A Phase 2 interventional study of Amikacin in Tuberculosis, Multidrug-Resistant, sponsored by Rwanda Biomedical Centre. Recruiting at 1 site in Rwanda. Open to participants aged 19 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by Rwanda Biomedical Centre · Phase 2, Interventional, and Treatment
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).
132 studies on the registry are indexed under Tuberculosis, Multidrug-Resistant; 25 are open to participants now.
This study's planned enrollment of 20 is below the median of 194 across 88 interventional studies indexed under Tuberculosis, Multidrug-Resistant.
Browse Tuberculosis, Multidrug-Resistant studies →Rwanda Biomedical Centre is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Master ShORRT study
Inclusion criteria:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Amikacin
In addition to the all-oral RR-TB treatment, add two intramuscular doses each consisting of 30 mg amikacin/kg, a first dose on day 1 and a second dose on day 4, all in the first week of treatment. The amikacin solution will be admixed with a lidocaine solution in the syringe before administration.
grade 3-4 AE likely or definitively related to amikacin
Assess whether less than 14% of patients treated with the amikacin-strengthened regimen will experience a grade 3-4 adverse event likely or definitively related to the use of amikacin
Time frame: After 2 weeks of treatment
turnaround times
Assess the turnaround times to inform the feasibility of doing the tests proposed in this study for the assessment of the response to the use of two doses of amikacin
Time frame: at the end of treatment week 2 (+/- 3 d)
testing coverage
Assess the testing coverage (proportion of patients with a result for each of the tests) to inform the feasibility of doing the tests proposed in this study for the assessment of the response to the use of two doses of amikacin
Time frame: at the end of treatment week 2 (+/- 3 d)
AE likely or definitely related to amikacin
Describe the occurrence of adverse events that are considered as likely or definitely related to the use of amikacin
Time frame: at the end of treatment week 2 (+/- 3 d)
amikacin concentration
Describe the amikacin concentration stratified by values for different treatment response markers : Colony forming units on semi-quantitative culture
Time frame: during the first two treatment weeks
amikacin concentration
Describe the amikacin concentration stratified by values for different treatment response markers : molecular bacterial load
Time frame: during the first two treatment weeks
amikacin concentration
Describe the amikacin concentration stratified by values for different treatment response markers : thin-layer agar semi-quantitative culture
Time frame: during the first two treatment weeks
amikacin concentration
Describe the amikacin concentration stratified by values for different treatment response markers: RNA Synthesis ratio
Time frame: during the first two treatment weeks
amikacin concentration
Describe the amikacin concentration stratified by values for different treatment response markers : time to culture positivity on liquid culture
Time frame: during the first two treatment weeks
post-injection pain
Describe post-injection pain on a 0-10 pain scale (The Wong-Baker FACES pain rating scale) (15)
Time frame: at 0, 15 minutes, 30 minutes and 60 minutes after the injection of amikacin with lidocaine on day 1 and 4, as well as the next morning
all AE, relationship with TB drugs
Describe all AE, by their grade, and their relationship with TB drugs
Time frame: at the end of the ShORRT study, approximately 23 months after the treatment
treatment outcomes
Describe treatment outcomes, using the following effectiveness endpoints: * Month of stable (without reversion) culture conversion * End-of-treatment outcomes (treatment failure, death during treatment, LTFU during treatment, cure, treatment completion) * Treatment outcomes at 12 months post-treatment (end-of treatment outcome corrected for relapse) * Acquired resistance to bedaquiline, fluoroquinolone, amikacin through target deep sequencing on paired baseline and failure sputa
Time frame: at the end of treatment
post-treatment outcomes
Describe post-treatment outcomes, using the following effectiveness endpoints: * Month of stable (without reversion) culture conversion * End-of-treatment outcomes (treatment failure, death during treatment, LTFU during treatment, cure, treatment completion) * Treatment outcomes at 12 months post-treatment (end-of treatment outcome corrected for relapse) * Acquired resistance to bedaquiline, fluoroquinolone, amikacin through target deep sequencing on paired baseline and failure sputa
Time frame: after post-treatment follow-up (part of ShORRT analysis)
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2023 (actual). Primary completion is estimated for Mar 2024, 12 months after the start.
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Studies of the drug tested here: Amikacin
Tuberculosis, Multidrug-Resistant →
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