NCT04963660

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

July 6, 2021

Last Update Submit

July 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (6)

  • characterization of immunodeficient patients

    1 year

  • Concordances between clinical manifestations and literature

    1 year

  • organic complications

    1 year

  • type and degree of immunodeficiency

    1 year

  • pathonges that cause infectious

    1 year

  • +1 more secondary outcomes

Eligibility Criteria

Age12 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • All patients from adult primary immunodeficiency clinics will be included.

You may not qualify if:

  • Patients with HIV
  • Proven secondary immunodeficiencies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Calderon Guardia

San José, 00000, Costa Rica

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 15, 2021

Study Start

November 11, 2018

Primary Completion

November 11, 2019

Study Completion

November 11, 2019

Last Updated

July 15, 2021

Record last verified: 2021-07

Locations