None listed
Conditions
Interventions
Group 1 Type of group
TBO plus 100 mg of OPC-67683 twice daily
Group name:Group 3 Type of group
TBO plus placebo twice a day
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC),
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Deliver an informed and written consent prior to all procedures related to the study. • That they are men and women between 18 and 64 years of age, inclusive. • A mycobacterial culture of sputum positive for M. tuberculosis or a sputum smear positive for acid resistant bacilli within a period of 60 days prior to the expected date of enrollment. • Patient with tuberculosis caused by clinical strains of the M. tuberculosis complex with confirmed resistance to treatment with isoniazid and rifampicin, or with a rapid positive test for rifampin resistance in a positive sputum smear for acid-resistant bacilli within a period of 60 days prior to the expected date of enrollment. • Findings on-chest radiography consistent with tuberculosis. • Able to produce sputum to perform a mycobacterial culture. • Patients with the potential to procreate should have a negative result in the urine pregnancy test and agree to use a highly effective method of birth control (for example, two of the following precautions: tubal ligation, vaginal diaphragm, device intrauterine, oral contraceptives, contraceptive implant, combined hormonal patch, injectable combined contraceptive or depot medroxyprogesterone acetate) throughout your participation in the study and for the 22 weeks following the last dose (to cover the duration of ovulation) . • Male patients should agree to use an appropriate method of contraception (double barrier) throughout their participation in the study and for 30 weeks following the last dose (to cover the duration of spermatogenesis).
Exclusion criteria
Exclusion criteria: • History of allergies to any nitro-imidazoles or nitro-imidazole derivatives at some time. • Use of medications mentioned in section 4.1 Including: the use of amiodarone at some time during the previous 12 months, use of another antiarrhythmic drug during the previous 30 days and the use of certain other medications, including certain antidepressants, antihistamines and macrolides during Previous 14 days. • Any current serious concomitant disease or renal dysfunction characterized by serum creatinine levels of> 265pmol / L or liver dysfunction characterized by levels of ALT and / or aspartate transferase (AST) three times greater than the upper limit of the laboratory reference range. • Current clinically relevant changes in the ECQ such as a ventricular atrial block (AV), prolongation of the QRS complex by more than .120 milliseconds (both male and female patients), or of either the QTcB Interval or the QTcF above the 430 milliseconds in male patients and 460 milliseconds in female patients. • Clinically relevant current cardiovascular disorder such as heart failure, coronary heart disease, hypertension, arrhythmia, tachycardia or a condition after myocardial infarction. • For HIV-infected patients, a CD4 cell count <350mm3 or being treated with anti-retroviral drugs for HIV infection. • Karnofsky index <60% • Any disease or condition in which the use of nitro-imidazoles or nitro-imidazole derivatives is contraindicated. • Evidence of clinically significant diseases, whether metabolic, gastrointestinal, neurological, psychiatric or endocrine, malignancy or other abnormalities (outside the indication being studied). • Knowledge or certainty of alcohol abuse, that is, abuse sufficient to compromise the safety or cooperation of the patient according to the opinion of the investigator. • A PMi administered one month before Visit 1 (Screening [Days -9 to -3]) • Pregnant women, infants or with plans to conceive or be the father of a child within the time frame described in formulating informed consent. • Recent use of methadone, benzodiazepines, cocaine, amphetamines or methamphetamines, tetrahydrocannabinol, barbiturates, tricyclic and opioid antidepressants as determined by a urine test unless a test is offered that the positive result in the drug test is the result of Authorized medicinal products prescribed by a physician for an Indication that is not related to abuse. • Any disorder that, according to the investigator´s criteria, does not make the subject a good candidate for the study or that could prevent the patient from participating with confidence throughout the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:It is defined that sputum culture conversion occurs at the time a sample of mycobacterial culture of negative sputum is collected, followed by at least one additional sputum sample with negative mycobacterial culture at least 28 days after first sample and which is not followed by any sample with mycobacterial culture of positive sputum at some point during the remaining 84 days of the study. Measure:Proportion of subjects who achieve a negative sputum mycobacterial culture result using the MGIT® system, that is, sputum culture conversion in 56 days. Timepoints:84 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:It is defined that sputum culture conversion occurs at the time a sample of mycobacterial culture of negative sputum is collected, followed by at least one additional sputum sample with negative mycobacterial culture at least 28 days after first sample and which is not followed by any sample with mycobacterial culture of positive sputum at some point during the remaining 84 days of the study. Measure:Change from baseline over time to crop positivity using the MGIT® system. Timepoints:84 days ; Outcome name:It is defined that sputum culture conversion occurs at the time a sample of mycobacterial culture of negative sputum is collected, followed by at least one additional sputum sample with negative mycobacterial culture at least 28 days after first sample and which is not followed by any sample with mycobacterial culture of positive sputum at some point during the remaining 84 days of the study. Measure:AUC from changing the baseline over time to the positivity of the culture in the MGIT® system Timepoints:84 days ; Outcome name:(1 = negative, 0 = positive) using the MGIT® culture system without taking into account the subsequent results of the culture. Measure:Proportion with negative mycobacterial culture in sputum on Day 57 Timepoints:84 days ; Outcome name:It is defined that sputum culture conversion occurs at the time a sample of mycobacterial culture of negative sputum is collected, followed by at least one additional sputum sample with negative mycobacterial culture at least 28 days after first sample and which is not followed by any sample with mycobacterial culture of positive sputum at some point during the remaining 84 days of the study. Measure:Proportion of patients who achieve sputum culture conversion into solid culture medium among all evaluable patients Timepoints:84 days ; Outcome name:(1 = negative. 0 = positive) using a solid culture medium without taking into account subsequ | — |
Countries
China, Egypt, Estonia, Japan, Korea South, Latovia, Peru, Philippines
Contacts
Public ContactEpifanio Sanchez
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed