Trial Title

Clinical Study

A5307  A Phase IIA Open label, Randomized Clinical Trial evaluating the Essentiality of Isoniazid in Tuberculosis Therapy
A5312 A Phase IIA Open label, Randomized Clinical Trial Examining the early Bactericidal Activity of High-Dose or Standard-Dose Isoniazid among Adult Patients with Isoniazid-Resistant or Drug-Sensitive Tuberculosis
Astra Zeneca   (DMID 11-0006) A   Randomized, Open Label, Multiple Dose, Phase IIA Study of the Early   Bactericidal Activity of AZD5847 in Adults with, Pulmonary Tuberculosis
Ball Study Early treatment response in smear-positive and smear-negative / GeneXpert positive   adult TB patients with HIV co-infection
C-037-456 A  Phase I, Double-blind, Randomized, Placebo-controlled, Dose-escalation Study   to Evaluate the Safety and Immunogenicity of AERAS-456 in HIV Negative Adults  Successfully Treated for Drug-susceptible Pulmonary Tuberculosis
C041-972 Sub-study   for GSK Protocol TB-018:Collection and Storage of Biological Samples for   Evaluation of Correlates of Tuberculosis
HighRif A   Phase IIA Dose Ranging Trial to Evaluate the Safety, Tolerability, Extended   Early Bactericidal Activity and Pharmacokinetics of Higher Doses of   Rifampicin in Adult Subjects with Newly Diagnosed, Uncomplicated,   Smear-Positive, Pulmonary Tuberculosis.
LIN-CL001 A   Phase 2 Dose-ranging Trial to Evaluate the Bactericidal Activity, Safety,   Tolerability and Pharmacokinetics of Linezolid in Adult Subjects with Newly   Diagnosed Drug-Sensitive, Smear Positive Pulmonary Tuberculosis
MAMS A   multiple arm, multiple stage (MAMS), phase 2, open label, randomized,   controlled clinical trial to evaluate four treatment regimens including   SQ109, two increased doses of rifampicin, and moxifloxacin in adult subjects   with newly diagnosed, smear‐positive pulmonary tuberculosis
NC-001-(J-M-Pa-Z) A   Phase II Trial to Evaluate the Early Bactericidal Activity, Safety and   Tolerability of the following: TMC207 alone, TMC207 plus pyrazinamide, PA-824   plus pyrazinamide and PA-824 plus pyrazinamide and moxifloxacin, in Adult   Patients with Newly Diagnosed, Smear-Positive Pulmonary Tuberculosis
NC-002-(M-Pa-Z) A   Phase II Open-Label Partially Randomized Trial to Evaluate the Efficacy,   Safety and Tolerability of the combination of moxifloxacin plus PA-824 plus   pyrazinamide after 8 weeks of treatment in Adult Patients with Newly   Diagnosed Drug-Sensitive or Multi Drug-Resistant, Smear-Positive Pulmonary   Tuberculosis
NC-003-(C-J-Pa-Z) A   Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and   Tolerability of the following: TMC207 plus PA-824 plus pyrazinamide plus   clofazimine, TMC207 plus PA-824 plus pyrazinamide, TMC207 plus PA-824 plus   clofazimine, TMC207 plus pyrazinamide plus clofazimine, pyrazinamide alone,   and clofazimine alone; in Adult Patients with Newly Diagnosed, Smear-Positive   Pulmonary Tuberculosis.
NC-005 A   Phase 2 Open-Label Partially Randomized Trial to Evaluate the Efficacy,   Safety and Tolerability of combinations of bedaquiline, moxifloxacin, PA-824   and pyrazinamide during 8 weeks of treatment in Adult Subjects with Newly   Diagnosed Drug-Sensitive or Multi Drug-Resistant, Smear-Positive Pulmonary   Tuberculosis.
NC-006-(M-Pa-Z) A   Phase 3 Open-Label Partially Randomized Trial to Evaluate the Efficacy,   Safety and Tolerability of the Combination of Moxifloxacin plus PA-824 plus   Pyrazinamide after 4 and 6 months of Treatment in Adult Subjects with   Drug-Sensitive Smear-Positive Pulmonary Tuberculosis and after 6 months of   Treatment in Adult Subjects with Multi-Drug Resistant, Smear-Positive   Pulmonary Tuberculosis.
NTP Biobanking Clinical   Trial 101: Creation of a   Biorepository for Testing Potential Surrogate Markers of Treatment Success in   TB (Biobanking Study).
Opti Q Prospective,   Randomized, Blinded Phase 2 Pharmacokinetic/    Pharmacodynamic Study of the Efficacy and Tolerability of Levofloxacin   in Combination with Optimized Background Regimen (OBR) for the treatment of   MDR-TB.
Otsuka A   Phase 3, Multicenter, Randomized, Double-blind, Placebo controlled, Parallel   Group Trial to Evaluate the Safety and Efficacy of Delamanid (OPC-67683)   administered orally as 200mg Daily dose for Six Months in Patients with   Pulmonary Sputum Culture-positive, Multi-drug-resistant Tuberculosis.
PA-824-CL-007
PA-824-CL-010 A   Phase II Dose Ranging Trial to Evaluate the Extended Early Bactericidal   Activity, Safety, Tolerability, and Pharmacokinetics of PA-824 in Adult   Participants with Newly Diagnosed, Uncomplicated, Smear-Positive,   Pulmonary Tuberculosis. Protocol Number: PA-824-CL-010.
Pfizer   (B1171003) A   Phase 2A, Open-Label, Randomized Study in Treatment-Naïve, Sputum Smear   Positive Subjects With Drug-Sensitive Pulmonary Tuberculosis to Assess Early   Bactericidal Activity (EBA) and Whole Blood Activity (WBA) of PNU-100480   (PF-02341272)
REMox-TB A   randomised placebo – controlled double blind trial comparing two treatment   shortening regimens with the standard regimen (two months ethambutol,   isoniazid, rifampicin and pyrazinamide followed by four months isoniazid and   rifampicin) namely 1) two months moxifloxacin, isoniazid, rifampicin and   pyrazinamide followed by two months moxifloxacin, isoniazid and rifampicin   and 2) two months ethambutol, moxifloxacin, rifampicin and pyrazinamide   followed by two months moxifloxacin and rifampicin for the treatment of   adults with pulmonary tuberculosis
SQ-109   (LMU-IMPH-SQ109-01) A   Phase IIA Trial to Evaluate the Extended Early Bactericidal Activity, Safety,   Tolerability and Pharmacokinetics of SQ109 in Adult Participants with Newly   Diagnosed, Uncomplicated, Smear-Positive, Pulmonary Tuberculosis
Task001 A   phase 2 trial to evaluate the early bactericidal activity, safety and   tolerability of meropenem, administered intravenously, plus   amoxycillin/clavulanic acid and faropenem, administered orally, plus   ampicillin/clavulanic acid in adult patients with newly diagnosed,   smear-positive pulmonary tuberculosis.
TB-018 A   phase IIb, double-blind, randomised, placebocontrolled study to evaluate the   efficacy, safety and immunogenicity of GSK Biologicals’ candidate   tuberculosis (TB) vaccine GSK 692342 against TB disease, in adults aged 18-50   years, living in a TB endemic region.
TBTC29 Evaluation   of a rifapentine-containing regimen for intensive phase treatment of   pulmonary tuberculosis. TBTC 29.
TBTC29X Evaluation of a   rifapentine-containing regimen for intensive phase treatment of pulmonary   tuberculosis
TESEC-05 A   phase III trial in subjects suspected to have TB, comparing the diagnostic   outcome of C-Tb to QuantiFERON®-TB Gold In-Tube, in combination with a double   blind randomized split body safety assessment of C-Tb versus 2 T.U.   Tuberculin PPD RT23 SSI (PPD).
TESEC-07 A   double blind randomized phase II/III trial in adult patients recently   diagnosed with active TB investigating if concomitant injections of the   diagnostic agents C-Tb and 2T.U Tuberculin PPD RT23 SSI 9 (PPD) affect the   induration responses in combination with safety assessment of C-Tb
TMC207-CL001 A   Phase II Dose Ranging Trial to Evaluate the Extended Early Bactericidal   Activity, Safety, Tolerability, and Pharmacokinetics of TMC207 in Adult   Patients with Newly Diagnosed, Uncomplicated, Smear-Positive,   Pulmonary Tuberculosis.
TMC208   (TMC207-TiDP13-C208) A   Phase II, placebo-controlled, double-blind, randomized trial to evaluate the   anti-bacterial activity, safety, and tolerability of TMC207 in subjects with   sputum smear-positive pulmonary infection with multi-drug resistant   Mycobaterium tuberculosis (MDR-TB)
TMC209   (TMC207-TiDP13-C209) A   Phase II, open-label trial with TMC207 as part of a multi-drug resistant   tuberculosis (MDR-TB) treatment regimen in subjects with sputum   smear-positive pulmonary infection with MDR-TB