Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment… (NCT05555303) | Clinical Trial Compass
UnknownPhase 2
Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment Week of Multidrug-resistant Tuberculosis
Rwanda20 participantsStarted 2023-03-01
Plain-language summary
Acquired drug-resistance is a major challenge for tuberculosis (TB) care programs. The 2020 WHO guidelines recommends replacing second-line injectables by bedaquiline in rifampicin-resistant TB (RR-TB) treatment regimens. However, recent reports show too high rates of acquired bedaquiline resistance. This may be explained by the delayed onset of action of bedaquiline. The investigators will study whether high-dose amikacin (a second-line injectable), administered during the first week of RR-TB treatment, is safe in 20 patients treated for RR-TB in Rwanda. If safe, further studies will assess whether adding amikacin in the first treatment week protect against acquired bedaquiline resistance. This study is embedded in an ongoing "Master study" of the ShORRT (short oral RR-TB) treatment regimen in Rwanda, a before/after study, with a retrospective cohort (before; the previously recommended second-line injectable-containing RR-TB regimen) and a prospective cohort (after: the newly recommended ShORRT regimen).
Who can participate
Age range
19 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
grade 3-4 AE likely or definitively related to amikacin