Tuberculosis in China

NCT01071603 | Completed

• 2 other identifiers: 99991006010-I-N060
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tuberculosis; Tuberculosis, Multidrug-Resistant; Extensively Drug Resistant Tuberculosis

Keywords

Biomarkers; Extrapulmonary TB; NTM; HRCT; MDRTB; Tuberculosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Henan Provincial Chest Hospital

Zhengzhou, 450003, China

Location

Related Publications (4)

• 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.

  PMID: 19077223 BACKGROUND

• 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.

  PMID: 12131998 BACKGROUND

• Wallis RS. Surrogate markers to assess new therapies for drug-resistant tuberculosis. Expert Rev Anti Infect Ther. 2007 Apr;5(2):163-8. doi: 10.1586/14787210.5.2.163. No abstract available.

  PMID: 17402829 BACKGROUND

• Trauner A, Liu Q, Via LE, Liu X, Ruan X, Liang L, Shi H, Chen Y, Wang Z, Liang R, Zhang W, Wei W, Gao J, Sun G, Brites D, England K, Zhang G, Gagneux S, Barry CE 3rd, Gao Q. The within-host population dynamics of Mycobacterium tuberculosis vary with treatment efficacy. Genome Biol. 2017 Apr 19;18(1):71. doi: 10.1186/s13059-017-1196-0.

  PMID: 28424085 DERIVED

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Multidrug-Resistant; Extensively Drug-Resistant Tuberculosis; Tuberculosis, Extrapulmonary

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Clifton E Barry, Ph.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: February 2, 2010
• Study Completion: January 29, 2018
• Last Updated: April 5, 2018

Record last verified: 2018-01-29

Locations

CN (1)