- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
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Taipei, Taiwan, 100
- Rekrytering
- National Taiwan University Hospital
-
Huvudutredare:
- Chin-Chung Shu, MD
-
Kontakt:
- Chin-Chung Shu, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
occurrence of active tuberculosis
Tidsram: 2 years
|
2 years
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Latent tuberculosis infection
Tidsram: 2 years
|
2 years
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Chin-Chung Shu, MD, National Taiwan University Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 201110013RC
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