Tuberculosis, Multidrug-ResistantPhase 4PROSPECTNCT05306223
A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China
A Phase 4 study testing Bedaquiline, Levofloxacin and Linezolid in people with Tuberculosis, Multidrug-Resistant, run by Beijing Chest Hospital at 17 sites in China.
Trial summary
The purpose of this study is to evaluate efficacy and safety of an oral bedaquiline-containing multidrug-resistant tuberculosis (MDR-TB) short-course regimen (SCR) compared to an oral SCR not including bedaquiline at the end of treatment in participants with pulmonary MDR-TB in China. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis, Multidrug-Resistant
- What is being tested?
- Bedaquiline, Levofloxacin and Linezolid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 17 sitesChina
- Study dates
- 10 May 2022to 8 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Has a positive sputum Mycobacterium tuberculosis culture from a test performed at screening
- Has microbiological confirmation of rifampicin resistance by GeneXpert and to isoniazid (INH) via molecular drug-susceptibility testing (DST) showing katG mutation
- Has a chest imaging result compatible with a diagnosis of pulmonary Tuberculosis (TB)
- Agrees to use effective contraception during the 40-week study treatment phase. A female participant must be: of nonchildbearing potential; of childbearing potential and practicing effective methods of contraception during the 40-week study treatment phase
- Is willing to undergo human immunodeficiency virus (HIV) testing
Who cannot join
- Has received prior treatment with bedaquiline
- Has prior exposure to at least 1 second-line drug in the regimen for at least 4 weeks
- Has any grade 3 or 4 laboratory abnormality as confirmed by a clinical expert
- Has a known allergy or intolerance to bedaquiline or other drugs in the regimen
- Is infected with a strain of nontuberculous mycobacteria
- Is HIV-positive
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites, 17 recruiting
- Recruiting
Beijing Chest Hospital
Beijing, 101149
Mengqiu Gao
- Recruiting
The Eighth Medical Center of PLA General Hospital
Beijing
Huiru An
- Recruiting
Changsha Central Hospital
Changsha
Yi Pei
- Recruiting
Public health clinical medical center of Chengdu
Chengdu
Guihui Wu
- Recruiting
Chongqing Public Health Medical Center
Chongqing
Xiaofeng Yan
- Recruiting
The Pulmonary Hospital of Fuzhou in Fujian Province（The tuberculosis control and prevention Hospital of Fuzhou in Fujian Province）
Fuzhou
Xiaohong Chen
- Recruiting
Guiyang Public Health Clinical Center
Guiyang
Zhongfeng Huang
- Recruiting
Anhui Chest Hospital
Hefei
Hua Wang
- Recruiting
Infectious Disease Hospital of Heilongjiang Province
Heilongjiang
Long Jin
- Not yet recruiting
Jiamusi Tumor Hospital
Jiamusi
Xiujie Li
- Not yet recruiting
Jiangxi Chest Hospital
Jiangxi
Yuqing Wu
- Recruiting
Shandong public health clinical center
Shandong
Yu Xiong
- Recruiting
Shanghai Pulmonary Hospital
Shanghai
Wei Sha
- Recruiting
Shenyang Chest Hospital
Shenyang
Lian Shi
- Recruiting
Wuhan Pulmonary Hospital
Wuhan
Juan Du
- Recruiting
Xi'an Chest Hospital
Xi'an
Fei Ren
- Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang
Junwei Cui
About this study
Official title: A Pragmatic Randomized Controlled Trial to Evaluate the Efficacy and Safety of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Patients With Multidrug-resistant Tuberculosis in China
The purpose of this study is to evaluate efficacy and safety of an oral bedaquiline-containing multidrug-resistant tuberculosis (MDR-TB) short-course regimen (SCR) compared to an oral SCR not including bedaquiline at the end of treatment in participants with pulmonary MDR-TB in China.
- Conditions
- Tuberculosis, Multidrug-Resistant
- Being tested
- Bedaquiline, Levofloxacin, Linezolid, Cycloserine, Clofazimine
- Medical subject headings
- Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BedaquilineDrug
Also called SIRTURO
Bedaquiline uncoated tablets will be administered orally.
LevofloxacinDrug
Levofloxacin filmcoated will be administered orally
LinezolidDrug
Linezolid tablets will be administered orally
CycloserineDrug
Cycloserine capsules will be administered orally.
ClofazimineDrug
Clofazimine capsules will be administered orally.
PyrazinamideDrug
Pyrazinamide tablets will be administered orally.
ProtionamideDrug
Protionamide enteric-coated tablets will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Bedaquiline-containing Short-course Regimen (SCR) | Experimental | Participants will receive an oral dose of bedaquiline 400 milligrams (mg) once daily for first 2 weeks followed by bedaquiline 200 mg thrice a week for 22 weeks (with at least 48 hours between doses) in combination with oral doses of levofloxacin (LFX) up to 1000 mg (weight-based), cycloserine (CS) up to 750 mg (weight-based), clofazimine (CFZ) 100 mg daily for 40 weeks and linezolid [LZD] 600 mg daily for at least 24 weeks . If a participant is still sputum culture-positive for Mycobacterium tuberculosis by Week 16, bedaquiline treatment will be extended from Week 24 to Week 40. Receives: Drug: Bedaquiline; Drug: Levofloxacin; Drug: Linezolid; Drug: Cycloserine; Drug: Clofazimine |
| Non-bedaquiline-containing Short-course Regimen (SCR) | Experimental | Participants will receive oral doses of LFX up to 1000 mg (weight-based), CS up to 750 mg (weight-based), CFZ 100 mg, Pyrazinamide (PZA) up to 2000 mg (weight-based), Protionamide (PTO) up to 800 mg (weight-based) daily for first 16 weeks and LZD 600 mg daily for at least 24 weeks. Receives: Drug: Levofloxacin; Drug: Linezolid; Drug: Cycloserine; Drug: Clofazimine; Drug: Pyrazinamide; Drug: Protionamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with a Favorable Treatment Outcome at the End of Treatment
Percentage of participants with a favorable treatment outcome at the end of treatment will be reported. A participant's outcome will be classified as favorable if their last 3 culture results by the end of treatment are negative unless they have previously been classified as unfavorable. These 3 cultures must be taken on separate visits; the latest of which being no more than 8 weeks prior to the end of treatment.
Measured: At the end of treatment (Week 40)
Secondary outcomes (8)
Percentage of Participants with a Favorable Treatment Outcome at 48 Weeks Post the End of Treatment
Percentage of participants with a favorable treatment outcome at 48 weeks post the end of treatment will be reported. A participant's outcome will be classified as favorable if their last 3 culture results by the end of treatment are negative unless they have previously been classified as unfavorable. These 3 cultures must be taken on separate visits; the latest of which being no more than 8 weeks prior to the end of treatment.
Measured: At 48 weeks post the end of treatment (Week 88)
Percentage of Participants Achieving Treatment Success at the end of Treatment
Percentage of participants achieving treatment success at the end of treatment will be reported. Treatment success is achieved if participants completed their prescribed tuberculosis (TB) treatment; or if their last 3 culture results are negative by the end of treatment, these 3 cultures must be taken on separate visits and should be after the initial 6-month treatment period.
Measured: At the end of treatment (Week 40)
Percentage of Participants with a Modified Favorable Treatment Outcome at the end of Treatment and at 48 Weeks Post end of Treatment
Percentage of participants with a modified favorable treatment outcome at the end of treatment and at 48 weeks post end of treatment will be reported. A participant's treatment outcome will be classified as modified favorable if their last 2 culture results by the end of treatment are negative unless they have previously been classified as unfavorable. These 2 cultures must be taken on separate visits; the latest of which being no more than 8 weeks prior to the end of treatment.
Measured: At the end of treatment (Week 40) and at 48 weeks post end of treatment (Week 88)
Percentage of Participants Experiencing All-cause Mortality
Percentage of participants experiencing all-cause mortality will be reported.
Measured: Up to Week 88
Percentage of Participants Experiencing Grade 3 or Greater Treatment-emergent Adverse Events (TEAEs) During Study Treatment and Follow-up
Percentage of participants experiencing grade 3 or greater TEAEs during study treatment and follow-up will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any event that begins or worsens in severity after initiation of study drug through to the end of study. An assessment of severity grade will be made using the following 5 general categorical descriptors based on division of acquired immunodeficiency syndrome (AIDS) grading for AE severity assessment. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death.
Measured: During study treatment and follow-up (From Week 1 up to Week 88)
Percentage of Participants Experiencing TEAEs
Percentage of participants experiencing TEAEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any event that begins or worsens in severity after initiation of study drug through to the end of study.
Measured: From Week 1 up to Week 88
Percentage of Participants with TB Relapses and Re-infections During the Treatment-free Follow-up Phase
Percentage of participants with TB relapses and re-infections during the treatment-free follow-up phase will be reported.
Measured: During the treatment-free follow-up phase (Up to 48 weeks)
Percentage of Participants Whose Isolates Develop Resistance to Bedaquiline and Other Drugs Used in the Regimen
Percentage of participants whose isolates develop resistance to bedaquiline and other drugs used in the regimen will be reported.
Measured: Up to Week 88
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start10 May 2022
- Primary completion8 Aug 2025 (estimated)
- Study completion8 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis, Multidrug-ResistantStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Mengqiu, Beijing Chest Hospital
- Investigators
- Mengqiu Gao, Principal investigator, Beijing Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306223
- Sponsor's protocol ID
- TMC207TBC4006
- Other IDs
- TMC207TBC4006
- Acronym
- PROSPECT
- Status last verified
- Jan 2023
- First submitted
- 23 Mar 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao J, Huang Z, Ren F, Wu Y, Wang H, Wu G, Du J, Yan X, Pei Y, Jin L, Xiong Y, Shi L, Cui J, Chen X, Li X, Sha W, An H, Callewaert K, Lounis N, Bakare N, Jiang Y, Zhang R, Wang L, Gao M, Li L. Evaluation of an oral bedaquiline regimen for treating multidrug-resistant TB in China: a randomized trial. Infection. 2026 Jun;54(3):1265-1277. doi: 10.1007/s15010-026-02734-w. Epub 2026 Apr 2.
PubMed 41925982Gao J, Gao M, Du J, Pang Y, Mao G, Lounis N, Bakare N, Jiang Y, Zhan Y, Liu Y, Li L; Trial Team. A pragmatic randomized controlled trial to evaluate the efficacy and safety of an oral short-course regimen including bedaquiline for the treatment of patients with multidrug-resistant tuberculosis in China: study protocol for PROSPECT. Trials. 2024 Apr 1;25(1):227. doi: 10.1186/s13063-024-07946-9.
PubMed 38561815
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Controlled Trial to Evaluate the Efficacy and Safety of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Patients With Multidrug-resistant Tuberculosis in China
- ClinicalTrials.gov ID
- NCT05306223
- Acronym / sponsor ID
- PROSPECT / TMC207TBC4006
- Conditions
- Tuberculosis, Multidrug-Resistant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Beijing Chest HospitalUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 8 Aug 2025 (estimated)
- Study completion
- 8 Aug 2025 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate efficacy and safety of an oral bedaquiline-containing multidrug-resistant tuberculosis (MDR-TB) short-course regimen (SCR) compared to an oral SCR not including bedaquiline at the end of treatment in participants with pulmonary MDR-TB in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bedaquiline-containing Short-course Regimen (SCR) | Experimental | Drug: Bedaquiline, Drug: Levofloxacin, Drug: Linezolid, Drug: Cycloserine, Drug: ClofazimineParticipants will receive an oral dose of bedaquiline 400 milligrams (mg) once daily for first 2 weeks followed by bedaquiline 200 mg thrice a week for 22 weeks (with at least 48 hours between doses) in combination with oral doses of levofloxacin (LFX) up to 1000 mg (weight-based), cycloserine (CS) up to 750 mg (weight-based), clofazimine (CFZ) 100 mg daily for 40 weeks and linezolid [LZD] 600 mg daily for at least 24 weeks . If a participant is still sputum culture-positive for Mycobacterium tuberculosis by Week 16, bedaquiline treatment will be extended from Week 24 to Week 40. |
| Non-bedaquiline-containing Short-course Regimen (SCR) | Experimental | Drug: Levofloxacin, Drug: Linezolid, Drug: Cycloserine, Drug: Clofazimine, Drug: Pyrazinamide, Drug: ProtionamideParticipants will receive oral doses of LFX up to 1000 mg (weight-based), CS up to 750 mg (weight-based), CFZ 100 mg, Pyrazinamide (PZA) up to 2000 mg (weight-based), Protionamide (PTO) up to 800 mg (weight-based) daily for first 16 weeks and LZD 600 mg daily for at least 24 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has a positive sputum Mycobacterium tuberculosis culture from a test performed at screening
- Has microbiological confirmation of rifampicin resistance by GeneXpert and to isoniazid (INH) via molecular drug-susceptibility testing (DST) showing katG mutation
- Has a chest imaging result compatible with a diagnosis of pulmonary Tuberculosis (TB)
- Agrees to use effective contraception during the 40-week study treatment phase. A female participant must be: of nonchildbearing potential; of childbearing potential and practicing effective methods of contraception during the 40-week study treatment phase
- Is willing to undergo human immunodeficiency virus (HIV) testing
Key exclusion criteria (6 listed)
- Has received prior treatment with bedaquiline
- Has prior exposure to at least 1 second-line drug in the regimen for at least 4 weeks
- Has any grade 3 or 4 laboratory abnormality as confirmed by a clinical expert
- Has a known allergy or intolerance to bedaquiline or other drugs in the regimen
- Is infected with a strain of nontuberculous mycobacteria
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 |
|---|---|---|
| BedaquilineAlso: SIRTUROBedaquiline uncoated tablets will be administered orally. | Drug | Bedaquiline-containing Short-course Regimen (SCR) |
| LevofloxacinLevofloxacin filmcoated will be administered orally | Drug | Bedaquiline-containing Short-course Regimen (SCR), Non-bedaquiline-containing Short-course Regimen (SCR) |
| LinezolidLinezolid tablets will be administered orally | Drug | Bedaquiline-containing Short-course Regimen (SCR), Non-bedaquiline-containing Short-course Regimen (SCR) |
| CycloserineCycloserine capsules will be administered orally. | Drug | Bedaquiline-containing Short-course Regimen (SCR), Non-bedaquiline-containing Short-course Regimen (SCR) |
| ClofazimineClofazimine capsules will be administered orally. | Drug | Bedaquiline-containing Short-course Regimen (SCR), Non-bedaquiline-containing Short-course Regimen (SCR) |
| PyrazinamidePyrazinamide tablets will be administered orally. | Drug | Non-bedaquiline-containing Short-course Regimen (SCR) |
| ProtionamideProtionamide enteric-coated tablets will be administered orally. | Drug | Non-bedaquiline-containing Short-course Regimen (SCR) |
Primary outcome
Percentage of Participants with a Favorable Treatment Outcome at the End of Treatment
Time frame: At the end of treatment (Week 40)
Percentage of participants with a favorable treatment outcome at the end of treatment will be reported. A participant's outcome will be classified as favorable if their last 3 culture results by the end of treatment are negative unless they have previously been classified as unfavorable. These 3 cultures must be taken on separate visits; the latest of which being no more than 8 weeks prior to the end of treatment.
8 secondary outcomes
Percentage of Participants with a Favorable Treatment Outcome at 48 Weeks Post the End of Treatment
Time frame: At 48 weeks post the end of treatment (Week 88)
Percentage of Participants Achieving Treatment Success at the end of Treatment
Time frame: At the end of treatment (Week 40)
Percentage of Participants with a Modified Favorable Treatment Outcome at the end of Treatment and at 48 Weeks Post end of Treatment
Time frame: At the end of treatment (Week 40) and at 48 weeks post end of treatment (Week 88)
Percentage of Participants Experiencing All-cause Mortality
Time frame: Up to Week 88
Percentage of Participants Experiencing Grade 3 or Greater Treatment-emergent Adverse Events (TEAEs) During Study Treatment and Follow-up
Time frame: During study treatment and follow-up (From Week 1 up to Week 88)
Percentage of Participants Experiencing TEAEs
Time frame: From Week 1 up to Week 88
Percentage of Participants with TB Relapses and Re-infections During the Treatment-free Follow-up Phase
Time frame: During the treatment-free follow-up phase (Up to 48 weeks)
Percentage of Participants Whose Isolates Develop Resistance to Bedaquiline and Other Drugs Used in the Regimen
Time frame: Up to Week 88
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Derived from this study: PubMed 41925982Gao J, Huang Z, Ren F, Wu Y, Wang H, Wu G, Du J, Yan X, Pei Y, Jin L, Xiong Y, Shi L, Cui J, Chen X, Li X, Sha W, An H, Callewaert K, Lounis N, Bakare N, Jiang Y, Zhang R, Wang L, Gao M, Li L. Evaluation of an oral bedaquiline regimen for treating multidrug-resistant TB in China: a randomized trial. Infection. 2026 Jun;54(3):1265-1277. doi: 10.1007/s15010-026-02734-w. Epub 2026 Apr 2.
- Derived from this study: PubMed 38561815Gao J, Gao M, Du J, Pang Y, Mao G, Lounis N, Bakare N, Jiang Y, Zhan Y, Liu Y, Li L; Trial Team. A pragmatic randomized controlled trial to evaluate the efficacy and safety of an oral short-course regimen including bedaquiline for the treatment of patients with multidrug-resistant tuberculosis in China: study protocol for PROSPECT. Trials. 2024 Apr 1;25(1):227. doi: 10.1186/s13063-024-07946-9.
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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.
Mengqiu Gao principal investigator
Beijing Chest Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bedaquiline, Levofloxacin and Linezolid in people with Tuberculosis, Multidrug-Resistant, run by Beijing Chest Hospital at 17 sites in China.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingtao Gao, PhD (+8610-89509131, jingtaogao@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with a Favorable Treatment Outcome at the End of Treatment (time frame: At the end of treatment (Week 40)). 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 NCT05306223, 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 18 Jan 2023.