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Recruiting NCT07525427

Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis

Phase II Interventional Drug Susceptible Pulmonary Tuberculosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bedaquiline, pretomanid and TBD09, Bedaquiline, pretomanid and TBD09, Bedaquiline, pretomanid and TBD09, Bedaquiline, pretomanid and TBD09.
Who it may be relevant to
Registry conditions: Drug Susceptible Pulmonary Tuberculosis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Africa
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2, Open-Label, Multi-Group, Controlled, Randomized Trial of the Safety, Bactericidal Activity, and Pharmacokinetics of TBD09 in Combination With Other Active Agents in Adults With Drug-Sensitive Pulmonary Tuberculosis

Overview

The purpose of this study is to evaluate if TBD09 in combination with other active agents in adults with drug sensitive pulmonary tuberculosis has potential to be safe and effective.

Interventions

  • Drug Bedaquiline, pretomanid and TBD09
    Group 1 (30 participants): The combination of TBD09 (100 mg three times weekly, TIW), bedaquiline (200 mg daily, QD), and pretomanid (200 mg QD), 28 days
  • Drug Bedaquiline, pretomanid and TBD09
    Group 2 (30 participants): The combination of TBD09 (100 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
  • Drug Bedaquiline, pretomanid and TBD09
    Group 3 (30 participants): The combination of TBD09 (300 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
  • Drug Bedaquiline, pretomanid and TBD09
    Group 4 (30 participants): The combination of TBD09 (500 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
  • Drug Bedaquiline, pretomanid and linezolid
    Group 5 (30 participants): The combination of linezolid (600 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days

Primary outcome measures

  • Bactericidal Activity [Time frame: From randomization through Day 28 (EOT)]
  • Safety: SAEs [Time frame: Screening through Day 35 (EOS)]
  • Safety: TEAEs [Time frame: Screening through Day 35 (EOS)]
  • Safety: AESIs [Time frame: Screening through Day 35 (EOS)]
  • Safety: AEs leading to treatment discontinuation [Time frame: Screening through Day 35 (EOS)]
Secondary outcome measures (12)
  • Safety: Hematologic Effect [Time frame: Randomization through Day 35 (EOS)]
  • Safety: Visual Acuity Assessment [Time frame: Randomization through Day 35 (EOS)]
  • Safety: Colour Vision Assessment [Time frame: Randomization through Day 35 (EOS)]
  • Safety: Brief Peripheral Neuropathy Screen (BPNS) score [Time frame: Randomization through Day 35 (EOS)]
  • Safety: Brief Peripheral Neuropathy Screen (BPNS) score [Time frame: Randomization through Day 35 (EOS)]
  • Safety: Brief Peripheral Neuropathy Screen (BPNS) score [Time frame: Randomization through Day 35 (EOS)]
  • Bactericidal activity [Time frame: Day 28 (EOT)]
  • Maximum plasma concentration (Cmax) of TBD09 [Time frame: Day 1 and Day 28]
  • Time to maximum plasma concentration (Tmax) of TBD09 [Time frame: Day 1 and Day 28]
  • Area under the curve from 0 to 24 hours (AUC0-24) of plasma concentration of TBD09 [Time frame: Day 1]
  • Area under the curve from 0 to infinity (AUC0-inf) of plasma concentration of TBD09 [Time frame: Day 28]
  • Area under the curve over the dosing interval on day 28 (AUCtau) of plasma concentration of TBD09 [Time frame: Day 28]

Eligibility criteria

Inclusion criteria

  • Age 18-65 years at consent
  • Body weight 35-100 kg at screening
  • Written informed consent obtained
  • Newly diagnosed rifampicin-sensitive pulmonary TB
  • Molecular confirmation of M. tuberculosis on Xpert MTB/RIF Ultra
  • ≥1+ AFB smear or Xpert Ultra low, medium, or high semi-quantitative result
  • Rifampicin sensitivity on molecular test
  • Chest X-ray consistent with TB (Investigator assessment)
  • Able to spontaneously produce sputum
  • Reproductive requirements met
  • Women of childbearing potential: 2 approved contraceptive methods or abstinence
  • Males: contraception or abstinence through 90 days post-dose

Exclusion criteria

  • Prior anti-TB treatment for the current TB episode within 60 days
  • Prior medication active against Mtb within 3 months
  • Evidence of extra-thoracic TB, per investigator judgement
  • Prior treatment completion for TB within 3 years
  • 2 or more prior episodes of TB
  • Clinically significant history of or current medical condition posing safety risk
  • If HIV positive:
  • Not on ARVs or taking ARVs for <3 months prior to screening OR
  • CD4+ count <200cells/uL at screening OR
  • HIV viral load >200 copies /mL at screening OR
  • AIDS infection or malignancies
  • Meets any of the following laboratory values during screening:
  • AST, ALT, or ALP ≥2.5× ULN
  • Total bilirubin ≥1.2× ULN
  • eGFR <60 mL/min/1.73 m²
  • Hemoglobin <9.0 g/dL (male) or <8.5 g/dL (female)
  • White blood cell count <2,000/mm³
  • Absolute neutrophil count <800/mm³
  • Platelet count ≤100,000/mm³
  • Positive hepatitis B surface antigen
  • Positive hepatitis C antibody
  • HbA1c ≥8.0%
  • Current or recent systemic immunosuppressive therapy, including corticosteroids
  • Significant drug or alcohol abuse affecting compliance or safety
  • Pregnant or breastfeeding, positive pregnancy test, or planning pregnancy shortly after treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Africa · 13 centers
  • Enhancing Care Foundation at Wentworth Hospital — Durban
  • TASK Applied Science - Eden — George
  • Clinical Research and HIV Research Unit (CHRU) @ Helen Joseph Hospital — Johannesburg
  • The Aurum Institute Tembisa — Tembisa
  • CHRU @ Isango Lethemba — Bethelsdorp
  • Madibeng Centre for Research — Brits
  • Setshaba Research Center — Pretoria
  • ONE MRI — Cape Town
  • … and 5 more centers

Identifiers

NCT: NCT07525427 · Gates MRI-TBD09-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗