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Tuberculosis, Pulmonary clinical trials

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NCT ID: NCT03822156 Completed - Tuberculosis Clinical Trials

Clinical Analysis of the Patients With Cavitary Pulmonary TB and Endobronchial TB in the PPM-UUH Cohort

Start date: January 1, 2010
Phase:
Study type: Observational [Patient Registry]

This study is a retrospective cohort study. The purpose of this study is to investigate clinical features of the patients with the cavitary pulmonary tuberculosis (TB) and endobronchial TB from the patients who have been registered in this hospital for treatment and follow-up, as part of the "PPM Project (Private-Public Mix project) for Korean National Tuberculosis Control" introduced in Korea since 2007.

NCT ID: NCT03776500 Completed - Clinical trials for Tuberculosis, Pulmonary

Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PBTZ169 in Multiple Dosing

Start date: February 21, 2019
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, multiple ascending dose study conducted at one study center in Switzerland. Four (4) panels (A, B, C and D) of 8 male subjects (6 active and 2 placebo) each receiving multiple doses of PBTZ169 or a matching placebo, at increasing dose levels, once or twice daily. Subjects will participate in only one panel. Blocks of 4 subjects (3 under active treatment, 1 under placebo) will be investigated in parallel. Panels will start sequentially. Safety will be assessed throughout the study; serial ECGs and serial blood samples will be collected for the safety and PK assessment of PBTZ169. Dose escalation will be allowed once the Trial Safety Board has determined that adequate safety and tolerability after each panel completion has been demonstrated to permit proceeding to the next panel. In addition, a preliminary assessment of the drug interaction potential of PBTZ169 will be done by the measurement of inhibition or induction of human cytochromes through the metabolism of microdoses of standard probe substrates

NCT ID: NCT03758612 Completed - Tuberculosis Clinical Trials

A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults

Start date: January 16, 2019
Phase: Phase 1
Study type: Interventional

Partially-Blinded, Placebo-Controlled, Randomized, Single Ascending Dose (SAD) with a Food Effect Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults.

NCT ID: NCT03732014 Withdrawn - Clinical trials for Tuberculosis, Pulmonary

Bronchial Washings in Sputum Scarce Cases of Pulmonary Tuberculosis

Start date: January 2, 2019
Phase:
Study type: Observational

This study will be conducted in Ojha Institute of Chest Diseases and Department of Medicine, Dow Medical College, Karachi both affiliated with Dow University of Health Sciences, Karachi, Pakistan after IRB approval. All patients of either gender with clinical suspicion of PTB on history, examination and CXR and not expectorating sputum or less than 1 ml will be included in the study. Patients with extra pulmonary tuberculosis, those with age < 12 years will be excluded. Demographic data of selected patients including age, gender, contact with PTB patient will be collected. Data will be entered in study proforma. Selected patients will undergo bronchoscopy using Olympus 180 series video bronchoscope. Bronchial Wash will be done and 3 aliquots of BW samples will be collected by suctioning. One part of washing will be immediately inoculated in AFB Culture media and second will be submitted for Xpert MTB/RIF testing. Third part will be centrifuged, and sediment will be subjected to AFB microscopy after staining with Ziehl-Neelsen technique. Results of microscopy and Xpert MTB/RIF will be collected next day, and treatment will be started if MTB comes positive, while results of AFB Culture will be collected after 6 weeks and treatment will be started if not already started on previous reports. Sensitivity/Resistance pattern will be recorded for both Xpert MTB/RIF and ABF Culture. The sample size of 72 was taken for conduct of study. Sample size calculations were done using PASS software version 15.0. Frequency of positive tests will be calculated. Mean age will be calculated according to gender and compared by Student's t-test. Sensitivity & specificity of tests will be calculated using online calculator by VassarStats. Frequency of positive yield of Xpert MTB/RIF will be compared to that of microscopy by χ2- test. P-value of <0.05 was considered significant.

NCT ID: NCT03728725 Completed - Clinical trials for Tuberculosis, Pulmonary

Xpert MTB/XDR Clinical Evaluation Trial

Start date: July 11, 2019
Phase:
Study type: Observational

FIND and partners intend to address the need for a multi- and extensively drug-resistant tuberculosis (M/XDR-TB) diagnostic solution for patients in settings with a high burden of drug-resistant tuberculosis (DR-TB) though the development, evaluation and introduction of an Xpert MTB/XDR assay

NCT ID: NCT03722472 Completed - Pulmonary TB Clinical Trials

Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults

Start date: October 2, 2018
Phase: Phase 1
Study type: Interventional

This is a phase 1, double-blind, randomized clinical trial to evaluate the safety, tolerability, and immunogenicity of single-vial lyophilized ID93 + GLA-SE compared to the two-vial presentation consisting of lyophilized ID93 and liquid GLA-SE administered as two IM injections in healthy adult subjects (aged 18 - 55).

NCT ID: NCT03712709 Completed - Clinical trials for Tuberculosis, Pulmonary

Clinical Evaluation of the Truenat Point-of-care Tuberculosis Diagnostic Test

Start date: March 12, 2019
Phase:
Study type: Observational

Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis will be interviewed for demographic and medical information, and then will be asked to provide 3-4 expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis and rifampin resistance.

NCT ID: NCT03702738 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Adjunctive NAC in Adult Patients With Pulmonary Tuberculosis

NAC-TB
Start date: March 1, 2019
Phase: Phase 2
Study type: Interventional

To determine if adjunctive N-acetylcysteine 1200 mg twice a day (BID) accelerates sputum culture conversion and normalization of cellular glutathione in tuberculosis (TB), and to assess its potential effects on lung and immune function

NCT ID: NCT03678688 Completed - Pulmonary TB Clinical Trials

A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis

Start date: October 18, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This trial will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of multiple oral doses of OPC-167832 in participants with uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis (TB).

NCT ID: NCT03590600 Completed - Tuberculosis Clinical Trials

A Single Ascending Dose Study of BTZ043

Start date: June 7, 2018
Phase: Phase 1
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics of single doses of BTZ043 in healthy adult volunteers. The study is conducted at a study centre in Germany. Up to 50 male and female participants will be included in this study in up to 5 cohorts; each cohort will consist of 10 subjects: in each cohort 8 subjects will be assigned to BTZ-043 and 2 to placebo. The doses tested will be: 125mg, 250mg, 500mg, 1000mg and 2000mg. Safety will be assessed via regular vital sign measurement, 12-lead ECG parameters, physical examination and safety laboratory assessments. Subjects will be hospitalized from Day -1 until discharge in the morning of Day 3. After completion of all Day 3 assessments of a cohort, blinded safety data will be reviewed and the next dose increment will be decided by the Trial Steering Committee (TSC).