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Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis

ConditionDrug Susceptible 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 determine if nicotinamide in combination with bedaquiline, pretomanid, and linezolid, is safe and effective in treating drug-susceptible pulmonary tuberculosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-65 years at consent

Body weight 40-100 kg at screening

Written informed consent obtained

Newly diagnosed pulmonary TB, rifampicin- and isoniazid-sensitive

Disqualifiers

Prior TB within 3 years, >1 prior episode, or anti-TB treatment within 60 days

Extrapulmonary TB (except non-significant pleural/lymph node disease)

Clinically significant comorbidities or substance abuse impacting safety/compliance

Pregnant or breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bedaquiline, pretomanid, linezolid

    Drug

    Group 1 (Approximately 55 participants), Combination of NAM 1500 mg twice daily (BID) with bedaquiline (200 mg once daily \[QD\]), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days

  • Bedaquiline, pretomanid, linezolid

    Drug

    Group 2 (Approximately 55 participants): Combination of NAM 2500 mg BID with bedaquiline (200 mg QD), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days

  • Bedaquiline, pretomanid, linezolid

    Drug

    Group 3 (active control; approximately 55 participants): Combination of bedaquiline (200 mg QD), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days

  • Nicotinamide (NAM)

    Dietary supplement

    Group 1 (Approximately 55 participants), Combination of NAM 2500 mg twice daily (BID) with bedaquiline (200 mg once daily \[QD\]), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days

Treatment groups

165 Participants
are divided into 3 treatment groups
Group A: BPAL/NAM1500Experimental treatment 2 interventions
Group B: BPAL/NAM2500Experimental treatment 2 interventions
Group C: BPALActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Bactericidal Activity

Proportion of participants with sputum culture conversion SCC to negative for Mtb in MGIT liquid culture by Week 8 (Day 56, End of Treatment \[EOTx\]), defined as two consecutive Mtb-negative culture results, collected at least 1 day apart (i.e., not collected on the same day), occurring by Week 9 (Day 64) with no subsequent Mtb-positive cultures through Week 9 (Day 64)

Time frame
From randomization through Day 64 (EOT)
2

Safety: SAEs

Proportion of participants with this event

Time frame
From randomization through Day 64 (EOT)
3

Safety: TEAEs

Proportion of participants with this event

Time frame
From randomization through Day 64 (EOT)
4

Safety: AESIs

Proportion of participants with this event

Time frame
From randomization through Day 64 (EOT)

Secondary outcomes

1

Bactericidal Activity

Time to Sputum culture conversion to negative of Mtb in MGIT sputum culture.

Time frame
Randomization through Day 64 (EOT)
2

Bactericidal activity

Proportion of participants with Mtb-negative MGIT sputum culture(s) at Week 4 (Day 29) and Week 8 (Day 56, EOTx), where confirmation of negative sputum culture at subsequent study timepoint is not required.

Time frame
Randomization through Day 56 (EOTx)
3

Evaluate the PK of NAM when administered with BPaL in Group 1 and 2

Concentrations of NAM and its primary metabolite by measuring specific PK parameters at Day 1 and Day 14 (see protocol).

Time frame
Day 1 and Day 14

Other outcomes

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
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