C-006
- Conditions
- Tuberculosis
- Registration Number
- PACTR201408000858108
- Lead Sponsor
- Global Alliance for TB Drug Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 1500
1.Signed written consent or witnessed oral consent in the case of illiteracy, prior to undertaking any trial-related procedures.
2.Male or female, aged 18 years or over.
3.Body weight (in light clothing and no shoes) ¿ 30 kg.
4.Sputum positive for tubercule bacilli (at least 1+ on the IUATLD/WHO scale (Appendix 1)) on smear microscopy at the trial laboratory.
5.Drug-Sensitive TB treatment arms subjects should be:
a.sensitive to rifampicin by rapid sputum based test (may be sensitive or resistant to isoniazid) AND
b.either newly diagnosed for TB or have a patient history of being untreated for at least 3 years after cure from a previous episode of TB.
If they are entered into the trial due to being sensitive to rifampicin by rapid sputum based test, however on receipt of the rifampicin resistance testing using an indirect susceptibility test in liquid culture this shows they are rifampicin resistant, they will be:
a.Excluded as late exclusions;
b.Possibly replaced as determined by the sponsor.
MDR-TB treatment arm subjects should be resistant to rifampicin by rapid sputum based test (may be sensitive or resistant to isoniazid).
6.A chest x-ray which in the opinion of the investigator is compatible with pulmonary TB.
7.Be of non-childbearing potential or using effective methods of birth control.
1.Any non TB related condition that could compromise the well-being of the subject.
2.Being or about to be treated for Malaria.
3.Is critically ill & has a diagnosis likely to result in death.
4.TB meningitis or other forms of extrapulmonary TB
5.History of allergy or hypersensitivity to any of the trial IMP
6.For HIV infected subjects any of the following:
a.CD4+ count <100 cells/µL;
b.Karnofsky score <60%;
c.Received IV antifungal medication < 90 days ago;
d.WHO Clinical Stage 4 HIV.
7.Resistant to fluoroquinolones.
8.Resistant to pyrazinamide.
9.Participated in other trials with IP within 8 weeks prior to trial start.
10.Subjects with any of the following at screening:
a.Cardiac arrhythmia requiring medication;
b.Prolongation of QT/QTc interval with QTcF >450 ms;
c.History of additional risk factors for Torsade de Pointes:
d.Any clinically significant ECG abnormality.
11.Unstable Diabetes Mellitus which required hospitalization for hyper- or hypo-glycaemia within the past year prior to screening.
12.Previous treatment with PA-824.
13.For DS-TB: Previous treatment for tuberculosis within 3 years prior to screening. For the MDR-TB: Previous treatment for MDR-TB.
14.Any diseases in which the use of the std TB drugs is contra-indicated.
15.Use of any drug within 30 days prior to randomisation known to prolong QTc interval.
16.Use of systemic glucocorticoids <1 year of screening.
17.Subjects recently started or needing to start ART within 1 month after randomization.
18.Subjects with the following toxicities at screening as defined by DMID adult toxicity table:
a.creatinine >/= grade 2
b.CrCl level < 30 mLs/min
c.haemoglobin grade 4;
d.platelets >/= grade 3
e.serum potassium < the lower limit of normal
f.AST >/= grade 3
g.ALT >/= grade 3
h.ALP grade 4
i.total bilirubin:
o> 2.0 x ULN, when other liver functions are in the normal range
o>1.50 x ULN when accompanied by any increase in other liver function tests
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of bacteriologic failure or relapse or clinical failure at 12 months from the start of therapy
- Secondary Outcome Measures
Name Time Method Safety and Tolerability;Mycobacterial Characterization ;Pharmacokinetics (PK) and Pharmacokinetics-Pharmacodynamics (PK-PD):;Mycobacterial Characterization ;Pharmacokinetics (PK) and Pharmacokinetics-Pharmacodynamics (PK-PD):;Efficacy