Tuberculosis Clinical Trial
Official title:
A Natural History Study of Tuberculosis in China; Correlates of a Successful Response to Treatment
Verified date | January 29, 2018 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
- In spite of well-researched treatments and therapies, 5 to 10 percent of tuberculosis (TB)
patients who have initially successful TB treatments will relapse, usually within a year
after completion of therapy. This percentage is even greater for patients who are infected
with multi-drug resistant and extensively drug resistant types of TB. Because the People s
Republic of China has the second highest number of TB cases in the world, researchers are
interested in studying TB patients in China to evaluate their response to treatment on a
long-term basis.
Objectives:
- To improve TB diagnosis and testing by determining the number and proportion of patients
admitted with suspected TB who actually have TB (definite or probable).
- To assess the prevalence of non-tuberculosis bacteria among patients with presumed TB.
Eligibility:
- Individuals between 18 and 65 years of age who have been admitted to Henan Provincial Chest
Hospital with suspected tuberculosis.
Design:
- Participants will be divided into three groups, based on their diagnosis after
admission. Another group of individuals who do not have TB will be enrolled as controls
for comparison purposes during the study.
- The study will use computed tomography (CT) scans of the chest at initial enrollment, 2
months, and 6 months to evaluate disease response to treatment. Incidents of TB that are
not in the chest area (extrapulmonary TB) will also be studied.
- The study will also monitor the treatments and therapies used against the disease,
changes in patients immune systems, and any changes in the biological samples taken over
the course of treatment.
Status | Completed |
Enrollment | 199 |
Est. completion date | January 29, 2018 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
- INCLUSION CRITERIA: A subject must fulfill all inclusion criteria within his or her assigned cohort in order to be eligible to participate in this study. Smear Positive TB (Cohort A) - Age 18-65 years old - Sputum AFB-smear positive (at least 1 positive smears out of 3) and exhibiting the signs or symptoms suggestive of pulmonary MTB disease - If presently on anti-TB chemotherapy, having a regimen which started not more than 14 days prior to enrollment (please see note below) - If previously treated for TB, having been off of anti-TB chemotherapy for at least 60 days before starting present regimen, or before enrollment if not presently on drugs - Willingness to adhere to study visits and testing - Willingness to have samples stored Smear Negative TB (Cohort B) - Age 18-65 years old - Sputum AFB-smear negative (zero out of 3) and exhibiting the signs or symptoms suggestive of pulmonary MTB disease - If presently on anti-TB chemotherapy, having a regimen which started not more than 14 days prior to enrollment (please see note below) - If previously treated for TB, having been off of anti-TB chemotherapy for at least 60 days before starting present regimen, or before enrollment if not presently on drugs - Willingness to adhere to study visits and testing - Willingness to have samples stored - Subjects with the above criteria who cannot expectorate and cannot produce sputum by induction Extra Pulmonary TB (Cohort C) - Age 18-65 years old - Exhibiting the signs and symptoms suggestive of MTB EP disease If presently on anti-TB chemotherapy, having a regimen which started not more than 14 days prior to enrollment (please see note below) - If previously treated for TB, having been off of anti-TB chemotherapy for at least 60 days before starting present regimen, or before enrollment if not presently on drugs - Willingness to adhere to study visits and testing - Willingness to have samples stored Controls (Cohort D): - Age 18-65 years old - No signs or symptoms of an active TB infection - Willingness to adhere to study visit and testing - Willingness to have samples stored EXCLUSION CRITERIA: A subject will be excluded from this study if he or she meets any of the following exclusion criteria from their assigned cohort. Also, potential participants may be excluded from the study on the basis of the investigator s judgment concerning the ability to comply with study procedures or posing an undue risk to the subject. Cohort C Only Evidence of pulmonary TB (If subject at enrollment is suspected to have both pulmonary TB and extrapulmonary TB, then s/he will be enrolled into Cohort A or B) Cohort D (Controls) - Those with signs or symptoms consistent with TB disease - Women who report themselves to be pregnant or those found to be pregnant by a urine beta-HCG test during the protocol introduction and consent process; - Those having a chest X-ray suggestive of active tuberculosis - Use of immunosuppressive agents such as corticosteroids, TNF blocking agents, cyclosporine, methotrexate, or mycophenolate at entry - Body mass index (BMI) <16 - History of systemic lupus erythematosus, rheumatoid arthritis, or other connective tissue disease - The use of any of the following drugs within 30 days prior to study or anticipated use of these drugs within the next 60 days: - Systemic cancer chemotherapy - Systemic corticosteroids - Immune globulin - Interleukins - Interferons - Those with malignancies Cohort A-C Scan Exclusions The following will still be included in the study; however they will be excluded from the CT scanning (enrollment and follow-up) only: - Those who are pregnant - Those with a creatinine greater than 150 UL within 14 days of a scheduled CT scan (enrollment or follow-up) Note that if subjects excluded by these above criteria for a study-related CT scan still require a CT scan because of medical necessity, the results of the CT scan will be collected by the study. |
Country | Name | City | State |
---|---|---|---|
China | Henan Provincial Chest Hospital | Zhengzhou |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
China,
He GX, Zhao YL, Jiang GL, Liu YH, Xia H, Wang SF, Wang LX, Borgdorff MW, van der Werf MJ, van den Hof S. Prevalence of tuberculosis drug resistance in 10 provinces of China. BMC Infect Dis. 2008 Dec 11;8:166. doi: 10.1186/1471-2334-8-166. — View Citation
Wallis RS. Surrogate markers to assess new therapies for drug-resistant tuberculosis. Expert Rev Anti Infect Ther. 2007 Apr;5(2):163-8. — View Citation
Xianyi C, Fengzeng Z, Hongjin D, Liya W, Lixia W, Xin D, Chin DP. The DOTS strategy in China: results and lessons after 10 years. Bull World Health Organ. 2002;80(6):430-6. — View Citation
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