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Completed

NCT Number: NCT00695734

Detection of Latent Tuberculosis in Hemodialysis Patients

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

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Key information

Conditions

Chronic Renal Failure Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gram-Positive Bacterial Infections Infections Kidney Diseases Kidney Failure, Chronic Latent Infection Latent Tuberculosis Male Urogenital Diseases Mycobacterium Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Tuberculosis Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geneva University Hospital

Geneva, Geneva 14, 1211, Switzerland

About this study

This prospective study includes all adults aged over 18 years of age who accept to be included in the study and provided written informed consent. All patients are under long term hemodialysis for chronic renal failure. They are subjected to a questionnaire including history of contacts with tuberculosis (TB), prior treatment for TB, history of prior tuberculin skin testing, history of BCG vaccination, country of origin, trips or prolonged stays in high incidence areas, smoking history, and medications. All patients will have a chest X-ray, and simultaneous testing with the tuberculin skin test according to the Mantoux technique, and with the T-SPOT. TB and QuantiFERON Gold in tube Interferon-gamma release assays. The study analysis agreement between tests, detection of prior TB and presumptive latent tuberculosis infection, based on these items.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: cross-sectionnal

Secondary outcomes

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

    Time frame: cross-sectionnal

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • Ligue Pulmonaire Genevoise

Registry information

Official study title

Interferon-Gamma Release Assays (IGRA) Versus Tuberculin Skin Testing for Detection of Latent Tuberculosis Infection (TB) in Chronic Hemodialysis Patients

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 12, 2008
Registry last updated
Jun 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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