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Pulmonary TuberculosisPhase 2NCT05807399

PanACEA - STEP2C -01

A Phase 2 study testing BTZ-043, Rifampicin and Isoniazid in people with Pulmonary Tuberculosis and Other Specified Pulmonary Tuberculosis, run by Michael Hoelscher at 10 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a phase 2B/C, open label platform study that will compare the efficacy, safety of experimental regimens with a standard control regimen in participants with newly diagnosed, drug sensitive pulmonary tuberculosis. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
BTZ-043, Rifampicin and Isoniazid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
390 participants
Where
10 sitesin 6 countries
Study dates
14 Apr 2023to 30 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 (in light clothing and with no shoes) 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. Participants who had a previous history of TB may be enrolled in this trial, if they:
  • had a good treatment response in the opinion of the investigator; i.e. TB symptoms improved sufficiently or resolved suggesting a cure of the past episode; AND
  • no persistent microbiological positivity is seen (in case microbiological results are available); AND - their treatment course was completed AND
Show all 17Show fewer
  • the last dose of treatment was more than 3 months ago.
  • A chest X-ray (no older than 2 weeks) which shows abnormalities that, in the opinion of the Investigator, are consistent with TB.
  • Sputum positive on microscopy from concentrated sputum for acid-fast bacilli (at least 1+ on the IUATLD/WHO scale) AND/OR positive GeneXpert MTB/RIF Ultra® semi-quantitative result "medium" or "high" on at least one sputum sample.
  • The participant understands the interaction between the study drugs and certain foods and is willing to forgo the consumption of those foods for the period of study medication.
  • The participant is not of child-bearing potential or is willing to use effective methods of contraception when engaging in heterosexual intercourse, as defined below:
  • Non-childbearing potential:
  • 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 and confirmed by a FSH test.
  • 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.
  • Effective contraception methods: i. Female participants: Two methods, including methods that the participant'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 experimental treatment. For stage 3, female participants of child-bearing potential must have used contraception if any sexual intercourse has occurred after last menses or within the last 3 weeks (whichever is later) before participation, and agree to use non-user dependent contraception: depo-provera injection* or an intrauterine device additional to one barrier method.
  • Including a back-up method of contraception for at least 7 days to prevent unintended pregnancy if injection has been administered within the first 5 days of their menstrual cycle. Otherwise, a back-up barrier method of contraception is required for one month to prevent unintended pregnancy.
  • Male participants: Two methods, including methods that the participant's female sexual partner(s) use. At least one must be a barrier method. Effective contraception must be ensured for at least 12 weeks after the last dose of experimental treatment.

Who cannot join

  • <!-- -->
  • Circumstances that raise doubt about free, unconstrained consent to study participation (e.g., person in detention or person with mental disability)
  • Poor general condition where delay in treatment cannot be tolerated or death within four months is likely.
  • Circumstances (in the opinion of the investigator) that raise doubt about ability to complete the follow-up during the study period.
  • The participant is pregnant or breast-feeding or planning to become pregnant in the study period.
  • The participant is infected with HIV with a CD4 count <220 cells/mm3. If >220 cells/mm3, participants will be included only if any of the following is applicable:
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  • The participant 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 mentioned in section on ARVs or
  • The participant is ARV experienced (has been on ARV´s a minimum of 5 months), AND: ARV treatment is compliant to, or can be modified as described in the section on Antiretroviral Therapy
  • The participant 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 participant has a history of, or current evidence of clinically relevant cardiovascular metabolic, gastrointestinal, neurological, hepato-biliary, renal, 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 b. Evidence of clinically significant extra-pulmonary TB (e.g. miliary TB, TB meningitis, but not limited lymph node involvement) c. Serious lung conditions other than TB, or significant respiratory impairment in the discretion of the investigator d. Uncontrolled diabetes mellitus or diabetes mellitus receiving/requiring treatment with metformin or sulfonylureas e. Cardiovascular disease such as myocardial infarction, heart failure, coronary heart disease, arrhythmia, tachyarrhythmia, or pulmonary hypertension f. Uncontrolled arterial hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure of ≥95 mmHg on two occasions during screening. An attempt at antihypertensive treatment during the screening period is permitted).
  • Long QT syndrome or family history of long QT syndrome or family history of sudden death of unknown or cardiac-related cause h. Alcohol, regular opiate, or other drug abuse that is sufficient to significantly compromise the safety or cooperation of the participant, that includes substances prohibited by the protocol or has led to significant organ damage at the discretion of the investigator; AND/OR any abuse of methamphetamine.
  • History of optic neuropathy j. Vitiligo
  • 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), b. Serum alkaline phosphatase or y-glutamyl transferase > 2.5x the ULN, c. Serum total bilirubin level >1.5x the ULN d. Estimated creatinine clearance -eCrCl (using the CKD-EPI 2021 creatinine formula):
  • Stage 1: Lower than 30 ml/min)
  • Stage 2: Lower than 30ml/min or lower than 60 ml/min in participants living with HIV
  • Stage 3: Lower than 80ml/min e. Proteins in urine dipstick >=2+ f. Haemoglobin level <7.0 g/dl g. Platelet count <50,000/mm3, h. Serum potassium below 3 mmol/l, persisting after correction.
  • ECG findings in the screening ECG: (one or more):
  • QTcF of >450 milliseconds
  • Atrioventricular (AV) block with PR interval > 200 milliseconds
  • 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 2 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. Restricted medication includes the following drug classes, with relevant timing of intake, and possible exceptions. Exceptions may be permissible after discussion with the sponsor medical expert.

Trial locations and contacts

10 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Norbert Heinrich, PD Dr. contact

+49894400 ext. 58905

Norbert.Heinrich@med.uni-muenchen.de

Ivan Noreña, MSc. MD contact

+49894400 ext. 58905

Ivan.Norena@med.uni-muenchen.de

10 sites in 6 countries

South Africa3 sites, 3 recruiting

  • TASK Applied Sciences Clinical Research Centre

    Cape Town, 7500

    Fairoez Ryklief, Dr, +27 (021) 100-3606, dr.fairoez@task.org.za

    Recruiting

  • University of Cape Town Lung Institute

    Cape Town, 7700

    Rodney Dawson, Dr., 27214066864, rodney.dawson@uct.ac.za

    Not yet recruiting

  • Isango Lethemba TB Research Unit. Clinical HIV Research Unit (CHRU), Wits Health Consortium.

    Port Elizabeth, Eastern Cape, 6003

    Kinita Naidoo, Dr., 27112768806, kinaidoo@witshealth.co.za

    Not yet recruiting

Other trials in South Africa

Tanzania3 sites, 3 recruiting

  • Ifakara Health Institute (IHI)

    Bagamoyo

    Beno Huglin, Dr, +255785471937, bmbeya@ihi.or.tz

    Recruiting

  • National Institute for Medical Research (NIMR-MMRC)

    Mbeya, Mbeya

    Lilian Tina Minja, Dr, +255252503364, tminja@nimr-mmrc.org

    Recruiting

  • Kilimanjaro Clinical Research Institute (KCRI)

    Moshi

    James Samwel Ngocho, Dr, +255 765143142, J.ngocho@kcri.ac.tz

    Recruiting

Other trials in Tanzania

Gabon1 site

  • Centre de Recherches Médicales de Lambaréné (CERMEL)

    Lambaréné

    Completed

Other trials in Gabon

Malawi1 site, 1 recruiting

  • Kamuzu College of Health Sciences (formerly College of Medicine)

    Blantyre

    Marriott Nliwasa, Dr

    +265 888 681 948, mnliwasa@medcol.mw

    Recruiting

Other trials in Malawi

Mozambique1 site, 1 recruiting

  • Instituto Nacional de Saúde (INS)

    Maputo

    Celso Khosa, Dr, +258 829836050, celso.khosa@ins.gov.mz

    Recruiting

Other trials in Mozambique

Uganda1 site, 1 recruiting

  • Makerere University Lung Institute Limited

    Kampala

    Bruce Kirenga, Dr, +256 414 699 134, brucekirenga@yahoo.co.uk

    Recruiting

Other trials in Uganda

About this study

Official title: A Multiple-arm, Multiple-stage (MAMS), Phase 2B/C, Open-label, Randomized, Controlled Platform Trial to Evaluate Experimental Arms Including Optimised Use of Existing and Introduction of Novel Anti-tuberculosis Drugs, in Adults With Newly Diagnosed, Drug-sensitive, Smear-positive Pulmonary Tuberculosis

This is a phase 2B/C, open label platform study that will compare the efficacy, safety of experimental regimens with a standard control regimen in participants with newly diagnosed, drug sensitive pulmonary tuberculosis.

In stage 1, participants will be randomly allocated to the control or one of the 2 rifampicin-containing experimental regimens in the ratio 1:1:1.

Read more

In stage 2, the experimental arm 4 containing BTZ-043 will be added. The allocation ratio will be changed to co-enrol the remaining participants in arms 1- 3 simultaneously with arm 4 in a ratio of 1:1:1:2. When arms 1-2 are fully enrolled and arm 4 is not, further participants will be randomized 1:1 to control and experimental arm 4. Not all countries will participate in stage 2.

In stage 3, participants will be allocated in parallel to control arm treatment (now designated arm 7) or the experimental arms 5 and 6, favouring arm 5, 2:1:1 over arms 6 and control. This stage will start after completion of recruitment in the stages 1 and 2. Enrolment of participants into arm 5 will proceed following review of data from the ENABLE/UNITE-03 (NCT06748937), non-clinical safety data and after endorsement by the DSMB. Thus, arm 5 recruitment might start after arms 6 and 7, which may require an increase in the control arm sample size to ensure controls are recruited concomitantly.

Read the detailed description

This open label, phase 2B/C , randomized, controlled platform trial, will evaluate experimental arms including regimens with optimized doses of rifampicin, pyrazinamide, and moxifloxacin; a regimen with BTZ-043 combined first-line anti-TB drugs; a regimen with alpibectir-boosted ethionamide replacing isoniazid in combination with first-line anti-TB durgs, and a bedaquiline sparing regimen containing new anti-TB drugs (ganfeborole, BTZ-043 and delpazolid) in adults with newly diagnosed, drug sensitive, smear-positive pulmonary tuberculosis

A total of up to 390 (270 for stage 1 and 2, and 120 for stage 3, respectively) adult (≥ 18 years of age) participants will be enrolled.

In case of a high number of dropouts or non-evaluable participants, it may be necessary to recruit more participants into the study.

Also, if the stage 2 starts later than stage 1, it may be necessary to increase the number of control arm participants to achieve a 1:1 ratio of concomitantly recruited control and arm 4 participants until the recruitment for arm 4 is completed (see sample size considerations).

Stage 3 will start after stages 1 and 2 complete recruitment.

Being tested
BTZ-043, Rifampicin, Isoniazid, Pyrazinamide, Moxifloxacin
Keywords
Tuberculosis, Pulmonary, Tuberculosis, Antitubercular Agents, Safety, Tolerability, Pharmacokinetics (PK), Moxifloxacin, BTZ-043, Rifampicin
Medical subject headings
Tuberculosis, Pulmonary, Tuberculosis

What participants receive

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

  • BTZ-043Drug

    BTZ-043 1000mg once daily in arms 4 and 6.

  • RifampicinDrug

    Rifampicin will be dosed in a fixed high-dose (2100 mg for arms 1 and 2) or a weight-banded regular dose (10 mg/kg) in arm 3, 5 and 7.

  • IsoniazidDrug

    Isoniazid will be dosed at fixed dose of 300mg in arms 1 and 2, and regular dose of 5 mg/kg in arm 3 and 7.

  • PyrazinamideDrug

    Pyrazinamide will be dosed in a fixed regular dose in arm 1 (1600 mg), a weight banded high dose in arm 2 (2000/2400 mg) or a weight-banded regular dose (25 mg/kg) in arm 3, 5 and 7.

  • MoxifloxacinDrug

    Moxifloxacin will be dosed at 600 mg orally once daily in arms 1-2.

  • Alpibectir (GSK3729098)Drug

    Alpibectir 45 mg OD plus Ethionamide 500 mg OD combined with rifampicin pyrazinamide and ethambutol at standard weight-banded doses in arm 5.

  • Ganfeborole (GSK3036656)Drug

    Ganfeborole 20 mg OD in arm 6

  • Delpazolid (LCB01-0371)Drug

    Delpazolid 1200mg OD in arm 6

  • Pretomanid (Pa)Drug

    Pretomanid 20mg OD in arm 6.

  • Ethambutol (E)Drug

    Ethambutol 20mg/Kg OD in arm 3, 5 and 7

  • EthionamideDrug

    Ethionamide 500mg OD in arm 5.

Study groups in NCT05807399
Study groupRoleWhat they receive
Arm 1 (Stage 1)ExperimentalRifampicin 2100mg, isoniazid 300mg, pyrazinamide 1600mg moxifloxacin 600mg; given once daily for 17 weeks (R2100HZM600)
Receives: Drug: Rifampicin; Drug: Isoniazid; Drug: Pyrazinamide; Drug: Moxifloxacin
Arm 2 (Stage 1)ExperimentalRifampicin 2100mg, isoniazid 300mg, pyrazinamide 2000mg/2400mg, moxifloxacin 600mg; given once daily for 12 weeks (R2100HZoptM600)
Receives: Drug: Rifampicin; Drug: Isoniazid; Drug: Pyrazinamide; Drug: Moxifloxacin
Arm 3Active comparatorStage 1: control arm (2HRZE-4RH) Stage 2: continuation of control-arm from STAGE 1 (2HRZE-4RH)
Receives: Drug: Rifampicin; Drug: Isoniazid; Drug: Pyrazinamide; Drug: Ethambutol (E)
Arm 4 (Stage 2)ExperimentalRifampicin, Isoniazid, and Pyrazinamide in weight-banded standard dosages with BTZ-043 1,000mg; given once daily for 17 weeks (RHZT), then rifampicin and isoniazid in weight-banded dosages; given once daily for 9 weeks (RH)
Receives: Drug: BTZ-043; Drug: Rifampicin; Drug: Isoniazid; Drug: Pyrazinamide
Arm 5 (Stage 3)ExperimentalAlpibectir (GSK3729098) 45mg, ethionamide 500mg (A/Eto) with possibility of lower alpibectir and Eto doses based on emerging clinical data, from the ENABLE study [ Clinical Trials gov NCT06748937] and non-clinical data and endorsed by the GSK Global safety board, rifampicin, pyrazinamide and ethambutol at standard doses given once daily for 8 weeks, continued with RIF and INH at standard doses for 18 weeks.
Receives: Drug: Rifampicin; Drug: Pyrazinamide; Drug: Alpibectir (GSK3729098); Drug: Ethambutol (E); Drug: Ethionamide
Arm 6 (Stage 3)ExperimentalPretomanid 200mg, ganfeborole (GSK3036656) 20mg, BTZ-043 1000mg and delpazolid (LCB01-0371) 1200mg; given once daily for 26 weeks
Receives: Drug: BTZ-043; Drug: Ganfeborole (GSK3036656); Drug: Delpazolid (LCB01-0371); Drug: Pretomanid (Pa)
Arm 7 (Stage 3)Active comparatorParallel control arm (2HRZE-4RH)
Receives: Drug: Rifampicin; Drug: Isoniazid; Drug: Pyrazinamide; Drug: Ethambutol (E)

What is being measured

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

  1. Time to stable culture conversion to negative in liquid media

    The primary efficacy endpoint of arms 1 and 2 will be time to stable culture conversion to negative in liquid media defined as the time from enrolment to the first of two negative weekly sputum cultures without an intervening positive culture in liquid media, in comparison to arm 3.

    The efficacy of BTZ-043 will be evaluated by measuring the change in mycobacterial load over time on treatment as quantified by time to positivity in BD MGIT 960® liquid culture described by non-linear mixed-effects methodology, in comparison to arm 3.

    Measured: Day 01- Week 26

  2. Change in Mycobacterial load (Stage 3)

    The efficacy of the arms 5 and 6 (Stage 3) will be evaluated by measuring the change in mycobacterial load over time on treatment as quantified by time to positivity in BD MGIT 960® liquid culture described by non-linear mixed-effects methodology, in comparison to arm 7 using the TTP0-8 or 12 weeks slope.

    Measured: Baseline until week 12 of treatment.

Secondary outcomes (14)

  1. Relapse - free survival at 12 months after randomization

    To assess treatment efficacy based on proportion of patients with relapse free outcome at 12 months after randomization.

    Sustained cure at 12 months (52 weeks) after randomization without a failure or relapse event is achieved when all the following criteria are met:

    • known to be alive at or after 48 weeks after randomization;
    • having Sustained Culture Negativity at 48 weeks after randomization;
    • not having met criteria for Failure or Relapse event (see below);
    • not in need of TB treatment and having had no substantial treatment modifications or additional treatment for TB outside of the pre-specified treatment strategies.

    Measured: Day 01-364

  2. Frequency of all adverse events (serious and non-serious)

    To assess the frequency, severity, and type of adverse events (AEs), and AE related treatment discontinuations.

    Measured: Day 01-182

  3. Frequency of adverse events of Grade 3 severity (severe) or higher

    Severity of AEs will be classified following the U.S. National Institutes of Health Common Terminology Criteria for Adverse Events 5.0 (CTCAE). The minimum grade is 1 (Mild) and the maximum grade is 5 (Death related to AE). Higher scores mean a worse outcome.

    Measured: Day 01-182

  4. Frequency of adverse events possibly, probably or definitely related to study drug

    To assess the frequency, severity, and type of adverse events (AEs), and AE related treatment discontinuations.

    Measured: Day 01-182

  5. Frequency of treatment discontinuations or interruptions related to adverse events/serious adverse event

    To assess the frequency, severity, and type of adverse events (AEs), and AE related treatment discontinuations.

    Measured: Day 01-182

  6. Changes in ECG intervals of PR, RR, QRS, QT, Fridericia-corrected QT [QTcF]

    • Proportion of participants with QTcF > 500ms in ECGs on treatment
    • Proportion of participants who have a QTcF prolongation of grade 3 or higher

    Measured: Day 01-182

  7. Area under the plasma concentration curve from dosing to the end of the dosing interval (AUC 0-24) predicted from limited pharmacokinetic sampling.

    For RIF, PZA, MXF, and IHN (arms 1-3), and BTZ-043, RIF, INH and PZA (arm 4) in all participants with limited pharmacokinetic sampling strategy being done on WK 02 (Day 14 ± 2 Days).

    Measured: Day 14

  8. The observed maximum concentration (Cmax)

    For RIF, PZA, MXF, and IHN (arms 1-3), and BTZ-043, RIF, INH and PZA (arm 4) in all participants with limited pharmacokinetic sampling strategy being done on WK 02 (Day 14 ± 2 Days).

    Measured: Day 14

  9. Time to reach Cmax (Tmax)

    For RIF, PZA, MXF, and IHN (arms 1-3), and BTZ-043, RIF, INH and PZA (arm 4) in all participants with limited pharmacokinetic sampling strategy being done on WK 02 (Day 14 ± 2 Days).

    Measured: Day 14

  10. Minimum observed plasma concentration 24 hours following the last dose (Cmin)

    For RIF, PZA, MXF, and IHN (arms 1-3), and BTZ-043, RIF, INH and PZA (arm 4) in all participants with limited pharmacokinetic sampling strategy being done on WK 02 (Day 14 ± 2 Days).

    Measured: Day 14.

  11. DTG and TFD concentration

    concentrations will be compared at screening and at week 2. More time points may be determined if leftover samples are available. Timing of last DTG and TFD dose intake will be recorded.

    Measured: Day 01-15

  12. Identification of M. tuberculosis complex and Rifampicin (RIF) resistance by PCR (GeneXpert Ultra MTB/RIF®/GeneXpert XDR/HAIN MTBDRplus or similar)

    Cultures grown from the screening period, and the last sputum sample with mycobacteriological growth will be assessed. This test is qualitative, therefore the result will be: Detected, not detected or indeterminate.

    Measured: Day 01-182

  13. Identification of M. tuberculosis complex and Isoniazid (INH) resistance by PCR (GeneXpert Ultra MTB/RIF®/GeneXpert XDR/HAIN MTBDRplus or similar)

    Cultures grown from the screening period, and the last sputum sample with mycobacteriological growth will be assessed. This test is qualitative, therefore the result will be: Detected, not detected or indeterminate.

    Measured: Day 01-182

  14. Minimum inhibitory concentrations (MIC) of study drugs the patient was receiving

    Cultures grown from the screening period, and the last sputum sample with mycobacteriological growth will be assessed.

    Measured: Day 01-182

Timeline

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

  1. First posted11 Apr 2023
  2. Study start14 Apr 2023
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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
Model description
The study will compare the efficacy, safety of 5 experimental regimens with a standard control regimen in participants with newly diagnosed, drug sensitive pulmonary tuberculosis. In stage 1, participants will be randomly allocated to the control or one of the 2 rifampicin-containing experimental regimens in the ratio 1:1:1. In stage 2, the experimental arm 4 containing BTZ-043 will be added. The allocation ratio will be changed to co-enrol the remaining participants in arms 1- 3 simultaneously with arm 4 with an allocation ratio of 1:1:1:2. When arms 1-2 are fully enrolled and arm 4 is not, further participants will be randomized 1:1 to control and experimental arm 4. Not all countries will participate in stage 2. In stage 3, participants will be allocated in parallel to control arm treatment (now designated arm 7) or the experimental arms 5 and 6, favouring arm 5, 2:1:1 over arms 6 and control. This stage will start after completion of recruitment in the stages 1 and 2.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
390 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05807399
Sponsor's protocol ID
PanACEA - STEP2C -01
Status last verified
Oct 2025
First submitted
14 Feb 2023
Last updated
7 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Currently exploring data sharing via the TB CAPT research data repository.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BTZ-043, Rifampicin and Isoniazid in people with Pulmonary Tuberculosis and Other Specified Pulmonary Tuberculosis, run by Michael Hoelscher at 10 sites in 6 countries.

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 17 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in South Africa, Tanzania, Gabon, Malawi, Mozambique and 1 more country. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Norbert Heinrich, PD Dr. (+49894400 ext. 58905, Norbert.Heinrich@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to stable culture conversion to negative in liquid media (time frame: Day 01- Week 26). The study lists 2 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 NCT05807399.

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 7 Oct 2025.

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