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Tuberculosis clinical trials

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NCT ID: NCT01778062 Completed - Clinical trials for Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis

Indacaterol EfectIveness In COPD Patients With Tuberculosis History

INFINITY
Start date: February 2013
Phase: Phase 3
Study type: Interventional

This clinical study will assess efficacy and safety of indacaterol (150㎍ o.d.) in patients with Chronic Obstructive Pulmonary Disease (COPD) with destroyed lung by tuberculosis.

NCT ID: NCT01770730 Completed - Tuberculosis Clinical Trials

A Trial of the Urine LAM Strip Test for TB Diagnosis Amongst Hospitalized HIV-infected Patients

LAMRCT
Start date: January 2013
Phase: N/A
Study type: Interventional

The novel urine LAM point-of-care strip test offers potential clinical utility to improve TB diagnosis in HIV co-infected patients. Urine LAM strip test performance improves with increasing illness severity and more advanced immunosuppression, thus offering the greatest potential utility in hospitalised HIV-infected patients with advanced immunosuppression (CD4 cell count less than 200). However, in the context of high rates of empiric treatment and the availability of other novel TB diagnostics, the clinical impact of the urine LAM strip test is unknown. This study will investigate the impact of the urine LAM strip test. The study hypothesis is that the urine LAM strip test, when combined with standard TB diagnostics (smear microscopy and culture) will significantly improve TB treatment-related outcomes (TB-related mortality, morbidity and length of hospital stay) in HIV-infected hospitalized patients when compared to standard TB diagnostics alone.

NCT ID: NCT01768273 Completed - Tuberculosis Clinical Trials

Evaluation of the Pharmacokinetic Interaction Between PA-824 and Midazolam

Start date: December 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of PA-824 when given with a single dose of midazolam, and to determine whether PA-824 inhibits CYP3A to a clinically important degree as measured by the effect of PA-824 on the pharmacokinetics of midazolam, a known CYP3A substrate.

NCT ID: NCT01766830 Completed - HIV Clinical Trials

Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases In Patients With Persistent Fever in Cambodia, Nepal, Democratic Republic of the Congo and Sudan (NIDIAG-Fever)

Start date: January 2013
Phase: N/A
Study type: Interventional

Tropical fevers have been a diagnostic challenge from the antiquity. Nowadays, despite the availability of good diagnostic capacities, undifferentiated febrile illnesses continue to be a thorny problem for travel physicians. In developing countries, the scarcity of skilled personnel and adequate laboratory facilities makes the differential diagnosis of fevers even more complex. Health care workers must often rely on syndrome-oriented empirical approaches to treatment and might overestimate or underestimate the likelihood of certain diseases. For instance Neglected Tropical Diseases (NTD) contribute substantially to the burden of persistent (more than 1 week) fevers in the Tropics, causing considerable mortality and major disability. These diseases are however rarely diagnosed at primary health care (PHC) level. The difficulty in establishing the cause of febrile illnesses has resulted in omission or delays in treatment, irrational prescriptions with polytherapy, increasing cost and development of drug resistance. In resource-limited settings, clinical algorithms constitute a valuable aid to health workers, as they facilitate the therapeutic decision in the absence of good laboratory capacities. There is a critical lack of appropriate diagnostic tools to guide treatment of NTDs. While clinical algorithms have been developed for some NTDs, in most cases they remain empirical. Besides, they rarely take into account local prevalence data, do not adequately represent the spectrum of patients and differential diagnosis at the primary care level and often have not been properly validated. The purpose of the study is to develop evidence-based Rapid Diagnostic Test (RDT)-supported diagnostic guidelines for patients with persistent fever (≥ 1 week) in the Democratic Republic of the Congo (DRC), Sudan, Cambodia and Nepal.

NCT ID: NCT01761201 Terminated - Clinical trials for Latent Tuberculosis Infection

"Efficacy and Safety of Levofloxacin vs Isoniazid in Latent Tuberculosis Infection in Liver Transplant Patients".

FLISH-ILT
Start date: January 2012
Phase: Phase 3
Study type: Interventional

A multicenter, prospective, non-inferiority, randomized and open clinical trial comparing levofloxacin with isoniazid in the treatment of latent tuberculosis infection in patients eligible for liver transplantation. Patients over 18 years of age on the waiting list for liver transplantation. Sample size: n=870 patients. HYPOTHESIS Levofloxacin treatment of latent tuberculosis infection, begun while on the waiting list for liver transplantation, is safer and not less effective than isoniazid treatment begun after transplantation when liver function is stable.

NCT ID: NCT01755598 Completed - Tuberculosis Clinical Trials

Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults

Start date: August 19, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the protective efficacy of two doses of GSK Biologicals' candidate TB vaccine against pulmonary TB, as compared to placebo. The efficacy will be evaluated in adults living in TB endemic countries and aged 18 - 50 years because pulmonary TB occurs frequently in these countries and age range. In addition, the safety and immunogenicity of the candidate tuberculosis vaccine will be evaluated in a subset of volunteers.

NCT ID: NCT01751568 Completed - HIV Infections Clinical Trials

Safety, Tolerance and Pharmacokinetics of Raltegravir-Containing Antiretroviral Therapy in Infants, Children Infected With HIV and TB

Start date: November 12, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

People who are infected with HIV and tuberculosis (TB) need to receive medications that treat both diseases safely and effectively. This study enrolled infants and children infected with HIV and TB and evaluated the safety and tolerance of an antiretroviral (ARV) treatment regimen for HIV that contains raltegravir when administered with a TB treatment regimen that includes rifampicin. Study researchers aimed to determine the most effective dose of raltegravir for infants and children when taken with rifampicin.

NCT ID: NCT01748357 Completed - Tuberculosis Clinical Trials

Siemens VOC TB Pilot Study

Start date: December 2012
Phase: N/A
Study type: Observational

Tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide. Diagnosis of the disease is often time consuming or challenging. Many cases of tuberculosis require advanced and expensive diagnostic methods that restrict their availability in resource limited countries where the burden of tuberculosis is highest. The development of rapid point of care diagnostics is required. Published data confirm that trained African giant-pouched rats are able to identify M. tuberculosis cultures through olfactory recognition. A first trial using an electronic nose reported a rate of detection of 85% in tuberculosis patients. A further trial was closed in June 2011 but remains unpublished, yet. The olfactory pattern that potentially allows the recognition of tuberculosis remains unknown. This trial aims to detect first patterns of volatile organic compounds (VOCs) that bear a potential for further development and fine tuning. A technical prototypic device of Siemens is used for pattern detection. The study is comparing 3 groups of patients: - patients with confirmed active pulmonary tuberculosis (n=20) - patients with other inflammatory lung diseases (pneumonia, sarcoidosis, COPD, bronchial carcinoma) (n=20) - healthy volunteers that do not work in the hospital or visit the hospital regularly Detailed data for all study subjects will be collected for this trial in order to eliminate confounding factors. Furthermore, detailed data of the surroundings of the patient, the surroundings of the technical device and of the operator will be captured. Hypothesis: The pattern of exhaled volatile organic compounds allows the detection of pulmonary tuberculosis

NCT ID: NCT01742364 Completed - Tuberculosis Clinical Trials

Comparative Study of Bacille Calmette Guerin (BCG) Delivery Via Disposable Syringe Jet Injector and Needle & Syringe

Start date: December 2012
Phase: N/A
Study type: Interventional

The study is designed to test the hypothesis that BCG administration via jet injector will produce a comparable immune response and that there will be no significant differences in safety or reactogenicity between BCG administration via jet injector and needle and syringe. The primary objectives of this study are to... 1. Compare the safety and reactogenicity of BCG administered intradermally by a jet injector device in adults and infants, to BCG administered intradermally by needle and syringe; 2. Compare the specific T cell immunity in neonates vaccinated with BCG via the jet injector device to infants vaccinated with BCG via needle and syringe.

NCT ID: NCT01724723 Not yet recruiting - Tuberculosis Clinical Trials

Using Entecavir to Reduce Hepatitis in Highly Viremic HBV Patients During Anti-tuberculous Treatment

HBV
Start date: December 2012
Phase: Phase 4
Study type: Interventional

Hepatitis during anti-tuberculous treatment (HATT) has been an obstacle in managing TB patients, especially in those with viral hepatitis. A previous study revealed the risk of HATT is significantly higher in TB patients with high serum hepatitis B virus (HBV) DNA level than those with low HBV DNA level. Based on these findings, we thus hypothesize that the risk of HATT in TB patients with high baseline serum HBV DNA level can be reduced by concomitant use of anti-HBV agent. In this proposal, we will conduct a prospective randomized clinical study to assess the reduction of HATT risk by using entecavir in TB patients with high baseline serum HBV DNA level, and to evaluate the risk of other treatment-related adverse events in two hospitals.