Tuberculosis
Conditions
Interventions
Placebo
Sponsors
Stellah Mpagama
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A patient is able and willing to provide written informed consent prior to any trial procedure 2. Patient is aged between 18 – 65 years 3. Patient is a newly diagnosed with MDR-TB and not started MDR-TB treatment 4. Patient is eligible for aminoglycoside or bedaquiline based second-line anti-TB drugs 5. Karnofsky score of ? 50 6. Female patient should not be pregnant confirmed by urinary pregnant test (UPT)
Exclusion criteria
Exclusion criteria: 1. Patient has pre-existing profound hearing loss at dB >90 2. Patient has a history of using secondline anti-TB drugs 3. Patient has previous or existing pathology of the external or middle ear which would preclude auditory testing 4. Patient has previous or existing pathology of the inner ear with or without hearing loss (i.e. sudden sensorineural hearing loss, Meniere's disease, autoimmune inner ear disease) 5. Patient has previous or existing pathology of the central nervous system with potential to impact auditory pathways (i.e. major head trauma, meningitis, encephalitis, brain metastasis, vestibular schwannoma) 6. Patient has mental disorder such as schizophrenia, schizoaffective disorder or psychotic disorder 7. Patient is pregnant as indicated by urinary pregnant test (UPT). 8. Patient has comorbid condition such as severe liver or renal diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development of clinical or laboratory-based or both adverse events at any frequency during the first six month of MDR-TB treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics endpoints of second-line anti-TB drugs • Area under the curve (AUC) • Observed Cmax • Volume of distribution • Elimination half life ;Efficacy • Occurrence of ototoxicity (Yes/No) or Hepatoxicity as defined by Common Terminology Criteria for Adverse Event (CTCAE). Hearing loss as defined as 20 dB or more change at any frequency compared to baseline or clinical ototoxicity at the end of 8 months of MDR-TB (conventional) treatment. • Proportion of MDR-TB patients requiring second-line anti-TB regimen modification modifications due to adverse drug events • TB Symptoms profile (Appendix 1) • Time to first negative culture on solid media • Proportion of patients converting to negative sputum culture on solid culture at 4 or 6 or 8 months after treatment initiation • Rate of change of sputum MTB RNA in MBL assay during treatment ;Mycobacteriological identification and characterizations • Identification of MTB complex from direct sputum specimen and susceptibility of first and second-line anti-TB drugs using Taqman Array Card rt-PCR for resistance determining regions in 10 genes • Minimum inhibitory concentration of 12 first and second-line anti-TB drugs using Sensititre MYCOTB plates • Whole Genome Sequence of discordant between TAC and MIC | — |
Countries
United Republic of Tanzania
Contacts
Public ContactAlphonce Liyoyo
Trial Manager
Outcome results
None listed