Adverse Drug EventMedeANCT06607445
Evaluation of the Implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service.
An observational study of Adverse Drug Event, run by Complejo Hospitalario Universitario de Badajoz at 1 site in Spain.
Trial summary
An open longitudinal observational study, non-randomized, which will include the adult population, attended by the SES, in which preference will be given to those patients under treatment with drugs that can produce relevant adverse effects. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Adverse Drug Event
- How many people
- 6,445 participants
- Where
- 1 siteSpain
- Study dates
- 26 May 2021to 31 Dec 2024
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Consecutive sampling is a widely used non-probability sampling that, if performed correctly, can be considered as random sampling. In this case, patients are selected as they come for consultation and as long as they meet the inclusion criteria. SES patients are eligible for inclusion in the study, so that a minimum of 3000 participants are expected to be included in the study in order to ensure adequate frequency of genetic polymorphisms of pharmacogenetic relevance. During the Deployment Phase of the Prescription Support Program, it is estimated that an additional 4,000 to 8,000 patients will be included, with a target of 0.1% of the population of Extremadura.
Who may be able to join
- Patients with a recent diagnosis and who are to be or are being treated according to usual clinical practice, who meet the criteria to participate in the study, read the corresponding information sheet, sign informed consent and agree to participate, provided they meet the following inclusion criteria:
- General criteria for all patients:
- Age ≥ 18 years. In case of minors, they may be included, under the following assumptions:
- If the minor is under 12 years of age, participation will require the consent and signature of the informed consent document by both parents (or their guardian).
- If the minor is between 12 and 16 years of age, a proxy informed consent form will be provided and signed by both parents (if both parents are present at the time of the interview) or only one of them (in which case one of the following two conditions must be stated: that the other parent is not present at the time of the interview but does not object to the participation of the minor in the study or that the signatory is the sole legal guardian of the minor).
- Be registered or potentially/have been attended in the Extremadura Health Service.
- Not have language or communication barrier or present disability being totally dependent on another person.
Who cannot join
- Failure to meet any of the inclusion criteria described above.
- Refusal by the patient to be part of the cohort initially, or to continue to be part of the cohort during follow-up.
- Manifest difficulty for follow-up.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Complejo Hospitalario Universitario de Badajoz
Badajoz, 06080
Adrián LLerena, Doctor, +34 924218040, adrian.llerena@salud-juntaex.es
About this study
Official title: Evaluation of the Implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service. Population Cohort [MedeA21].
An open longitudinal observational study, non-randomized, which will include the adult population, attended by the SES, in which preference will be given to those patients under treatment with drugs that can produce relevant adverse effects. It is a naturalistic study in which no pharmacological or other type of intervention will be carried out, only the information recommended in the drug data sheet (pharmacogenetic biomarkers, relevant interactions and clinical contraindications) will be provided.
- Conditions
- Adverse Drug Event
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lusitania | Primary health care | |
| Celtici | Oncology | |
| Vettonia | Mental health | |
| Turdulia | Internal medicine | |
| Lácara | Nephrology | |
| Tartessos | Neurology | |
| Cancho Roano | Emergencies | |
| Oretania | Cardiology | |
| Carpetania | Rheumatology | |
| Baeturia | Transplants | |
| Endovélico | Infectious | |
| Sirona | Clinical pharmacology | |
| Gaudeamus | University of extremadura | |
| Sucellus | Urology | |
| Mnemosyne | Neurology-Vascular | |
| Paidos | Pediatrics | |
| Turuñuelo | Pneumology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service.
To analyze the implementation in the clinical routine of a pharmacogenetics and personalized medicine program in SES patients, evaluating the overall impact on the health system, and at the individual level, general modifications in the clinical response and its temporal evolution.
Measured: December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start26 May 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Drug EventStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 6,445 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Complejo Hospitalario Universitario de Badajoz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607445
- Sponsor's protocol ID
- MedeA21.01
- Acronym
- MedeA
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 23 Sep 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 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service. Population Cohort [MedeA21].
- ClinicalTrials.gov ID
- NCT06607445
- Acronym / sponsor ID
- MedeA / MedeA21.01
- Conditions
- Adverse Drug Event
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,445 participants (estimated)
- Lead sponsor
- Complejo Hospitalario Universitario de BadajozUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Sep 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.
An open longitudinal observational study, non-randomized, which will include the adult population, attended by the SES, in which preference will be given to those patients under treatment with drugs that can produce relevant adverse effects. It is a naturalistic study in which no pharmacological or other type of intervention will be carried out, only the information recommended in the drug data sheet (pharmacogenetic biomarkers, relevant interactions and clinical contraindications) will be provided.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Lusitania | – | –Primary health care |
| Celtici | – | –Oncology |
| Vettonia | – | –Mental health |
| Turdulia | – | –Internal medicine |
| Lácara | – | –Nephrology |
| Tartessos | – | –Neurology |
| Cancho Roano | – | –Emergencies |
| Oretania | – | –Cardiology |
| Carpetania | – | –Rheumatology |
| Baeturia | – | –Transplants |
| Endovélico | – | –Infectious |
| Sirona | – | –Clinical pharmacology |
| Gaudeamus | – | –University of extremadura |
| Sucellus | – | –Urology |
| Mnemosyne | – | –Neurology-Vascular |
| Paidos | – | –Pediatrics |
| Turuñuelo | – | –Pneumology |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive sampling is a widely used non-probability sampling that, if performed correctly, can be considered as random sampling. In this case, patients are selected as they come for consultation and as long as they meet the inclusion criteria. SES patients are eligible for inclusion in the study, so that a minimum of 3000 participants are expected to be included in the study in order to ensure adequate frequency of genetic polymorphisms of pharmacogenetic relevance. During the Deployment Phase of the Prescription Support Program, it is estimated that an additional 4,000 to 8,000 patients will be included, with a target of 0.1% of the population of Extremadura.
Key inclusion criteria (7 listed)
- Patients with a recent diagnosis and who are to be or are being treated according to usual clinical practice, who meet the criteria to participate in the study, read the corresponding information sheet, sign informed consent and agree to participate, provided they meet the following inclusion criteria:
- Age ≥ 18 years. In case of minors, they may be included, under the following assumptions:
- If the minor is under 12 years of age, participation will require the consent and signature of the informed consent document by both parents (or their guardian).
- If the minor is between 12 and 16 years of age, a proxy informed consent form will be provided and signed by both parents (if both parents are present at the time of the interview) or only one of them (in which case one of the following two conditions must be stated: that the other parent is not present at the time of the interview but does not object to the participation of the minor in the study or that the signatory is the sole legal guardian of the minor).
- Be registered or potentially/have been attended in the Extremadura Health Service.
Key exclusion criteria (3 listed)
- Failure to meet any of the inclusion criteria described above.
- Refusal by the patient to be part of the cohort initially, or to continue to be part of the cohort during follow-up.
- Manifest difficulty for follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service.
Time frame: December 2024
To analyze the implementation in the clinical routine of a pharmacogenetics and personalized medicine program in SES patients, evaluating the overall impact on the health system, and at the individual level, general modifications in the clinical response and its temporal evolution.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 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.
Complejo Hospitalario Universitario de Badajoz
Badajoz, Spain
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 Adverse Drug Event, run by Complejo Hospitalario Universitario de Badajoz at 1 site in Spain.
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 7 inclusion and 3 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 23 Sep 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 Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service. (time frame: December 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 23 Sep 2024.