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Tuberculosis clinical trials

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NCT ID: NCT01554384 Completed - Tuberculosis Clinical Trials

Trial of Point-of-treatment Xpert MTB/RIF Assay

TBNEATXpert
Start date: October 2010
Phase: N/A
Study type: Interventional

Xpert MTB/RIF assay is a novel automated molecular tool for the diagnosis of TB. Xpert can detect TB genetic material in sputum samples as well as test for genetic resistance to rifampicin providing results within 2 hours. Xpert received WHO endorsement in December 2010. There is limited data on the impact of Xpert on time-to-treatment and TB-related patient morbidity in primary care clinics. No studies have yet evaluated Xpert performed at the point-of-treatment (POT) i.e. in primary care clinic location. The investigators hypothesize that one sputum GeneXpert MTB/RIF assay performed at the POT will improve time-to-diagnosis, time-to-treatment and TB related patient morbidity for patients with suspected TB presenting to primary level TB clinics in high HIV prevalent settings.

NCT ID: NCT01547884 Completed - Tuberculosis Clinical Trials

Effect of Filarial Infection on Immune Responses in Latent Tuberculosis

Start date: January 1, 2013
Phase:
Study type: Observational

Background: - Lymphatic filariasis is an infection that is caused by small, thread-like worms. It is spread by mosquitoes, and causes fever, chills, and headaches. If untreated, it can also cause elephantiasis, a condition that leads to swelling of the arms, legs, breasts, and scrotum. Treatment can eliminate the worms from the blood and reduce the risk of developing elephantiasis. Researchers want to study people with latent tuberculosis (TB) who may or may not be infected with filariasis. This study will look at the way that people with latent TB fight infection with these worms. Objectives: - To study how the immune systems of people with latent TB react to filarial infection. Eligibility: - Individuals between 18 and 65 years of age who have latent TB and may or may not have filarial infection. Design: - Participants will be screened with a physical exam and medical history. They will provide a blood and stool sample to test for infection. - Participants who do not have lymphatic filariasis but have another kind of intestinal worm will be treated for the parasite. This will be their last study visit. - Participants who have latent TB and lymphatic filariasis will be treated with the standard treatment for the disease. They will come back for a second visit 6 months later, and will provide another blood sample.

NCT ID: NCT01545661 Completed - Tuberculosis Clinical Trials

Utility of Sputum Induction and Novel Technologies to Improve TB Diagnosis in a High HIV Prevalence Primary Care Setting

SINET
Start date: August 2009
Phase: N/A
Study type: Interventional

This study will investigate the benefit of using Sputum induction for TB diagnosis in a primary care clinic for adult TB suspects that are either unable to produce a sputum sample (sputum scarce) or on initial diagnostic work-up have 2 negative sputum smear samples (WHO standard for frontline TB diagnosis). The investigators hypothesize that acquiring an induced sputum sample for smear microscopy and liquid TB culture will decrease time-to-diagnosis and time-to-treatment initiation in smear negative/sputum scarce TB patients in a primary care clinic in a resource-limited high TB HIV prevalent setting.

NCT ID: NCT01539005 Completed - Tuberculosis Clinical Trials

Tuberculosis Recurrence Upon Treatment With Highly Active Antiretroviral Therapy

TRuTH
Start date: November 2009
Phase: N/A
Study type: Observational

This is a cohort observational study investigating the rate of tuberculosis (TB) recurrence in adult patients who have completed TB therapy for Pulmonary TB (PTB) and are on highly active antiretroviral therapy (HAART).The primary objective of this study is to determine the incidence of TB recurrence in patients on HAART.The study is being conducted at the CAPRISA eThekwini Clinical Research Site (CRS), which is adjacent to the Prince Cyril Zulu Communicable Disease Clinic (PCZCDC), a major urban TB clinic, in Durban, South Africa.No hypotheses will be tested in this study; however, the primary study question will determine the proportion of TB recurrence due to relapse vs. re-infection.The study has enrolled 402 participants

NCT ID: NCT01530568 Completed - Tuberculosis Clinical Trials

Gene Xpert Diagnosis of TB Using Tracheal Aspirates From Intensive Care Unit (ICU) Patients

Start date: August 2010
Phase: N/A
Study type: Interventional

Aim: To evaluate the diagnostic utility and impact on patient outcomes of an automated PCR (Gene Xpert® MTB/RIF), in a group of patients with suspected pulmonary TB who are mechanically ventilated in ICU, using tracheal aspirates. Hypothesis: Gene Xpert is an accurate tool for the diagnosis of TB in the Intensive Care Unit and will impact on rates of treatment initiation and hospital stay.

NCT ID: NCT01521364 Completed - Clinical trials for Extensively Drug-resistant Tuberculosis

Drug Interaction Study Between Linezolid and Clarithromycin in Tuberculosis Patients

Start date: December 2011
Phase: Phase 4
Study type: Interventional

Future patients might benefit from a combination of linezolid (LIN) and clarithromycin (CLA) in the treatment of Multidrug-resistant and Extensively Drug-resistant Tuberculosis (MDR/XDR-TB) due to possible synergistic activity as shown in in vitro experiments in different Mycobacteria strains. The investigators observed increased LIN serum levels in three cases after combining LIN and CLA of which the investigators described one in a case report (Bolhuis et al). The investigators suggest to conduct a prospective pharmacokinetic study in MDR- and XDR-TB patients to quantify the above described interaction between LIN and CLA.

NCT ID: NCT01517022 Completed - Tuberculosis Clinical Trials

Intensive Smoking-cessation Intervention Versus Smoking-cessation Advice in Smear-positive Patients With Pulmonary Tuberculosis

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The aim of the study is to determine the impact of a package of smoking-cessation interventions on a composite measure of Tuberculosis (TB) treatment-related outcomes. Given the lack of objective clinical data/evidence about the impact of smoking-cessation on TB-related outcomes, yet subjective expert opinion that smoking cessation is highly likely to be beneficial particularly in patients with TB, this study proposes to determine the impact of an intensive package of smoking-cessation interventions aimed to promote smoking-cessation (counseling plus nicotine replacement therapy, NRT), on patient response to anti-tuberculosis therapy. This is to be compared with the structured counselling for smoking-cessation that is recommended to be routinely provided by health care workers to all patients who are smokers. If the results prove that such a smoking-cessation PI indeed improves outcomes in TB patients, such information would strongly motivate for the institution of more intensive smoking-cessation interventions in TB clinics than is currently being employed for TB patients

NCT ID: NCT01516203 Completed - Tuberculosis Clinical Trials

Phase 2a EBA Trial of AZD5847

Start date: December 5, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the early bacterial activity (EBA) from day 0 to day 14 of Astra Zeneca Drug (AZD5847) at four different doses and schedules (500 mg once daily, 500 mg twice daily, 1200 mg once daily, and 800 mg twice daily) in subjects with newly-diagnosed sputum smear positive pulmonary TB. A total of 75 subjects will be enrolled, with 15 randomized to each AZD5847 study arm or standard treatment with Rifafour. Duration of drug treatment is 14 days.

NCT ID: NCT01498419 Completed - Clinical trials for Pulmonary Tuberculosis

Evaluation of 8 Weeks of Treatment With the Combination of Moxifloxacin, PA-824 and Pyrazinamide in Patients With Drug Sensitive and Multi Drug-Resistant Pulmonary Tuberculosis (TB) (NC-002)

Start date: March 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the mycobactericidal activity of the moxifloxacin plus PA-824 plus pyrazinamide regimen after 8 weeks of treatment.

NCT ID: NCT01497769 Completed - Tuberculosis Clinical Trials

Safety of Tuberculosis Vaccine, MVA85A, Administered by the Aerosol Route and the Intradermal Route

Start date: September 2011
Phase: Phase 1
Study type: Interventional

This is a phase I trial to compare the safety and immunogenicity of candidate TB vaccine MVA85A administered by the aerosol inhaled route and the intradermal route in healthy BCG-vaccinated adult subjects.