the sponsor's last update on 7 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?
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?
reported adverse drug reactions (time frame: 3 months). 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 7 Aug 2024.