TASK advances clinical and microbiological research by performing clinical trials to evaluate novelty pharmaceuticals for its treatment effects.

Current Trials:

STUDY NUMBER                       PROTOCOL TITLE  Status
A5243 Plan for Obtaining Human Biological Samples at Non-US Clinical Research Sites for Currently Unspecified Genetic Analyses Open For Enrollment
A5312 The Early Bactericidal Activity of High-Dose or Standard-Dose Isoniazid among Adult Patients with Isoniazid-Resistant or Drug-Sensitive Tuberculosis. Open For Enrollment
A5343 A Trial of the Safety, Tolerability and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, among Participants Taking Multidrug Treatment for Drug-Resistant Pulmonary Tuberculosis. Open For Enrollment
A5349 Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial Open For Enrollment
AP-TB-201-16 (ALOPEXX) A Phase 2 Open-label Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of F598, a Humanized Anti-poly-N-acetyl Glucosamine Monoclonal Antibody, in Adults with Latent Tuberculosis or Newly Diagnosed, Smear-Positive Pulmonary Tuberculosis Enrollment completed
CQVM149B2301 A multi-center, randomized, 52 week treatment, double-blind, triple dummy, parallel- group study to assess the efficacy and safety of QMF149 compared with mometasone furoate in patients with asthma Enrollment completed
CQVM149B2303 A multi-center, randomized, 12-week treatment, double-blind study to assess the efficacy and safety of QMF149 (150/80 microgram) compared with MF Twisthaler® (200 microgram) in adult and adolescent patients with asthma Open For Enrolment
FD-R-05724 A Phase 2a Study of the Early Bactericidal Activity of Rifampin in Combination with Meropenem plus Amoxicillin/Clavulanate Among Adults with Rifampin-Resistant or Rifampin-Susceptible Pulmonary Tuberculosis Open For Enrolment
PanACEA-RUNMC-HR1 (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. Enrollment completed
NC005 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. Completed
NIX-TB (J-L-PA-Z) A Phase 3 open-label trial assessing the safety and efficacy of bedaquiline plus PA-824 plus linezolid in subjects with pulmonary infection of either extensively drug-resistant tuberculosis (XDR-TB) or treatment intolerant/ non-responsive multi-drug resistant tuberculosis (MDR-TB). Final Phase
Predict Using Biomarkers to Predict TB Treatment Open For Enrolment
R475-OA-1611 A Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo and Naproxen-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients with Pain Due to Osteoarthritis of the Knee or Hip Open For Enrolment
RSV-M-301 A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study To Determine The Immunogenicity And Safety Of A Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum In Healthy Third-Trimester Pregnant Women; And Safety And Efficacy Of Maternally Transferred Antibodies In Preventing RSV Disease In Their Infants On hold
TASK-003 A Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of Meropenem Administered Intravenously Once or Twice Daily in Combination with Oral Amoxicillin/Clavulanate, Ertapenem Administered Once Daily Intravenously or Intramuscularly with Oral Amoxicillin/Clavulanate, Oral Amoxicillin/Clavulanate Alone, and Rifampicin with Oral Amoxicillin/Clavulanate in Adults with Newly Diagnosed, Smear-Positive Rifampicin-Susceptible Pulmonary Tuberculosis. Open For Enrolment
TB-018 (115616 ) A phase IIb, double-blind, randomised, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of GSK Biologicals’ candidate tuberculosis (TB) vaccine GSK 692342 against TB disease, in healthy adults aged 18-50 years, living in a TB endemic region. Follow Up Phase
 A-052  

Determining viability of sputum for Mycobacterium tuberculosis culture after long term storage at -80°C.

 

 Open to enrolment
RIFoMETER-1  

Transcutaneous Rifampicin Concentration Monitoring

 

  Open to enrolment
Q203-TB-P2-ZA001  An Open-label Randomized Study to Evaluate the Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203) in Treatment-naïve Patients with Newly Diagnosed Drug-sensitive Sputum Smear-positive Pulmonary Tuberculosis

 

  Open to enrolment

Upcoming:

STUDY NUMBER PROTOCOL TITLE 

A-055

A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of H56:IC31 in Reducing the rate of TB Disease Recurrence in HIV Negative Adults Successfully Treated for Drug-Susceptible Pulmonary Tuberculosis.
201214 A Phase IIa open-label trial to investigate the early bactericidal activity, safety and tolerability of GSK3036656 in participants with drug-sensitive pulmonary tuberculosis.
A5300B/I2003B/PHOENIx Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB).
UMCN-AKF-17.05 – UMCN-AKF-17.05 – The effect of high dose rifampicin on the activity of cytochrome P450 enzymes and P-glycoprotein in patients with pulmonary tuberculosis: a cocktail phenotyping study.
TB-OWL-1 A pilot study to determine the feasibility of developing software to detect and count coughs, and to determine their potential use as a biomarker in tuberculosis
323-201-00003 A Phase 1/2, Active-controlled, Randomized, Open-label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Multiple Oral Doses of OPC-167832 Tablets in Subjects with Uncomplicated, Smear-positive, Drug-susceptible Pulmonary Tuberculosis