Primary Immune Deficiency in AdultsNCT04963660
Primary Immunodeficiencies in Costa Rican Adults
An observational study of Primary Immune Deficiency in Adults, run by Caja Costarricense de Seguro Social at 1 site in Costa Rica.
Trial summary
Primary immunodeficiencies represent a underdiagnosed group of rare diseases which if diagnosed well and in time can be treated in an efficient manner and prevent complications that may affect the quality of patients life in an severe manner. Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Primary Immune Deficiency in Adults
- How many people
- 137 participants
- Where
- 1 siteCosta Rica
- Study dates
- 11 Nov 2018to 11 Nov 2019
- 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 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All cases of primary immunodeficiency and idiopathic defects of immunity detected in the primary immunodeficiency clinics of the Hospitals Mexico and Dr. Rafael Ángel Calderón Guardia between November 2017 and May 2018.
Who may be able to join
- All patients from adult primary immunodeficiency clinics will be included.
Who cannot join
- Patients with HIV
- Proven secondary immunodeficiencies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CASE SERIES OF PRIMARY IMMUNODEFICIENCIES IN ADULTS DIAGNOSED IN TWO HOSPITALS OF THE TERTIARY LEVEL OF CARE OF THE COSTA RICAN SOCIAL SECURITY Fund, 2017-2018
Primary immunodeficiencies represent a underdiagnosed group of rare diseases which if diagnosed well and in time can be treated in an efficient manner and prevent complications that may affect the quality of patients life in an severe manner. Neither in Costa Rica nor in Central America studies or national registries regarding the prevalence and characterization of primary immunodeficiencies in adult patients exist up to now. This study reflects for the first time the epidemiologic situation of primary immunodeficiencies in a Central American country, characterizing adult patients diagnosed with primary and idiopathic immune disorders treated in two specialized immunodeficiency clinics in Costa Rica.
- Conditions
- Primary Immune Deficiency in Adults
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical manifestations of all adult patients diagnosed with primary and idiopathic immune defects
Describe the clinical manifestations of all adult patients diagnosed with primary and idiopathic immune defects attended in the primary immunodeficiency clinics of the Hospitals Mexico and Dr. Rafael Ángel Calderón Guardia during the study period.
Measured: 1 year
Secondary outcomes (6)
characterization of immunodeficient patients
Characterize immunodeficient patients using sociodemographic and health variables.
Measured: 1 year
Concordances between clinical manifestations and literature
•Establish concordances between the clinical manifestations of the group of patients under study with those described in the literature according to the different pathologies.
Measured: 1 year
organic complications
Record organic complications secondary to immunodeficiency status.
Measured: 1 year
type and degree of immunodeficiency
Differentiate the type and degree of immunodeficiency of each patient.
Measured: 1 year
pathonges that cause infectious
Report isolated pathogens that cause infectious manifestations in patients.
Measured: 1 year
bacteria present in upper airways
•Report the colonizing bacteria present in the cultures of the upper airways of the patients requested in the initial approach.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start11 Nov 2018
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune Deficiency in AdultsStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 137 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Caja Costarricense de Seguro Social
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963660
- Sponsor's protocol ID
- R017-SABI-00148.
- Status last verified
- Jul 2021
- First submitted
- 6 Jul 2021
- Last updated
- 15 Jul 2021
- 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 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CASE SERIES OF PRIMARY IMMUNODEFICIENCIES IN ADULTS DIAGNOSED IN TWO HOSPITALS OF THE TERTIARY LEVEL OF CARE OF THE COSTA RICAN SOCIAL SECURITY Fund, 2017-2018
- ClinicalTrials.gov ID
- NCT04963660
- Acronym / sponsor ID
- R017-SABI-00148.
- Conditions
- Primary Immune Deficiency in Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Caja Costarricense de Seguro SocialOther government
- Study start
- 11 Nov 2018 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 15 Jul 2021 (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.
Primary immunodeficiencies represent a underdiagnosed group of rare diseases which if diagnosed well and in time can be treated in an efficient manner and prevent complications that may affect the quality of patients life in an severe manner. Neither in Costa Rica nor in Central America studies or national registries regarding the prevalence and characterization of primary immunodeficiencies in adult patients exist up to now. This study reflects for the first time the epidemiologic situation of primary immunodeficiencies in a Central American country, characterizing adult patients diagnosed with primary and idiopathic immune disorders treated in two specialized immunodeficiency clinics in Costa Rica.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All cases of primary immunodeficiency and idiopathic defects of immunity detected in the primary immunodeficiency clinics of the Hospitals Mexico and Dr. Rafael Ángel Calderón Guardia between November 2017 and May 2018.
Key inclusion criteria (1 listed)
- All patients from adult primary immunodeficiency clinics will be included.
Key exclusion criteria (2 listed)
- Patients with HIV
- Proven secondary immunodeficiencies.
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
Clinical manifestations of all adult patients diagnosed with primary and idiopathic immune defects
Time frame: 1 year
Describe the clinical manifestations of all adult patients diagnosed with primary and idiopathic immune defects attended in the primary immunodeficiency clinics of the Hospitals Mexico and Dr. Rafael Ángel Calderón Guardia during the study period.
6 secondary outcomes
characterization of immunodeficient patients
Time frame: 1 year
Concordances between clinical manifestations and literature
Time frame: 1 year
organic complications
Time frame: 1 year
type and degree of immunodeficiency
Time frame: 1 year
pathonges that cause infectious
Time frame: 1 year
bacteria present in upper airways
Time frame: 1 year
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 15 Jul 2021.
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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 Primary Immune Deficiency in Adults, run by Caja Costarricense de Seguro Social at 1 site in Costa Rica.
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 1 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 15 Jul 2021. 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 Costa Rica. 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?
Clinical manifestations of all adult patients diagnosed with primary and idiopathic immune defects (time frame: 1 year). 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 15 Jul 2021.