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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01685086
First received: September 11, 2012
Last updated: September 12, 2012
Last verified: November 2011
  Purpose

To follow-up the latent tuberculosis infection and evaluate the risk of developing active tuberculosis in patients with severe chronic kidney disease or receiving long-term dialysis


Condition
To Determine the Prevalence of Latent Tuberculosis in Each Group
To Monitor the Occurrence of Active Tuberculosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • occurrence of active tuberculosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Latent tuberculosis infection [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: March 2012
Groups/Cohorts
Patients with severe chronic kidney disease
Patient with peritoneal dialysis
Patients with hemodialysis

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The patients with severe chronic kidney disease or long term dialysis

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685086

Contacts
Contact: Chin-Chung Shu, MD 886972653087 ccshu139@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Chin-Chung Shu, MD         
Principal Investigator: Chin-Chung Shu, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chin-Chung Shu, MD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01685086     History of Changes
Other Study ID Numbers: 201110013RC
Study First Received: September 11, 2012
Last Updated: September 12, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
latent tuberculosis infection, tuberculosis, chronic kidney disease, peritoneal dialysis, hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Tuberculosis
Renal Insufficiency, Chronic
Latent Tuberculosis
Urologic Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Renal Insufficiency

ClinicalTrials.gov processed this record on August 26, 2014