Adding Amikacin to TB Treatment to Prevent Drug Resistance
Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment Week of Multidrug-resistant Tuberculosis (Stake) Amendment to Study Protocol: "All-oral Shorter Treatment Regimen for Multidrug- and Rifampicin-resistant Tuberculosis (MDR/RR-TB): Evaluating Its Effectiveness, Safety and Impact on the Quality of Life of Patients in Rwanda" (ShORRT)
This study is testing if adding a high dose of amikacin to the first week of treatment for people with multidrug-resistant tuberculosis in Rwanda can help prevent the bacteria from becoming resistant to a key medication.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 19 Years to 64 Years |
| Sex | All |
| Sponsor | Rwanda Biomedical Centre Academic / other |
| Locations | 1 site (Kabutare) |
| Trial ID | NCT05555303 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety of adding high-dose amikacin during the first week of treatment for patients with multidrug-resistant tuberculosis (MDR-TB) in Rwanda. The goal is to determine if this approach can help prevent the development of acquired resistance to bedaquiline, a key drug in treating rifampicin-resistant TB. The study involves 20 patients enrolled in a larger ongoing trial, with a focus on assessing the safety of this intervention before further evaluating its effectiveness. The research is part of a broader effort to improve treatment regimens for MDR-TB.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 65 with confirmed rifampicin-resistant tuberculosis who are enrolled in the Master SHORRT study.
Not a fit: Patients with audiometry abnormalities, kidney disease, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of TB treatment and reduce the risk of developing drug resistance.
How similar studies have performed: While this approach is novel, it builds on existing knowledge of TB treatment strategies, and similar studies have shown promise in addressing drug resistance.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kabutare
- Kabutare hospital — Kabutare, Rwanda (Recruiting)
Study contacts
- Principal investigator: Yves Habimana-Mucyo, MSc — Rwanda Biomedical Centre
- Study coordinator: Yves Habimana-Mucyo, MSc
- Email: yves.mucyo@rbc.gov.rw
- Phone: +250733436765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.