Infections and InfestationsPhase 2DECODENCT04550832

PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE)

A Phase 2 study testing Delpazolid and Bedaquiline, Delamanid, Moxifloxacin in people with Infections and Infestations and Pulmonary Tuberculosis, run by LigaChem Biosciences, Inc. at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial is to describe the safety, tolerability and exposure-toxicity relationship of Depazolid given over 16 weeks, in combination with standard-dose Bedaquiline, Delamanid and Moxifloxacin, compared to standard-dose Bedaquiline, Delamanid and Moxifloxacin alone Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Infections and Infestations, Pulmonary Tuberculosis
What is being tested?: Delpazolid and Bedaquiline, Delamanid, Moxifloxacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 5 sitesin 2 countries
Study dates: 28 Oct 2021to 11 Sep 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provide written, informed consent prior to all trial-related procedures including HIV testing.
Male or female, aged between 18 and 65 years, inclusive.
Body weight between 40 and 90 kg, inclusive.
Newly diagnosed, previously untreated, drug susceptible pulmonary TB: presence of MTB complex and rapid molecular tests result confirming susceptibility to RIF and INH such as GeneXpert and/or HAIN MTBDR plus.
A chest X-ray (no older than 2 weeks) which, in the opinion of the Investigator, is consistent with TB.
Sputum positive on microscopy from concentrated sputum for acid-fast bacilli on at least one sputum sample (at least 1+ on the IUATLD/WHO scale).

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The participant is willing to forgo consumption of foods high in tyramine for the period of taking study medication (See Appendix, section 20.2, page 92).
The participant is either unable to conceive/father children AND/OR his/her partner is unable to conceive/father children AND/OR they will consent to be using effective methods of contraception when engaging in heterosexual intercourse, as defined below:
Non-childbearing potential: i. Female participant/sexual partner of male participant: Bilateral oophorectomy, and/or hysterectomy or bilateral tubal ligation more than 12 months ago and/or has been postmenopausal with a history of no menses for at least 12 consecutive months ii. Male participant/sexual partner of female participant: Vasectomised or has had a bilateral orchidectomy minimally three months prior to screening iii. Male participants having a pregnant female partner or a male sexual partner: At least one barrier method has to be used in this case. b. Effective contraception methods: i. Female participants: Two methods, including methods that the patient's sexual partner(s) use. At least one must be a barrier method. Contraception must be practised for at least until 12 weeks after the last dose of DZD. ii. Male participants: Two methods, including methods that the patient's female sexual partner(s) use. At least one must be a barrier method. Effective contraception must be ensured for at least 16 weeks after the last dose of DZD.
Note: hormone-based contraception alone may not be reliable when taking RIF during continuation phase; therefore, hormone-based contraceptives alone cannot be used by female participants/female partners of male participants to prevent pregnancy.

Who cannot join

Circumstances that raise doubt about free, unconstrained consent to study participation (e.g. prisoner or mentally handicapped person)
Poor general condition where delay in treatment cannot be tolerated or death within four months is likely.
Poor social condition which would make it unlikely that the patient would be able to complete follow-up
The patient is pregnant or breast-feeding.
The patient is infected with HIV with a CD4 count <220 cells/mm3. If >220 cells/mm3, patients will be included only if any of the following is applicable:
The patient is antiretroviral (ARV) naïve and able to postpone commencing HIV treatment for 2 months after the trial has started and then restrict regimens to those containing dolutegravir (see section 12.6.2 on ARVs) or The patient is ARV experienced (has been on ARV´s a minimum of 5 months) and able to switch to a dolutegravir-based regimen.

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The patient is treated with nucleosidic reverse transcriptase inhibitors (are permitted as concomitant medication).
The patient is treated with protease inhibitors as part of antiretroviral treatment regimens, which will be stopped at least 3 days before the start of study treatment (WK01, day1) for a patient to be eligible.
The patient is treated with Efavirenz as part of antiretroviral treatment regimens which would have to be stopped 14 days before the start of study treatment (WK00, Day 01) for a patient to be eligible.
The patient has a known intolerance to any of the study drugs or concomitant disorders or conditions for which study drugs or standard TB treatment are contraindicated
The patient has a history of, or current evidence of clinically relevant cardiovascular metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or any other condition that will influence treatment response, study adherence or survival in the judgement of the investigator, especially:
Neuropathy, or significant psychiatric disorder like depression or schizophrenia; especially if treatment for those has ever been required or is anticipated to be required
Clinically significant evidence of extra-pulmonary TB (e.g. miliary TB, TB meningitis, but not limited lymph node involvement)
Serious lung conditions other than TB, or significant respiratory impairment in the discretion of the investigator
Any diabetes mellitus
Cardiovascular disease such as myocardial infarction, heart failure, coronary heart disease, arrhythmia, tachyarrhythmia, or pulmonary hypertension
Arterial hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure of ≥90 mmHg on two occasions during screening).
Long QT syndrome or family history of long QT syndrome or sudden death of unknown or cardiac-related cause
Alcohol or other drug abuse that is sufficient to significantly compromise the safety or cooperation of the patient, that includes substances prohibited by the protocol or has led to significant organ damage at the discretion of the investigator.
Any of the following laboratory findings at screening:
Serum amino aspartate transferase (AST) and/or alanine aminotransferase (ALT) >3x the upper limit of normal (ULN),
Serum alkaline phosphatase or y-glutamyl transferase > 2.5x the ULN,
Serum total bilirubin level >1.5x the ULN
Estimated creatinine clearance (eCrCl; using the Cockroft and Gault formula [57] lower than 30 ml/min
Serum albumin < 2.8 mg/dl
Haemoglobin level <7.0 g/dl
Platelet count <50,000/mm3
Serum potassium below the lower level of normal for the laboratory
Blood glucose at screening of less than 70mg/dL (3.9mmol/L)
ECG findings in the screening ECG: (one or more):
QTcF of >0.450 s
Atrioventricular (AV) block with PR interval > 0.20 s,
QRS complex > 120 milliseconds
Any other changes in the ECG that are clinically relevant as per discretion of the investigator
Restricted medication:
Treatment with any other investigational drug within 1 month prior to enrolment or enrolment into other clinical (intervention) trials during participation.
Previous anti-TB treatment with drugs active against MTB within the last 3 months prior to screening.
Unable or unwilling to abide by the requirements regarding restricted medication or have taken restricted medication as described under section 12.6, page 58. Restricted medication includes the following drug classes:
Anti-TB drugs other than study drugs
Medication that lowers the threshold for epileptic seizures
Medication that prolongs the QTc interval
Drugs that affect monoaminooxidase or serotonin metabolism
CYP 450 inhibitors or inducers, including grapefruit containing foods / beverages and St. John's Wort

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

Tanzania3 sites

Ifakara Health Institute
Bagamoyo
National Institute for Medical Research (NIMR-MMRC)
Mbeya
Ki'bongoto Infectious Disease Hospital (KIDH) Kilimanjaro Clinical Research Institute (KCRI)
Moshi

Other trials in Tanzania

South Africa2 sites

Clinical HIV Research Unit (CHRU) University of the Witwatersrand
Johannesburg, 2092
The Aurum Institute Tembisa Clinical Research Centre
Tembisa, Gauteng, 1632

Other trials in South Africa

About this study

Official title: A Phase IIb, Open Label, Randomized Controlled Dose Ranging Multi-Center Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Exposure-Response Relationship of Different Doses of Delpazolid in Combination With Bedaquiline Delamanid Moxifloxacin in Adult Subjects With Newly Diagnosed, Uncomplicated, Smear-Positive, Drug-sensitive Pulmonary Tuberculosis

Read the detailed description

This will be an open label Phase IIb dose-finding, randomized, controlled study with a duration of 16 weeks of experimental therapy of Delpazolid(DZD) - Bedaquiline/Delamanid/ Moxifloxacin (BDM) in adult patients with newly diagnosed, smear positive, uncomplicated, drug sensitive pulmonary tuberculosis (TB) to evaluate the safety, efficacy, tolerability, pharmacokinetics and exposure/response-relationship of different doses of delpazolid in combination with bedaquiline, delamanid and moxifloxacin.

Participants will be randomized to one of five arms containing BDM standard dose with different doses of DZD.

Conditions: Infections and Infestations, Pulmonary Tuberculosis
Being tested: Delpazolid, Bedaquiline, Delamanid, Moxifloxacin
Keywords: drug-sensitive TB
Medical subject headings: Infections, Tuberculosis, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DelpazolidDrug
Also called LCB01-0371
Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
Bedaquiline, Delamanid, MoxifloxacinDrug
Also called BDM
These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.

Study groups in NCT04550832
Study group	Role	What they receive
Arm1(D0)	Active comparator	Participants receive the following medication for the duration of 16weeks together with food. * Delpazolid : Will not administered * Bedaquiline: will be dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week. * Delamanid: will be dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg. * Moxifloxacin: will be dosed as per the licensed dose: 400 mg orally once daily Receives: Drug: Bedaquiline, Delamanid, Moxifloxacin
Arm2(D400)	Experimental	Participants receive the following medication for the duration of 16weeks together with food. * Delpazolid : Will be dosed 400 mg orally once daily * Bedaquiline: will be dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week. * Delamanid: will be dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg. * Moxifloxacin: will be dosed as per the licensed dose: 400 mg orally once daily Receives: Drug: Delpazolid; Drug: Bedaquiline, Delamanid, Moxifloxacin
Arm3(D800-OD)	Experimental	Participants receive the following medication for the duration of 16weeks together with food. * Delpazolid : Will be dosed 800 mg orally once daily * Bedaquiline: will be dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week. * Delamanid: will be dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg. * Moxifloxacin: will be dosed as per the licensed dose: 400 mg orally once daily Receives: Drug: Delpazolid; Drug: Bedaquiline, Delamanid, Moxifloxacin
Arm4(D1200)	Experimental	Participants receive the following medication for the duration of 16weeks together with food. * Delpazolid : Will be dosed 1200 mg orally once daily * Bedaquiline: will be dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week. * Delamanid: will be dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg. * Moxifloxacin: will be dosed as per the licensed dose: 400 mg orally once daily Receives: Drug: Delpazolid; Drug: Bedaquiline, Delamanid, Moxifloxacin
Arm5(D800-BD)	Experimental	Participants receive the following medication for the duration of 16weeks together with food. * Delpazolid : Will be dosed 800 mg orally twice daily * Bedaquiline: will be dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week. * Delamanid: will be dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg. * Moxifloxacin: will be dosed as per the licensed dose: 400 mg orally once daily Receives: Drug: Delpazolid; Drug: Bedaquiline, Delamanid, Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety Outcome : Proportion of Patients Experiencing Adverse Event
Participants with ≥ 1 TEAE, by severity, related Adverse events: possibly, probably, or definitely related to study drugs
Measured: week0 - week52
Efficacy Outcome: Exposure-response Analysis With TTP (Time to Positive)_AUC0-24
The efficacy of DZD was evaluated by measuring the change in mycobacterial load over time on treatment as quantified by TTP (Time to positive) in BD MGIT960® liquid culture described by non linear mixed effects methodology. A population PK model was developed using NONMEM version 7.4.1. DZD PK is well-described by a two-compartment model with first-order absorption, first-order elimination and a proportional residual error. The final model included allometric scaling based on FFM.
Measured: Week 0 - Week 16
Efficacy Outcome: Exposure-response Analysis With TTP (Time to Positive)_Cmax
The efficacy of DZD was evaluated by measuring the change in mycobacterial load over time on treatment as quantified by TTP (Time to positive) in BD MGIT960® liquid culture described by non linear mixed effects methodology. A population PK model was developed using NONMEM version 7.4.1. DZD PK is well-described by a two-compartment model with first-order absorption, first-order elimination and a proportional residual error. The final model included allometric scaling based on FFM.
Measured: Week 0 - Week 16
Efficacy Outcome: Exposure-response Analysis With TTP (Time to Positive)_Cmin
The efficacy of DZD was evaluated by measuring the change in mycobacterial load over time on treatment as quantified by TTP (Time to positive) in BD MGIT960® liquid culture described by non linear mixed effects methodology. A population PK model was developed using NONMEM version 7.4.1. DZD PK is well-described by a two-compartment model with first-order absorption, first-order elimination and a proportional residual error. The final model included allometric scaling based on FFM.
Measured: Week 0 - Week 16

Secondary outcomes (6)

Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Summary of Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media - Intent to Treat Population Sputum samples were collected for BD MGIT960® Liquid Media culture at all time points during the treatment and follow-up phases, and this table shows culture results, which are reported as: Positive, Negative, Contaminated, Missing.
Note: Contaminated cultures are shown as contaminated for the purpose of the overall result but are counted as missing for calculating summary statistics. The data recorded as 'Positive for MTB Complex with Contamination' are included as 'Positive' for MGIT result. However, the data from mean and median calculations for TTP (Time to positive) due to contamination.
Measured: Week 0 - Week 16
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
The efficacy of DZD was evaluated by measuring the change in mycobacterial load over time on treatment as quantified by time to positivity (TTP) in BD MGIT 960® liquid culture described by nonlinear mixed-effects methodology. Sputum samples were collected for BD MGIT960® Liquid Media culture at all time points during the treatment and follow-up phases, and this table shows TTP results.
Measured: Week 0 - Week 16
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Summary of Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Culture Conversion in Loewenstein-Jensen Solid Media - Intent-to-Treat Population Sputum samples were collected for Loewenstein-Jensen Solid Media culture at at Week 0, Week 8, Week 12, Week 6 during the treatment and follow-up phases, and this table shows culture results, which are reported as: Positive, Negative, Contaminated, Missing.
Measured: Week 0 - Week 16
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Culture conversion was defined as 2 negative cultures without an intervening positive culture. Time was measured as time on treatment until the first negative culture (up to Week 16 Visit).
'Converted by Week x' shows proportion converted by day corresponding to end of each week, e.g., Week 2 = Day 14.
Measured: Week 0 - Week 16
Efficacy Outcome: Time to Culture Conversion
Time to culture conversion was defined as 2 negative cultures without an intervening positive culture. Time was measured as time on treatment until the first negative culture (up to Week 16 Visit).
Measured: Week 0 - Week 16
Efficacy Outcome : Relapse or Reinfection
A participant was positive for relapse or reinfection if they converted to culture negative by Week 8 and had 2 consecutive positive cultures after Week 16 of randomization, without an intervening negative.
Measured: Week0 - Week52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 202111 Sep 2023

First posted16 Sep 2020
Study start28 Oct 2021
Primary completion4 Jan 2023
Study completion11 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Infections and InfestationsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04550832
Sponsor's protocol ID: LCB01-0371-20-2-02
Other IDs: PanACEA-DECODE-01
Acronym: DECODE
Status last verified: Aug 2025
First submitted: 1 Sep 2020
Last updated: 16 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Deidentified individual patient data, that underlie the results in published article(s) based on data from the trial which including text, tables, figures will be presented to various stakeholders. This reported will be presented to various stakeholder during various forums or meetings. First esults will be disclosed to participants, staff and our site Community Advisory Board. Thereafter we would invite several stakeholders from the community or visit their establishments to review study results. Simultaneously, the studying findings report will be sent to the various regulatory authorities, including the National Department of Health (NDoH). With NDoH and its divisions we will establish needs for further engagement and suggestions for policy or programmatic changes.

Publications

Minja LT, van der Feltz I, Manyama C, Mpagama S, Mhimbira F, Norena I, Sebe M, Rassool M, Wallis RS, Ntinginya N, Liyoyo A, Mbeya B, Wagnerberger L, Zumba T, Peter DD, Makkan H, Sloan DJ, Brake LT, Schildkraut JA, Aarnoutse R, McHugh TD, Wildner L, Boeree MJ, Geiter L, Cho YL, Aldana BH, Phillips PPJ, Hoelscher M, Svensson EM, Heinrich N; PanACEA consortium. Delpazolid in combination with bedaquiline, delamanid, and moxifloxacin for pulmonary tuberculosis (PanACEA-DECODE-01): a prospective, randomised, open-label, phase 2b, dose-finding trial. Lancet Infect Dis. 2025 Nov;25(11):1219-1229. doi: 10.1016/S1473-3099(25)00289-0. Epub 2025 Jul 8.
PubMed 40645198
Dierig A, Hoelscher M, Schultz S, Hoffmann L, Jarchow-MacDonald A, Svensson EM, Te Brake L, Aarnoutse R, Boeree M, McHugh TD, Wildner LM, Gong X, Phillips P, Minja LT, Ntinginya N, Mpagama S, Liyoyo A, Wallis RS, Sebe M, Mhimbira FA, Mbeya B, Rassool M, Geiter L, Cho YL, Heinrich N. A phase IIb, open-label, randomized controlled dose ranging multi-centre trial to evaluate the safety, tolerability, pharmacokinetics and exposure-response relationship of different doses of delpazolid in combination with bedaquiline delamanid moxifloxacin in adult subjects with newly diagnosed, uncomplicated, smear-positive, drug-sensitive pulmonary tuberculosis. Trials. 2023 Jun 6;24(1):382. doi: 10.1186/s13063-023-07354-5.
PubMed 37280643

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb, Open Label, Randomized Controlled Dose Ranging Multi-Center Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Exposure-Response Relationship of Different Doses of Delpazolid in Combination With Bedaquiline Delamanid Moxifloxacin in Adult Subjects With Newly Diagnosed, Uncomplicated, Smear-Positive, Drug-sensitive Pulmonary Tuberculosis
ClinicalTrials.gov ID: NCT04550832
Acronym / sponsor ID: DECODE / LCB01-0371-20-2-02
Conditions: Infections and Infestations, Pulmonary Tuberculosis
Keywords: drug-sensitive TB
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: LigaChem Biosciences, Inc.Industry (pharma, biotech, devices)
Collaborators: Ludwig-Maximilians - University of Munich, Radboud University Medical Center, University of California, San Francisco
Study start: 28 Oct 2021 (actual)
Primary completion: 4 Jan 2023 (actual)
Study completion: 11 Sep 2023 (actual)
First posted: 16 Sep 2020 (actual)
Results: Posted 28 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Participants will be randomized to one of five arms containing BDM standard dose with different doses of DZD.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Arm1(D0)	Active comparator	Drug: Bedaquiline, Delamanid, MoxifloxacinParticipants receive the following medication for the duration of 16weeks together with food. * Delpazolid : Will not administered * Bedaquiline: will be dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week. * Delamanid: will be dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg. * Moxifloxacin: will be dosed as per the licensed dose: 400 mg orally once daily
Arm2(D400)	Experimental	Drug: Delpazolid, Drug: Bedaquiline, Delamanid, MoxifloxacinParticipants receive the following medication for the duration of 16weeks together with food. * Delpazolid : Will be dosed 400 mg orally once daily * Bedaquiline: will be dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week. * Delamanid: will be dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg. * Moxifloxacin: will be dosed as per the licensed dose: 400 mg orally once daily
Arm3(D800-OD)	Experimental	Drug: Delpazolid, Drug: Bedaquiline, Delamanid, MoxifloxacinParticipants receive the following medication for the duration of 16weeks together with food. * Delpazolid : Will be dosed 800 mg orally once daily * Bedaquiline: will be dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week. * Delamanid: will be dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg. * Moxifloxacin: will be dosed as per the licensed dose: 400 mg orally once daily
Arm4(D1200)	Experimental	Drug: Delpazolid, Drug: Bedaquiline, Delamanid, MoxifloxacinParticipants receive the following medication for the duration of 16weeks together with food. * Delpazolid : Will be dosed 1200 mg orally once daily * Bedaquiline: will be dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week. * Delamanid: will be dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg. * Moxifloxacin: will be dosed as per the licensed dose: 400 mg orally once daily
Arm5(D800-BD)	Experimental	Drug: Delpazolid, Drug: Bedaquiline, Delamanid, MoxifloxacinParticipants receive the following medication for the duration of 16weeks together with food. * Delpazolid : Will be dosed 800 mg orally twice daily * Bedaquiline: will be dosed as per the licensed dose: 400 mg orally once daily for the first 14 days, then 200 mg three times a week. * Delamanid: will be dosed as per the licensed dose: 200 mg orally twice daily doses of 100 mg. * Moxifloxacin: will be dosed as per the licensed dose: 400 mg orally once daily

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Provide written, informed consent prior to all trial-related procedures including HIV testing.
Male or female, aged between 18 and 65 years, inclusive.
Body weight between 40 and 90 kg, inclusive.
Newly diagnosed, previously untreated, drug susceptible pulmonary TB: presence of MTB complex and rapid molecular tests result confirming susceptibility to RIF and INH such as GeneXpert and/or HAIN MTBDR plus.
A chest X-ray (no older than 2 weeks) which, in the opinion of the Investigator, is consistent with TB.

Key exclusion criteria (43 listed)

Circumstances that raise doubt about free, unconstrained consent to study participation (e.g. prisoner or mentally handicapped person)
Poor general condition where delay in treatment cannot be tolerated or death within four months is likely.
Poor social condition which would make it unlikely that the patient would be able to complete follow-up
The patient is pregnant or breast-feeding.
The patient is infected with HIV with a CD4 count <220 cells/mm3. If >220 cells/mm3, patients will be included only if any of the following is applicable:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DelpazolidAlso: LCB01-0371Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.	Drug	Arm2(D400), Arm3(D800-OD), Arm4(D1200), Arm5(D800-BD)
Bedaquiline, Delamanid, MoxifloxacinAlso: BDMThese three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.	Drug	Arm1(D0), Arm2(D400), Arm3(D800-OD), Arm4(D1200), Arm5(D800-BD)

Primary outcome

Safety Outcome : Proportion of Patients Experiencing Adverse Event
Time frame: week0 - week52
Participants with ≥ 1 TEAE, by severity, related Adverse events: possibly, probably, or definitely related to study drugs
Efficacy Outcome: Exposure-response Analysis With TTP (Time to Positive)_AUC0-24
Time frame: Week 0 - Week 16
The efficacy of DZD was evaluated by measuring the change in mycobacterial load over time on treatment as quantified by TTP (Time to positive) in BD MGIT960® liquid culture described by non linear mixed effects methodology. A population PK model was developed using NONMEM version 7.4.1. DZD PK is well-described by a two-compartment model with first-order absorption, first-order elimination and a proportional residual error. The final model included allometric scaling based on FFM.
Efficacy Outcome: Exposure-response Analysis With TTP (Time to Positive)_Cmax
Time frame: Week 0 - Week 16
The efficacy of DZD was evaluated by measuring the change in mycobacterial load over time on treatment as quantified by TTP (Time to positive) in BD MGIT960® liquid culture described by non linear mixed effects methodology. A population PK model was developed using NONMEM version 7.4.1. DZD PK is well-described by a two-compartment model with first-order absorption, first-order elimination and a proportional residual error. The final model included allometric scaling based on FFM.
Efficacy Outcome: Exposure-response Analysis With TTP (Time to Positive)_Cmin
Time frame: Week 0 - Week 16
The efficacy of DZD was evaluated by measuring the change in mycobacterial load over time on treatment as quantified by TTP (Time to positive) in BD MGIT960® liquid culture described by non linear mixed effects methodology. A population PK model was developed using NONMEM version 7.4.1. DZD PK is well-described by a two-compartment model with first-order absorption, first-order elimination and a proportional residual error. The final model included allometric scaling based on FFM.

6 secondary outcomes

Efficacy Outcome: BD MGIT960® Liquid Media Culture Results
Time frame: Week 0 - Week 16
Efficacy Outcome: Changes in Mycobacterial Load Over Time on Treatment as Quantified by Time to Positivity in BD MGIT960® Liquid Media
Time frame: Week 0 - Week 16
Efficacy Outcome: Loewenstein-Jensen Solid Media Culture Results
Time frame: Week 0 - Week 16
Efficacy Outcome: The Proportion Converted by Day Corresponding to End of Each Week
Time frame: Week 0 - Week 16
Efficacy Outcome: Time to Culture Conversion
Time frame: Week 0 - Week 16
Efficacy Outcome : Relapse or Reinfection
Time frame: Week0 - Week52

Results and safety

Results posted to the registry on 28 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm1(D0)	15	15
Arm2(D400)	15	15
Arm3(D800-OD)	15	13
Arm4(D1200)	16	16
Arm5(D800-BD)	15	14

Primary outcome: Safety Outcome : Proportion of Patients Experiencing Adverse Event

Time frame: week0 - week52. Count of participants. Unit: Participants

Measure	Arm1(D0) n = 15	Arm2(D400) n = 15	Arm3(D800-OD) n = 15	Arm4(D1200) n = 16	Arm5(D800-BD) n = 15
TEAE (total)	8	7	7	6	9
Grade 1 (mild)	4	3	0	0	1
Grade 2 (moderate)	4	4	5	5	7
Grade 3 (severe)	0	0	1	1	3
Grade 4 (life-threatening)	0	0	2	0	0
Unrelated	5	3	6	3	6
Unlikely related	0	1	1	1	1
Possibly related	2	1	0	1	4

Population analysed: Safety Population

Primary outcome: Efficacy Outcome: Exposure-response Analysis With TTP (Time to Positive)_AUC0-24

Time frame: Week 0 - Week 16. Median (Full Range). Unit: mg/L*h

Measure	Arm1(D0) n = 15	Arm2(D400) n = 15	Arm3(D800-OD) n = 15	Arm4(D1200) n = 16	Arm5(D800-BD) n = 15
Value	NA (NA to NA)	10.1 (6.86 to 20.4)	28.6 (15.1 to 76.7)	47.0 (11.8 to 94.0)	68.5 (28.8 to 198)

Population analysed: Intent to Treat Population; all randomized participants in the groups to which they were randomly assigned and who have taken at least one dose of study treatment.

Primary outcome: Efficacy Outcome: Exposure-response Analysis With TTP (Time to Positive)_Cmax

Time frame: Week 0 - Week 16. Median (Full Range). Unit: mg/L

Measure	Arm1(D0) n = 15	Arm2(D400) n = 15	Arm3(D800-OD) n = 15	Arm4(D1200) n = 16	Arm5(D800-BD) n = 15
Value	NA (NA to NA)	3.78 (2.92 to 4.45)	7.72 (5.78 to 13.9)	13.7 (9.56 to 19.7)	9.16 (7.56 to 13.4)

Population analysed: Intent to Treat Population; all randomized participants in the groups to which they were randomly assigned and who have taken at least one dose of study treatment.

Primary outcome: Efficacy Outcome: Exposure-response Analysis With TTP (Time to Positive)_Cmin

Time frame: Week 0 - Week 16. Median (Full Range). Unit: mg/L

Measure	Arm1(D0) n = 15	Arm2(D400) n = 15	Arm3(D800-OD) n = 15	Arm4(D1200) n = 16	Arm5(D800-BD) n = 15
Value	NA (NA to NA)	0.00296 (0.000437 to 0.459)	0.00948 (0.000439 to 0.810)	0.00240 (0.000215 to 0.291)	0.00400 (0.000157 to 0.564)

Population analysed: Intent to Treat Population; all randomized participants in the groups to which they were randomly assigned and who have taken at least one dose of study treatment.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Week 0 to Week 52. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm1(D0)	0 of 15 (0%)	8 of 15 (53.3%)	0 of 15
Arm2(D400)	0 of 15 (0%)	7 of 15 (46.7%)	0 of 15
Arm3(D800-OD)	1 of 15 (6.7%)	7 of 15 (46.7%)	0 of 15
Arm4(D1200)	0 of 16 (0%)	6 of 16 (37.5%)	0 of 16
Arm5(D800-BD)	2 of 15 (13.3%)	9 of 15 (60%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 40645198Minja LT, van der Feltz I, Manyama C, Mpagama S, Mhimbira F, Norena I, Sebe M, Rassool M, Wallis RS, Ntinginya N, Liyoyo A, Mbeya B, Wagnerberger L, Zumba T, Peter DD, Makkan H, Sloan DJ, Brake LT, Schildkraut JA, Aarnoutse R, McHugh TD, Wildner L, Boeree MJ, Geiter L, Cho YL, Aldana BH, Phillips PPJ, Hoelscher M, Svensson EM, Heinrich N; PanACEA consortium. Delpazolid in combination with bedaquiline, delamanid, and moxifloxacin for pulmonary tuberculosis (PanACEA-DECODE-01): a prospective, randomised, open-label, phase 2b, dose-finding trial. Lancet Infect Dis. 2025 Nov;25(11):1219-1229. doi: 10.1016/S1473-3099(25)00289-0. Epub 2025 Jul 8.
Derived from this study: PubMed 37280643Dierig A, Hoelscher M, Schultz S, Hoffmann L, Jarchow-MacDonald A, Svensson EM, Te Brake L, Aarnoutse R, Boeree M, McHugh TD, Wildner LM, Gong X, Phillips P, Minja LT, Ntinginya N, Mpagama S, Liyoyo A, Wallis RS, Sebe M, Mhimbira FA, Mbeya B, Rassool M, Geiter L, Cho YL, Heinrich N. A phase IIb, open-label, randomized controlled dose ranging multi-centre trial to evaluate the safety, tolerability, pharmacokinetics and exposure-response relationship of different doses of delpazolid in combination with bedaquiline delamanid moxifloxacin in adult subjects with newly diagnosed, uncomplicated, smear-positive, drug-sensitive pulmonary tuberculosis. Trials. 2023 Jun 6;24(1):382. doi: 10.1186/s13063-023-07354-5.
Individual participant dataSharing planned: Yes. Deidentified individual patient data, that underlie the results in published article(s) based on data from the trial which including text, tables, figures will be presented to various stakeholders. This reported will be presented to various stakeholder during various forums or meetings. First esults will be disclosed to participants, staff and our site Community Advisory Board. Thereafter we would invite several stakeholders from the community or visit their establishments to review study results. Simultaneously, the studying findings report will be sent to the various regulatory authorities, including the National Department of Health (NDoH). With NDoH and its divisions we will establish needs for further engagement and suggestions for policy or programmatic changes.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Tanzania, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Outcome : Proportion of Patients Experiencing Adverse Event (time frame: week0 - week52). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04550832, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.