- ICH GCP
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- Klinische proef NCT01685086
Surveillance and Follow-up for Latent Tuberculosis Infection and Observation of the Effect of Prophylactic Latent Tuberculosis Treatment in Patients With Severe Chronic Kidney Disease or Receiving Long-term Dialysis
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Tuberculosis (TB) remains an important infectious disease worldwide. Taiwan is still an edemic area. In 2008, there is an incidence of 62 persons having TB per 100,000 population. To control TB, we should prevent further TB transmission via early diagnosis and treatment of latent TB. In screening the risk population for TB, patients with renal failure acquiring long-term dialysis, in addition to close contacts, have higher incidence and mortality than general population. Moreover, the risk for active TB in dialysis patients is ten to 25 times larger. In Taiwan, the dialysis group is important because it has higher prevalence (2228 per in per million people by 2009 annual report of United States Renal Data System) than other countries in the world. In particular, the dialysis patients usually has an extrapulmonary presentation for their TB, so diagnosis is always delay. Hence, we should detect latent TB in those dialysis patients for monitor them from active tuberculosis.
Currently, interferon-gamma release assays (IGRAs) are used for finding out those with latent TB and have been proven useful for those being immunocompromised, and having BCG vaccination. For dialysis patients, IGRAs have been tested and been considered better than skin tuberculin test. However, previous studied rarely observed the patients receiving peritoneal dialysis and severe chronic kidney disease. Besides, those cross-sectional studies used the indirect evidence for diagnosis and lacked longitudinal follow-up. We thus conducted this study for observing the prevalence of latent TB in those receiving hemodialysis or peritoneal dialysis by using IGRAs. We also kept follow-up for the primary outcome of active TB occurrence.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Taipei, Taiwan, 100
- Werving
- National Taiwan University Hospital
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Hoofdonderzoeker:
- Chin-Chung Shu, MD
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Contact:
- Chin-Chung Shu, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- older than 20 years old
- Estimated CCr < 30 ml/min as group of severe chronic kidney disease
- Long-term (>3months) dialysis as dialysis group
Exclusion Criteria:
- refusal of recruitment
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Patients with severe chronic kidney disease
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Patient with peritoneal dialysis
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Patients with hemodialysis
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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occurrence of active tuberculosis
Tijdsspanne: 2 years
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2 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Latent tuberculosis infection
Tijdsspanne: 2 years
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2 years
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Chin-Chung Shu, MD, National Taiwan University Hospital
Studie record data
Bestudeer belangrijke data
Studie start
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 201110013RC
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