NCT03618147

Brief Summary

  • Background/Rationale: Epidemiological data about Primary Immunodeficiency Disorders (PIDD) in Kuwait is needed to better understand peculiarities and to compare them with other regions and ethnicity.
  • Study hypothesis: PIDD is relatively common in Kuwait compared to populations from different geographic areas. The distribution of PIDD in Kuwait is different from other geographic areas with more severe forms being more frequent.
  • Brief inclusion and exclusion criteria of study participants: PIDD patients presented at different clinics/hospital in Kuwait. Patients with secondary immunodeficiencies (drug induced, virus induced, and immunodeficiency associated with metabolic disorders... ect), will be excluded
  • Estimated sample size of the study: All patients who were registered in KNPIDR since 2004 will be included in the study along with the new patients who will be recruited during the study period.
  • Primary objectives:
  • Determine the prevalence and frequency of different PIDD in Kuwait
  • Identify clinical presentation patterns for PIDD in Kuwait
  • Identify natural history of PIDD in Kuwait
  • Help to asses epidemiology of PIDD in Kuwait
  • Determine particularities about PIDD affecting the population in Kuwait
  • Determine the health impact of PIDD in Kuwait
  • Development of strategies to improve the care and the quality of life of patients with PIDD

Trial Health

87
On Track

Trial Health Score

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

Enrollment
314

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2018

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
4 months until next milestone

Results Posted

Study results publicly available

September 4, 2019

Completed
Last Updated

September 9, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

July 30, 2018

Results QC Date

May 10, 2019

Last Update Submit

September 5, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Different Epidemiological Features

    15 years

  • Number of Overall and New Cases of PID Per 100,000 Kuwaitis

    15 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PIDD patients in Kuwait

You may qualify if:

  • PIDD patients presented at different clinics/hospital in Kuwait

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Deprtmemt, Alsabah hospital

Kuwait City, Kuwait

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Kuwait Society of Allergy & Clinical Immunology
Organization
Kuwait Society of Allergy & Clinical Immunology

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 7, 2018

Study Start

July 16, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

September 9, 2019

Results First Posted

September 4, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations