Advertisement

Topics

Tuberculosis in China

2014-08-27 03:15:48 | BioPortfolio

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.

Description

Despite optimal antimicrobial treatment with directly observed short-course therapy (DOTS), about 5-10 percent of drug-compliant patients with cured tuberculosis (TB or MTB) relapse, usually within a year after completion of therapy. This percentage is even greater for patients that have previously been treated for TB who often are infected with multi-drug resistant (MDR) and extensively drug resistant (XDR) organisms. The People's Republic of China has the second highest number of cases of TB in the world, with a rate of 101 cases/100,000 person-years estimated for 2004. Based on the data of the 4th national TB epidemiological survey in 2000, it is estimated that there were 1.96 million instances of pulmonary TB. With an established MDR TB prevalence of 10.7 percent, there were an estimated 209,720 cases of pulmonary, bacteriology confirmed MDR TB in China in 2000. About half of all prevalent cases of TB disease in 2000 were extrapulmonary.

This prospective longitudinal natural history study will monitor 150 subjects with suspected TB at the Henan Provincial Chest Hospital during their initial response to antituberculous chemotherapy. The subjects will be divided into 3 groups of TB-infected individuals: Cohort A) acid-fast bacilli (AFB) smear positive pulmonary disease; Cohort B) smear negative pulmonary disease; and Cohort C) extra-pulmonary disease (EPTB) in order to reflect the spectrum of TB manifestations observed at Henan Provincial Chest Hospital. We will also be enrolling 25 non-TB suspects as controls (Cohort D). The control group will serve as a comparison group for exploratory immunologic and diagnostic assays that may, in the future, serve as ways to diagnose TB and/or evaluate response to therapy.

In this exploratory study, we will be looking at the change in total volume of disease as detected by computerized tomography scans of the chest at baseline, at 2 months, and at 6 months. We will also be looking at scanned regions of extrapulmonary TB. In addition, we will monitor chemotherapeutic regimen, changes in the host immune response, overall changes in clinical parameters, initial and acquired drug-resistance of the infecting isolates, and changes in bacterial and host markers in subject samples during chemotherapy. In each case, we will look for associations of these parameters with rates of disease resolution correlated with specific structural features determined by computerized tomography scanning of the sites of TB disease (with the exception of TB meningitis and cutaneous TB, for which there are no specific lesions to follow radiographically). These studies will allow us to evaluate the use of entry criteria in future clinical trials and eventual TB diagnosis confirmation using these entry categorizations. We will also be able to examine the impact of initial regimen selection, and subsequent modifications, mycobacterial strain characteristics, extent of disease, types of lesions and host immunologic response to the overall outcome of chemotherapy, as well as potentially identify surrogate markers for improving monitoring of the response to chemotherapy.

Study Design

Time Perspective: Prospective

Conditions

Tuberculosis

Location

Henan Provincial Chest Hospital
Zhengzhou
China
450003

Status

Recruiting

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:48-0400

Clinical Trials [328 Associated Clinical Trials listed on BioPortfolio]

Diagnosing Tuberculosis in HIV Infected Children in Peru

Tuberculosis is a major cause of mortality among AIDS patients in the developing world. The diagnosis of tuberculosis in HIV infected children is complicated by inefficient and expensive ...

Expression of Tuberculosis in the Lung

The purpose of this study is to assess lung immune responses in patients with active pulmonary tuberculosis (TB) and in healthy control persons who are exposed to Mycobacterium tuberculosi...

Improving the Diagnostic of Tuberculosis

The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis. Hypothesis 10% of patients infected by M. tuberculosis are carrier of M. tub...

Pulmonary Tuberculosis and Vitamin D

Tuberculosis and vitamin D deficiency are important public health problems in India. Before the advent of effective antitubercular therapy, patients with tuberculosis were advised treatme...

The Optimal Duration of Preoperative Anti-tuberculosis Treatment of Spinal Tuberculosis

The purpose of this study is to determine the better preoperative anti-tuberculosis treatment period of patients with spinal tuberculosis.

PubMed Articles [887 Associated PubMed Articles listed on BioPortfolio]

Localized hepatic tuberculosis presenting as severe hypercalcemia.

Hypercalcemia might present itself in association with granulomatous diseases such as tuberculosis. We report a rare case of a 62-year-old man with hypercalcemia due to hepatic tuberculosis. The diagn...

Novel M. tuberculosis specific IL-2 ELISpot assay discriminates adult patients with active or latent tuberculosis.

Tuberculosis (TB) still is a major worldwide health problem, with 10.4 million new cases in 2016. Only 5-15% of people infected with M. tuberculosis develop TB disease while others remain latently inf...

Convergent evolution and topologically disruptive polymorphisms among multidrug-resistant tuberculosis in Peru.

Multidrug-resistant tuberculosis poses a major threat to the success of tuberculosis control programs worldwide. Understanding how drug-resistant tuberculosis evolves can inform the development of new...

Effectiveness of Canada's tuberculosis surveillance strategy in identifying immigrants at risk of developing and transmitting tuberculosis: a population-based retrospective cohort study.

In Canada, tuberculosis disproportionately affects the foreign-born population. The national tuberculosis medical surveillance programme aims to prevent these cases. Individuals referred for further i...

First case of sexual transmitted asymptomatic female genital tuberculosis from spousal epididymal tuberculosis diagnosed by active screening.

Tuberculosis screening was performed for a healthy asymptomatic woman to determine whether she had been infected with active genital tuberculosis via sexual intercourse with her husband who had epidid...

Medical and Biotech [MESH] Definitions

The dormant form of TUBERCULOSIS where the person shows no obvious symptoms and no sign of the causative agent (Mycobacterium tuberculosis) in the SPUTUM despite being positive for tuberculosis infection skin test.

Tuberculosis of the brain, spinal cord, or meninges (TUBERCULOSIS, MENINGEAL), most often caused by MYCOBACTERIUM TUBERCULOSIS and rarely by MYCOBACTERIUM BOVIS. The infection may be limited to the nervous system or coexist in other organs (e.g., TUBERCULOSIS, PULMONARY). The organism tends to seed the meninges causing a diffuse meningitis and leads to the formation of TUBERCULOMA, which may occur within the brain, spinal cord, or perimeningeal spaces. Tuberculous involvement of the vertebral column (TUBERCULOSIS, SPINAL) may result in nerve root or spinal cord compression. (From Adams et al., Principles of Neurology, 6th ed, pp717-20)

Pathological conditions of the CARDIOVASCULAR SYSTEM caused by infection of MYCOBACTERIUM TUBERCULOSIS. Tuberculosis involvement may include the HEART; the BLOOD VESSELS; or the PERICARDIUM.

TUBERCULOSIS that involves any region of the GASTROINTESTINAL TRACT, mostly in the distal ILEUM and the CECUM. In most cases, MYCOBACTERIUM TUBERCULOSIS is the pathogen. Clinical features include ABDOMINAL PAIN; FEVER; and palpable mass in the ileocecal area.

Tuberculosis of the mouth, tongue, and salivary glands.

More From BioPortfolio on "Tuberculosis in China"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Infectious-diseases
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...


Searches Linking to this Trial