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PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE)

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

NCT04550832•LigaChem Biosciences, Inc.

View on ClinicalTrials.gov

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

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provide written, informed consent prior to all trial-related procedures including HIV testing.
•2. Male or female, aged between 18 and 65 years, inclusive.
•3. Body weight between 40 and 90 kg, inclusive.
•4. 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.
•5. A chest X-ray (no older than 2 weeks) which, in the opinion of the Investigator, is consistent with TB.
•6. 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).
•7. 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).
•8. 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:
•a. 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.

Exclusion Criteria

•1. Circumstances that raise doubt about free, unconstrained consent to study participation (e.g. prisoner or mentally handicapped person)
•2. Poor general condition where delay in treatment cannot be tolerated or death within four months is likely.
•3. Poor social condition which would make it unlikely that the patient would be able to complete follow-up
•4. The patient is pregnant or breast-feeding.
•5. 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.
•* 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.
•6. 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
+33 more criteria

Locations (5)

The Aurum Institute Tembisa Clinical Research Centre

Tembisa, Gauteng, South Africa

Clinical HIV Research Unit (CHRU) University of the Witwatersrand

Johannesburg, South Africa

Ifakara Health Institute

Bagamoyo, Tanzania

National Institute for Medical Research (NIMR-MMRC)

Mbeya, Tanzania

Ki'bongoto Infectious Disease Hospital (KIDH) Kilimanjaro Clinical Research Institute (KCRI)

Moshi, Tanzania

Key Dates

Start Date

October 28, 2021

Primary Completion Date

January 4, 2023

Completion Date

September 11, 2023

Last Updated

September 16, 2025

Enrollment

ACTUAL participants

Conditions

Infections and InfestationsPulmonary Tuberculosis

Interventions

Delpazolid

DRUG

Bedaquiline, Delamanid, Moxifloxacin

DRUG

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NCT06192160

Pulmonary Tuberculosis

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RECRUITINGPHASE3

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NCT04260477

Multidrug-resistant TuberculosisPulmonary Tuberculosis+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE)

Inclusion Criteria

Exclusion Criteria

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