Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment Week of Multidrug-resistant Tuberculosis

Launched by RWANDA BIOMEDICAL CENTRE · Sep 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to improve treatment for patients with multidrug-resistant tuberculosis (TB). Researchers want to find out if adding a medication called high-dose amikacin during the first week of treatment is safe and can help prevent the development of resistance to another drug called bedaquiline. This is important because some patients are developing resistance to bedaquiline, which makes it harder to treat their TB. The trial will involve 20 patients in Rwanda who are already part of a larger study focused on a new treatment regimen for rifampicin-resistant TB.

To participate in this trial, patients need to be enrolled in the Master SHORRT study and be able to provide consent. However, certain individuals are not eligible, including those with hearing issues, a history of kidney disease, or who are pregnant or breastfeeding. Participants can expect to receive close monitoring during the study to ensure their safety while receiving this new treatment approach. Overall, this trial aims to find better ways to treat TB and reduce the chances of the disease becoming resistant to medications.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Enrolled in the Master SHORRT study
• • Able and willing to provide written informed consent for the present substudy "Stake"
• Exclusion Criteria:
• • Any audiometry abnormality (grade 1 or higher) on baseline audiometry
• • History of kidney disease or baseline creatinine clearance below or equal to 60ml/min
• • Pregnant or breastfeeding women
• • History of previous injectable based tuberculosis treatment (including with streptomycin)
• • \< 18 years and \> 65 years old
• • Patient on NSAID or on diuretics
• • Master ShORRT study
• Inclusion criteria:
• • Is willing and able to give informed consent to be enrolled in the research project and for follow-up
• • Has bacteriologically or molecularly confirmed TB with evidence of resistance to at least rifampicin
• Exclusion criteria:
• • Is unable to take oral medication;
• • Must take any medications contraindicated with the medicines in the MDR/RR-TB regimen;
• • Has a known allergy to any of the drugs in the MDR/RR-TB regimen;
• • Has a QTcF interval of ≥ 500 msec; at baseline that does not correct with medical management.