Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGates Medical Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-65 years at consent
Body weight 35-100 kg at screening
Written informed consent obtained
Newly diagnosed rifampicin-sensitive pulmonary TB
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bedaquiline, pretomanid and TBD09
DrugGroup 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
Bedaquiline, pretomanid and TBD09
DrugGroup 2 (30 participants): The combination of TBD09 (100 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Bedaquiline, pretomanid and TBD09
DrugGroup 3 (30 participants): The combination of TBD09 (300 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Bedaquiline, pretomanid and TBD09
DrugGroup 4 (30 participants): The combination of TBD09 (500 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Bedaquiline, pretomanid and linezolid
DrugGroup 5 (30 participants): The combination of linezolid (600 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Treatment groups
150 Participants
are divided into 5 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention
Group D: Group 4Experimental treatment 1 intervention
Group E: Group 5Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Bactericidal Activity
Average daily change in MGIT sputum culture TTD from baseline to end-of-treatment (EOT)
Time frame
From randomization through Day 28 (EOT)2
Safety: SAEs
Proportion of participants with this event
Time frame
Screening through Day 35 (EOS)3
Safety: TEAEs
Proportion of participants with this event
Time frame
Screening through Day 35 (EOS)4
Safety: AESIs
Proportion of participants with this event
Time frame
Screening through Day 35 (EOS)Secondary outcomes
1
Safety: Hematologic Effect
Proportion of participants who meet each of the following binary classifications of platelets, absolute neutrophil count (ANC), total white blood cell count (WBC), absolute lymphocyte count (ALC), and hemoglobin: 1. Post-baseline result \< lower limit of normal (LLN) among participants with baseline result \> LLN (yes/no) 2. Post-baseline result \< 50% of LLN (yes/no) 3. Post-baseline result ≥50% decrease relative to baseline (yes/no)
Time frame
Randomization through Day 35 (EOS)2
Safety: Visual Acuity Assessment
Proportion of participants with worsening of postbaseline visual acuity score of 2 lines or more in either eye using Snellen-type charts
Time frame
Randomization through Day 35 (EOS)3
Safety: Colour Vision Assessment
Proportion of participants with a new or worsening post-baseline color vision abnormality in either eye (by severity grade) using Ishihara plates
Time frame
Randomization through Day 35 (EOS)4
Safety: Brief Peripheral Neuropathy Screen (BPNS) score
Proportion of participants with a reported new or worsening post-baseline peripheral neuropathy symptom on BPNS in either lower extremity (overall and by severity grade)
Time frame
Randomization through Day 35 (EOS)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Gates Medical Research Institute
Lead sponsor
IQVIA RDS Inc.
Collaborator
Source ClinicalTrials.gov