NCT00695734

Brief Summary

This study aims to compare the performance of the tuberculin skin test, used for more than 50 years as a diagnostic tool for latent tuberculosis infection, with 2 blood tests which have recently become commercially available (Interferon-gamma release assays) in a population of immunosuppressed individuals with chronic renal failure undergoing long term hemodialysis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2007

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

January 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
Last Updated

June 12, 2008

Status Verified

June 1, 2008

Enrollment Period

1 year

First QC Date

June 10, 2008

Last Update Submit

June 10, 2008

Conditions

Chronic Renal Failure

Keywords

hemodialysisend stage renal failuretuberculosislatent tuberculosis infectionPatients under hemodialysis for end stage renal failure

Outcome Measures

Primary Outcomes (1)

  • Relative performance of tuberculin skin test and interferon gamma release assays for detecting latent tuberculosis infection

    cross-sectionnal

Secondary Outcomes (1)

  • Agreement between tuberculin skin test and interferon gamma release assays as well as agreement between interferon gamma release assays

    cross-sectionnal

Study Arms (1)

Hemodialysis

Patients under chronic hemodialysis for chronic end stage renal failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged over 18 Under hemodialysis for \> 3 months End stage renal failure

You may qualify if:

  • Adults aged over 18
  • Under hemodialysis for \> 3 months
  • End stage renal failure

You may not qualify if:

  • Refusal to participate
  • Prior tuberculin skin test \> 15 mm or any adverse reaction to tuberculin skin test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospital

Geneva, Geneva 14, 1211, Switzerland

Location

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency, ChronicTuberculosisLatent Tuberculosis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent Infection

Study Officials

  • Jean-Paul Janssens, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 10, 2008

First Posted

June 12, 2008

Study Start

January 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

June 12, 2008

Record last verified: 2008-06

Locations

CH(1)