
Heterologous Effects of BCG in Healthy UK Adults
TuberculosisTB038 is a clinical study to assess the non-specific effects of BCG vaccination and gain a better understanding of how the body's immune system reacts to BCG and in turn potentially prevents infection from other bacteria.

Biological Samples Obtained by Leukapheresis Induced by Two BCG Vaccinations in BCG-naïve Healthy...
TuberculosisThis protocol will use leukapheresis to collect lymphocytes to study immune responses following vaccination with BCG in BCG-naïve participants. These studies will include, but not necessarily be limited to: anti-T-cell and anti-Natural Killer (NK) T-cell responses, anti-lipid responses, and antibody responses to BCG following re-vaccination. These responses will provide a detailed framework characterizing the immune responses that are induced and responses that are not induced in humans by BCG, a partially protective TB vaccine. This framework will allow new hypotheses to be formulated and tested regarding what new and more effective TB vaccines should target for optimal protective immunity.

The Impact of Alcohol Consumption on Tuberculosis Treatment Outcomes
TuberculosisAlcohol Consumption1 moreAfter HIV/AIDS, tuberculosis (TB) remains the second leading cause of death due to an infectious disease globally. Retrospective studies from many countries, including the United States and South Africa, have consistently reported that in addition to having a higher burden of TB disease, patients with problem alcohol use have worse TB treatment outcomes. This prospective study will attempt to clarify both behavioral and biologic causal mechanisms underlying the deleterious effects of problem alcohol use on TB treatment response.

Quality of Tuberculosis Care in Urban Patna, India
TuberculosisThe purpose of this study is to evaluate the impact of the Private Provider Interface Agency (PPIA) program on quality of health care. The PPIA is a tuberculosis pilot program implemented in the private health sector of urban Patna in the state of Bihar, India.

Quality of Tuberculosis Care in Mumbai, India
TuberculosisThe purpose of this study is to evaluate the impact of the Private Provider Interface Agency (PPIA) program on quality of care. The PPIA is a tuberculosis pilot program implemented in the private health sector of Mumbai city, India.

Start TB Patients on ART and Retain on Treatment (START Study)
TuberculosisHIVThe purpose of the START Study is to identify an effective, cost-effective, acceptable intervention that addresses programmatic, structural and psychosocial barriers to ART initiation and retention during TB treatment, with the ultimate goal of improving health outcomes among HIV-infected TB patients in Lesotho. The study is a two-arm cluster randomized trial, randomized at the TB/HIV clinic level, which includes twelve TB/HIV clinics in Berea district. Clinics are randomized to deliver the combination intervention package (CIP) or standard of care (SOC), with stratification by facility type. The experimental intervention will be delivered to all HIV-infected TB patients in TB/HIV clinics randomly assigned to CIP. In TB/HIV clinics assigned to SOC, usual care procedures for ART initiation and retention will be delivered. Study hypotheses focus on the effectiveness of the CIP on HIV- and TB-related outcomes. Compared to HIV-infected TB patients attending SOC clinics, HIV-infected TB patients at CIP clinics will have superior HIV- and TB-related outcomes, including: Greater ART initiation during TB treatment Shorter time to ART initiation Greater retention in ART care Higher adherence to ART Greater change in CD4+ count Greater TB treatment success (completion and cure) Greater sputum smear conversion Higher adherence to TB treatment Additionally, CIP delivery will have an incremental cost-effectiveness ratio more favorable than alternative resource uses.

Replacement of Vitamin D in Patients With Active Tuberculosis
TuberculosisPulmonaryTuberculosis is a global public health problem. One third of the world's population is infected with tuberculosis (TB) with almost 2 million deaths per year globally. According to the WHO, Pakistan ranks 8th amongst the 22 high TB burden countries, with an estimated prevalence is 263 cases /100,000 populations. In spite of effective therapy for drug sensitive TB, treatment failure occurs frequently leading to concerns for the emergence of multi-drug resistant (MDR) and extensively drug resistant (XDR) mycobacterial strains. Therefore in the recent years, interest has been generated regarding the role of adjuvant immunomodulating therapy for the treatment of TB. WHO has classified tuberculosis by disease severity into 3 distinct categories; mild, moderate and severe according to clinical presentations and host factors. Severity of disease has been linked to mycobacterium genotypes and with host factors such as vitamin D deficiency Vitamin D is a hormone produced by the body in response to sun exposure. Independent of it's effects on bone mineralization, vitamin D is recognized to have numerous immune modulating effects; some specific to mycobacterium tuberculosis. Therefore vitamin D may enhance the host immune responses against the pathogen. Vitamin D status can be accurately determined by measuring the serum levels of 25-(OH) D3. A recent systemic review and meta-analysis explored the association between low serum vitamin D and risk of active tuberculosis and concluded that patients with tuberculosis have lower serum levels of vitamin D than healthy controls when matched for sex, age, ethnicity, diet and geographical location. Vitamin D deficiency is not a life threatening condition. It usually is unrecognized or can present with generalized 'aches and pains' due to osteomalacia. The recommended dose for treatment of vitamin D deficiency is 200,000 IU/ month or 50,000 IU/ week, both given for 2 months or until the serum vitamin D level is > 30 ng/ml. Bone mineral density changes are usually completed by 10 weeks of treatment. The investigators hypothesize that by replacing vitamin D in patients with active pulmonary tuberculosis, the 'Time to Recovery' can be shortened.Our aims are to determine whether replacing patients with insufficient and deficient levels of vitamin D affects the clinical outcome of the disease.

Measurement of Anti-TB Drugs in Lung Tissue From Patients Having Surgery to Treat Tuberculosis
TuberculosisThis study, conducted jointly by researchers at the National Masan TB Hospital, Asan and Samsung Medical Centers in Seoul, Republic of Korea, and the Yonsei University and the NIH in the United States, will examine why some patients with tuberculosis (TB) develop disease that is harder to treat than most cases. TB is an infection of the lung that usually can be successfully treated with anti-TB drugs. However, some people get a more serious kind of disease (called multi-drug resistant TB or extensively drug-resistant TB) that is very difficult to treat and may not be cured by the regular medicines available. This study will try to find out if some of the common TB drugs are getting to the place where the TB bacteria are. It will also look at how current anti-TB drugs might be used more effectively and how better drugs might be developed. People 20 years of age and older with hard-to-treat TB who have elected to undergo surgical removal of part of their lung at the National Masan Tuberculosis Hospital, Masan, the Asan Medical Center, and the Samsung Medical Center, may be eligible for this study. Participants undergo the following procedures: Medical history and physical examination, including sputum sample. Blood tests at various times during the study. Drug administration. Subjects are given one dose each of five common TB drugs rifampicin, isoniazid, pyrazinamide, kanamycin and moxifloxacin before they undergo surgery to remove part of their lung. After surgery, some of the lung tissue and fluid around the lungs that was removed during surgery will be examined to determine the regions where the TB bacteria live and analyze the lung tissue itself. Dynamic MRI (magnetic resonance imaging) scan. This type of scan uses a magnetic field and radio waves to produce pictures of the lung. Subjects lie very still on a table inside the cylindrical scanner with their head on a soft cradle and their hands over their head. Several images are obtained for less than 5 minutes at a time.

Effect of Community Mobile Outreach Approach Compared to Facility Based Directly Observed Treatment...
TuberculosisTo compare the effectiveness of the community mobile outreach approach in improving treatment outcomes (success rate) among tuberculosis patients with those being treated with facility based directly observed treatment short course (DOTS) in Jeddah region.

The Effect of Telephone Follow-up and Training on Treatment Adherence in Tuberculosis Patients and...
TuberculosisTuberculosis (TB) is a preventable and curable disease mostly affecting lungs and caused by the bacteria called as Mycobacterium Tuberculosis (MTB). It is estimated that approximately 10 million people are diagnosed with TB every year in the world and 1.7 billion people are infected by MTB and at risk in terms of the development of the disease. Contacted person is the one who shares the same environment with the patient suffering from contagious TB and is exposed to MTB bacilli. Today, the aim of the TB control and prevention programs is to determine the active TB patients and provide cure by healing and also to screen those contacted with the TB patients and determine whether or not they have latent TB infection and treat them and to detect the active cases among the contacts. In the current guidelines, the importance of screening all the contacts of the patients with pulmonary TB and applying a protective treatment for the household in terms of community health care is emphasised. For this reason, it is of prime importance to perform contact screening of the relatives of the TB patients and apply protective treatment. The patients receiving TB and TB protection treatment need to use medicine regularly for at least six months. It is highly important to adherence this period for the success of the treatment. However, it has been reported in the literature that the rate of nonadherence to the TB treatment varies between 20-80% and the nonadherence to the TB treatment is the most serious barrier in the control of the disease. İncomplete treatment may result in long-lasting infection, drug resistance, relapse, and death. In the litareture, it has been stated in the study conducted with the individuals with some chronic diseases that tele-follow-up is effective in providing the self-care agency of patients and the cognitive-social adaptation. It has been reported that some problems emerge especially in the TB patients such as the interruption of treatment, forgetting medication (24.5%), side-effects of drugs, (23.3%), symptomatic recovery (19.5%), failure to know the necessity of completing the life cycle of drugs by most of patients and not receiving adequate training and these problems may be managed more effectively by tele-follow-up. As is known, nurses are involved in all the processes of protecting-promoting the health of the individuals, families and society and their recovery in case of disease. Moreover, providing the protective treatment by performing the required screening for treating TB patients, their follow-up and preventing the development of disease in contacted ones has a vital importance in preventing the spread of TB in the society. Nurses may follow the findings of patients, obtain information about the process, produce information and transmit information with this system (reporting drug changes, performing training follow-up of patients etc.). In the literature, it has been emphasised that tele-mobile nursing services is a cost-effective method since it decreases the hospitalisation rate and period of the TB patients. Accordingly, the main aim of this study is to assess the effect of the training and the telephone follow-up provided by the nurse for the TB patients and contacts on the medication adherence.