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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2026-02-28

Brief Summary

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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).

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Detailed Description

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Conditions

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Tuberculosis, Multidrug-Resistant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amikacin

Group Type OTHER

Amikacin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Enrolled in the Master SHORRT study
* Able and willing to provide written informed consent for the present substudy "Stake"

* 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

* 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

* 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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No