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Krátkodobé režimy pro léčbu plicní tuberkulózy (CRUSH-TB)

17. září 2026 aktualizováno: Centers for Disease Control and Prevention

Fáze 2C klinického hodnocení nových, krátkodobých režimů pro léčbu plicní tuberkulózy: CRUSH-TB (kombinované režimy pro zkrácení léčby TBC)

The purpose of this study is to determine whether one or two 17-week regimens of tuberculosis treatment bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ) plus either Rifabutin (Rb) or Delamanid (D or DLM) are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week.

The first 17-week regimen is 2 months of bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) plus rifabutin (Rb) (BMZRB) followed by 2 months of bedaquiline (B or BDQ), moxifloxacin (M) and Rifabutin (Rb) (2 BMZRb/2 BMRb, Arm 1)

The Second 17-week regimen is 2 months of bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) plus delamanid (D or DLM); (BMZD) followed by 2 months of bedaquiline (B or BDQ), moxifloxacin (M) and delamanid (D or DLM) (2 BMZD/2 BMD, Arm 2)

The standard 26-week treatment control regimen which is two months of isoniazid, rifampin, ethambutol, and pyrazinamide (2HRZE) followed by four months of isoniazid and rifampin (4HR); (2HRZE/4HR, Arm 3)

Target enrollment is 288 male and female participants (96/arm). participants. Participants will be followed until 78 weeks post-randomization, or until the last enrolled participant completes 52 weeks post-randomization, whichever comes first.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Detailní popis

Phase 2C Clinical Trial of Novel, Short-course Regimens for the Treatment of Pulmonary Tuberculosis: CRUSH-TB (Combination Regimens for Shortening TB Treatment)

Hypotheses:

The time to sputum culture negative in liquid media will be shorter in the 17-week regimen of 2 months of bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) plus rifabutin (Rb) followed by 2 months of bedaquiline (B or BDQ), moxifloxacin (M) and Rifabutin (Rb) (2BMZRb/2 BMRb, Arm 1) than in the control arm.
The time to sputum culture negative in liquid media will be shorter in the 17-week regimen of 2 months of bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z); (BMZ) plus delamanid (D or DLM) followed by 2 months of bedaquiline (B or BDQ), moxifloxacin (M) and delamanid (D or DLM) (2 BMZD/2 BMD, Arm 2) than in the control arm.

Phase: 3 Design: Open label, randomized clinical trial, initially in three treatment groups, with adaptive design allowing for introduction of novel regimens once they are clinically ready for testing Population: newly diagnosed with sputum smear positive or GeneXpert positive pulmonary tuberculosis, aged 12 years or older, with normal QTcF (QTc interval, Fridericia calculation) on screening ECG.

Number of Sites: 13 National and International sites, primarily sites of the Tuberculosis Trials Consortium Group. Study Duration: Duration per participant is approximately 78 weeks Description of Agent or Intervention: After written informed consent, participants will be randomized 1:1:1 to receive BMZRb, BMZD, or HRZE (Control treatment) as below

Arm 1(investigational regimen): 2 BMZRb/2 BMRb

Eight weeks of daily treatment with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), plus rifabutin (Rb), followed by
Nine weeks of daily treatment with bedaquiline (B or BDQ), moxifloxacin (M) and Rifabutin (Rb)

Arm 2 (investigational regimen): 2 BMZD/2 BMD

Eight weeks of daily treatment with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), plus delamanid (D or DLM) followed by
Nine weeks of daily treatment with bedaquiline (B or BDQ), moxifloxacin (M) and delamanid (D or DLM)

Arm 3 (Control regimen): 2 RHZE/4 RH

Eight weeks of daily treatment with rifampin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E), (RHZE) followed by
Eighteen weeks of daily treatment with rifampin and isoniazid (RH)

Objectives

Primary Objectives:

To compare the efficacy of 17-week regimen 8 weeks of bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) plus rifabutin (Rb) followed by 9 weeks of bedaquiline (B or BDQ), moxifloxacin (M) and rifabutin (Rb) (2 BMZRb/2 BMRb) experimental regimen to the efficacy of standard treatment, using the intermediate endpoint of time to culture negative in liquid media.
To compare the efficacy of 17-week regimen 8 weeks of bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) plus delamanid (D or DLM) followed by 9 weeks of bedaquiline (B or BDQ), moxifloxacin (M) and delamanid (D or DLM) (2 BMZD/2 BMD) experimental regimen to the efficacy of standard treatment, using the intermediate endpoint of time to culture negative in liquid media.

Secondary Objectives:

To compare the proportion of participants with a grade 3 or higher adverse event in each experimental arm with the control arm
To describe the proportion of participants experiencing lack of sustained cure during treatment or follow-up to 52 weeks in each experimental arm as compared to control and make predictions as to how these regimens would perform in future phase III trials.
To compare the efficacy of each experimental regimen to the efficacy of standard treatment, using the intermediate endpoint of time to culture negative in solid media
To compare the proportion of participants in each arm who convert liquid and solid sputum cultures to negative by (a) 8 weeks of treatment and (b) 12 weeks of treatment
To describe the rate of all-cause study drug discontinuation in each arm
To compare time to sputum culture positivity curves through 17 weeks in the Mycobacterial Growth Indicator Tube (Bactec MGIT960) across arms
To describe the proportion of participants experiencing lack of sustained cure during treatment or follow-up up to 78 weeks in each experimental arm as compared to control and make predictions as to how these regimens would perform in future phase III trials.
To describe the population PK of bedaquiline and its M2 metabolite, with or without rifabutin co-administration (PK#1)
To conduct pharmacokinetic/pharmacodynamics study of the test drugs to determine relationships between pharmacokinetic parameters (AUC, Cmax) and outcome measures (time to culture negativity or rate of change in TTP) using non-linear mixed effects models, adjusting for key covariates that may affect outcomes (e.g. companion drugs, HIV status, cavitary disease) (PK#2)

Primary Endpoints:

1. Time to sputum culture negative in liquid media

Secondary Endpoints:

Proportion of participants with a Grade 3 or higher adverse event during 26 weeks from randomization
Lack of sustained cure during treatment or follow-up to 52 weeks
Time to sputum culture negative in solid media
Proportion of participants with sputum culture negative by 8 weeks and by 12 weeks (solid and liquid media).
All-cause study drug discontinuation
The rate of change in time to sputum culture positivity (TTP) through 17 weeks in the Mycobacterial Growth Indicator Tube (Bactec MGIT960)
Lack of sustained cure during treatment or follow-up to 78 weeks
Population pharmacokinetics (PK) of bedaquiline, with or without rifabutin Pharmacokinetic/pharmacodynamic (PK/PD) relationship between test drug PK parameters and microbiologic outcomes

Typ studie

Intervenční

Zápis (Odhadovaný)

288

Fáze

Fáze 2
Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Haiti
- Ouest
  - Port-au-Prince, Ouest, Haiti, HT 6124
    - TBTC Site 67 GHESKIO centers IMIS
  - Port-au-Prince, Ouest, Haiti, HT6110
    - TBTC Site 45 Les Centres Gheskio (INLR)
Jižní Afrika
- Cape Town
  - Mowbray, Cape Town, Jižní Afrika, 7700
    - TBTC Site 09 University of Cape Town Lung Institute (Pty) Ltd
Kanada
- - Montreal, Kanada
    - McGill University Health Centre
  - Vancouver, Kanada
    - Vancouver, British Columbia Centre for Disease Control
Spojené státy
- Washington
  - Seattle, Washington, Spojené státy, 98104
    - TBTC Site 26 Seattle & King County TB Control Program
Uganda
- - Kampala, Uganda
    - TBTC Site 30 Uganda-Case Western Reserve Research Collaboration
Vietnam
- Can Tho City
  - Can Tho, Can Tho City, Vietnam, 70000
    - TBTC Site 76 CAB-V. Can Tho Province, Vietnam - Thot Not District TB Unit

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

12 let a starší (Dítě, Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

Pulmonary tuberculosis with or without suspected or proven concomitant extrapulmonary tuberculosis outside the central nervous system or bones
Acid-fast bacilli (AFB) seen in an expectorated sputum specimen at least 1+ or positive GeneXpert (or GeneXpert Ultra) for M. tuberculosis, with semiquantitative results of "medium" or "high".
Age ≥12 years
Documentation of negative HIV status within the past 3 months prior to enrollment or documentation confirming HIV infection.
For participants with HIV:
1. current use of dolutegravir-based ART (Anti Retroviral Therapy), or ability and willingness to start or transition to a dolutegravir-based antiretroviral therapy regimen
2. CD4 T cell count greater than or equal to 100 cells/mm3 based on testing performed at or within 30 days prior to study enrollment
Written informed consent/assent
Karnofsky score of at least 60 ("requiring some help, can take care of most personal requirements")
A verifiable address or residence location that is readily accessible for visiting, and willingness to inform the study team of any change of address during the treatment and follow-up period.
For all women who have not undergone a surgical sterilization procedure or who do not meet the study definition of post-menopausal, a negative pregnancy test at or within seven (7) days prior to screening
For all individuals of child-bearing potential who are not surgically sterilized, agreement to practice a reliable method of contraception (barrier method or non-hormonal intrauterine device) or abstain from sexual activity that could lead to pregnancy while receiving study drug treatment and for 30 days after stopping study treatment

Exclusion Criteria:

Pregnant or breast-feeding
More than 5 days of tuberculosis treatment in the previous 6 months
Previous treatment with any drug or combination of drugs known to have activity against M. tuberculosis (e.g., isoniazid, rifamycins, pyrazinamide, ethambutol, fluoroquinolones, etc.) for more than five days in the thirty days prior to enrollment
Unable to take oral medications
Hypersensitivity or previous intolerance to any of the study drugs
Current or planned use of medications that have unacceptable drug-drug interactions with any of the study drugs during study treatment
Suspected or proven central nervous system tuberculosis
Suspected or proven bone tuberculosis
Screening ECG with QTcF >450 for men or >470 for women (Note: in case of hypokalemia or hypomagnesemia, ECG can be repeated following electrolyte supplementation)
Clinically significant ECG abnormality in the opinion of the site investigator, including but not limited to second or third degree atrioventricular (AV) block, prolongation of the QRS complex over 120 ms (in both male and female participants), or clinically important arrhythmia
Current clinically relevant cardiovascular disorder in the opinion of the site investigator, including but not limited to heart failure, coronary heart disease, arrhythmia, or tachyarrhythmia
Known family history of Long QT Syndrome in a first-degree relative (i.e., parent, offspring, or sibling)
History of aortic aneurysm or dissection
Hepatic cirrhosis or other serious liver disease
Other medical conditions, that, in the investigator's judgment, make study participation not in the individual's best interest.
Laboratory parameters done at or within 14 days prior to screening:
1. Serum or plasma alanine aminotransferase greater than 3 times the upper limit of normal
2. Serum or plasma total bilirubin greater than 2.5 times the upper limit of normal
3. Serum creatinine > 2 times the upper limit of normal
4. Platelet count < 75,000 cells/mm3
5. Absolute neutrophil count <1,000 cells/mm3
6. Serum or plasma potassium <3.5 meq/L (note: potassium may be repleted and test repeated)
Weight less than 40.0 kg
Known or suspected resistance to isoniazid or rifamycins (by phenotypic or molecular test)
Previously enrolled in this study or currently enrolled in another therapeutic clinical trial that, in the investigator's judgment, would compromise study integrity or participant safety
Current or planned incarceration or other involuntary detention.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Primární účel: Léčba
Přidělení: Randomizované
Intervenční model: Paralelní přiřazení
Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm Skupina účastníků / Arm Skupina nebo podskupina účastníků klinické studie, která podle protokolu studie dostává konkrétní intervenci/léčbu nebo žádnou intervenci.	Intervence / Léčba Intervence / Léčba Proces nebo akce, na které se klinická studie zaměřuje. Intervence zahrnují léky, zdravotnická zařízení, postupy, vakcíny a další produkty, které jsou buď zkoušené nebo již dostupné. Intervence mohou také zahrnovat neinvazivní přístupy, jako je edukace nebo úprava stravy a cvičení.
Experimentální: 2BMZRb/2 BMRb Eight weeks of daily treatment with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), plus rifabutin (Rb), followed by nine weeks of daily treatment with bedaquiline (B or BDQ), moxifloxacin (M) and Rifabutin (Rb) All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered once daily. Study drug doses: Bedaquiline (B): 200 mg once daily x 56 days, then 100 mg daily; Moxifloxacin (M): 400 mg once daily; Pyrazinamide (Z) 1500 mg (weight <75kg) or 2000mg(> 75kg) once daily x 56 days; Rifabutin (Rb): 300 mg once daily	Lék: Rifabutin Rifabutin (Rb) is added to the bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) regimen for first 8 weeks and continued for next 9 weeks with bedaquiline (B or BDQ) and moxifloxacin (M) Ostatní jména: Rb-RBT Lék: Bedaquiline Bedaquiline is part of interventional arms with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ). Ostatní jména: Sirturo Lék: Moxifloxacin Moxifloxacin is part of interventional arms with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ). Ostatní jména: M Lék: Pyrazinamide Pyrazinamide is part of interventional arms with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ). Pyrazinamide is part of control regimen (HRZE). Ostatní jména: Z-PZA
Experimentální: 2 BMZD/2 BMD Eight weeks of daily treatment with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), plus delamanid (D or DLM) followed by nine weeks of daily treatment with bedaquiline (B or BDQ), moxifloxacin (M) and delamanid (D or DLM) All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered once daily. Study drug doses: Bedaquiline (B): 200 mg once daily x 56 days, then 100 mg daily; Moxifloxacin (M): 400 mg once daily; Pyrazinamide (Z) 1500 mg (weight <75kg) or 2000mg(> 75kg) once daily x 56 days; Delamanid (D):300 mg once daily	Lék: Bedaquiline Bedaquiline is part of interventional arms with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ). Ostatní jména: Sirturo Lék: Moxifloxacin Moxifloxacin is part of interventional arms with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ). Ostatní jména: M Lék: Pyrazinamide Pyrazinamide is part of interventional arms with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ). Pyrazinamide is part of control regimen (HRZE). Ostatní jména: Z-PZA Lék: Delamanid Delamanid (D or DLM) is added to the bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) regimen for first 8 weeks and continued for next 9 weeks with bedaquiline (B or BDQ) and moxifloxacin (M) Ostatní jména: Deltyba
Aktivní komparátor: 2RHZE/4RH Eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by eighteen weeks of daily treatment with rifampin and isoniazid All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered once daily study drug doses: Rifampin (R), 600 mg daily; Isoniazid (H), 300 mg daily; Pyrazinamide (Z) 1500 mg (weight <75kg) or 2000mg(> 75kg) once daily ; Ethambutol, 15 mg/kg once daily rounded up to nearest 400 mg dose	Lék: Pyrazinamide Pyrazinamide is part of interventional arms with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ). Pyrazinamide is part of control regimen (HRZE). Ostatní jména: Z-PZA Lék: Isoniazid Isoniazid is part of control regimen (HRZE). Ostatní jména: H-INH Lék: Rifampin Rifampin is part of control regimen (HRZE). Ostatní jména: R Lék: Ethambutol Ethambutol is part of control regimen (HRZE). Ostatní jména: E

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Time to sputum culture negative in liquid media after study treatment among participants in Experimental Regimens (2 BZMRb/ 2 BMRb, Arm 1) and (2 BMZD/ 2 BMD, Arm 2) compared to Control (2HRZE/4HR, Arm 3) in modified intention-to-treat group (ITT) Časové okno: 17 weeks	The purpose of this study is to determine whether one or two 17-week regimens of tuberculosis treatment bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ) plus either Rifabutin (Rb) or Delamanid (D or DLM) are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week. The time to culture negative will be defined as the time from randomization to the date of the first of at least two consecutive negative sputum cultures, collected on different study visits, irrespective of any subsequent positive cultures that may occur. Modified intention-to-treat group includes all participants in the ITT population (all enrolled participants who receive a treatment assignment) except late exclusions	17 weeks

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
The proportion of participants with a grade 3 or higher adverse event in Experimental Regimens (2 BZMRb/2 BMRb, Arm 1) and (2 BMZD/2 BMD, Arm 2) compared to Control Regimen (2HRZE/4HR, Arm 3) in the modified intention-to-treat group Časové okno: up to 78 weeks	To evaluate the safety of one or two 17-week regimens of tuberculosis treatment bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ) plus either Rifabutin (Rb) or Delamanid (D or DLM) are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week. Safety Analysis includes all participants in the ITT population that receive at least one dose of study medication	up to 78 weeks
The proportion of participants experiencing lack of sustained cure in each experimental regimens (2BZMRb/2BMRb, Arm 1) and (2BMZD/2BMD, Arm 2) compared to Control Regimen (2HRZE/4HR, Arm 3) Časové okno: up to 52 weeks	Sustained Culture Negativity is achieved when a participant's last two culture results collected on different study visits are negative (without an intervening positive result), the last of which is collected no earlier than 48 weeks after randomization (allowing for a 4 week window prior to the 52 week timepoint	up to 52 weeks
The proportion of participants experiencing lack of sustained cure in each experimental regimens (2BZMRb/2BMRb, Arm 1) and (2BMZD/2BMD, Arm 2) compared to Control Regimen (2HRZE/4HR, Arm 3) Časové okno: up to 78 weeks	Sustained Culture Negativity is achieved when a participant's last two culture results regimens (2BZMRb/2BMRb, Arm 1) and (2BMZD/2BMD, Arm 2) compared to Control Regimen (2HRZE/4HR, Arm 3)collected on different study visits are negative (without an intervening positive result), the last of which is collected no earlier than 48 weeks after randomization (allowing for a 4 week window prior to the 52 week timepoint	up to 78 weeks
Time to sputum culture negative in solid media after study treatment assignment among participants in Experimental Regimens (2BZMRb/2BMRb, Arm 1) and (2BMZD/2BMD, Arm 2) compared to Control Regimen (2HRZE/4HR, Arm 3) in modified intention-to-treat group Časové okno: up to 78 weeks	The purpose of this study is to determine whether one or two 17-week regimens of tuberculosis treatment bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ) plus either Rifabutin (Rb) or Delamanid (D or DLM) are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week. The time to culture negative will be defined as the time from randomization to the date of the first of at least two consecutive negative sputum cultures, collected on different study visits, irrespective of any subsequent positive cultures that may occur. Modified intention-to-treat group includes all participants in the ITT population (all enrolled participants who receive a treatment assignment) except late exclusions	up to 78 weeks
Proportion of participants with sputum culture negative by 8 weeks and by 12 weeks (solid and liquid media) in all 3 regimens Časové okno: 8 weeks and 12 weeks	The time to culture negative will be defined as the time from randomization to the date of the first of at least two consecutive negative sputum cultures, collected on different study visits, irrespective of any subsequent positive cultures that may occur	8 weeks and 12 weeks
All-cause study drug discontinuation among participants in experimental regimens compared to control regimen Časové okno: up to 26 weeks	Any discontinuation in study treatment by the participant	up to 26 weeks
The rate of change in time to sputum culture positivity (TTP) through 17 weeks in the Mycobacterial Growth Indicator Tube (Bactec MGIT960) among participants in all three regimens Časové okno: 17 weeks	rate of change in time to sputum culture positivity (TTP) through 17 weeks in the Mycobacterial Growth Indicator Tube (Bactec MGIT960) will be measured and compared	17 weeks
Clearance of bedaquiline Časové okno: 17 weeks	Population PK parameter, Clearance of bedaquiline with or without rifabutin co-administration, will be measured for each experimental arm	17 weeks
Volume of Distribution of bedaquiline Časové okno: 17 weeks	Population PK parameter, Volume of Distribution of bedaquiline with or without rifabutin co-administration, will be measured for each experimental arm	17 weeks
Rate of absorption of bedaquiline Časové okno: 17 weeks	Population PK parameter: rate of absorption of bedaquiline with or without rifabutin co-administration, will be measured for each experimental arm	17 weeks

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Centers for Disease Control and Prevention

Spolupracovníci

Tuberculosis Trials Consortium

Vyšetřovatelé

Studijní židle: Ekaterina V Kurbatova, MD, PhD, MPH, Centers for Disease Control and Prevention
Studijní židle: Kelly Dooley, MD, Johns Hopkins University
Studijní židle: Daniel W Fitzgerald, MD, Weill Medical College of Cornell University
Studijní židle: Wendy Carr, PhD, Centers for Disease Control and Prevention

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Kurbatova EV, Dooley KE, Carr W, Stout JE, Nuermberger EL, Phillips PPJ, Scott NA, Upton CM, Ignatius E, Haas M, Walter ND, Traxler RM, Brown NE, Boyd R, Bryant KE, Dixon MG, Savic R, Eichberg C, Hesseling A, Bark C, Benator DA, Muzanyi G, Twycross NS, Fox GJ, Pierre S, Burzynski J, Fitzgerald DW; TBTC Study 38 CRUSH-TB Team. Phase 2C clinical trial of novel short-course regimens for the treatment of pulmonary tuberculosis: TBTC study 38/CRUSH-TB design. Contemp Clin Trials. 2025 Nov;158:108075. doi: 10.1016/j.cct.2025.108075. Epub 2025 Sep 5.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

21. listopadu 2023

Primární dokončení (Odhadovaný)

31. prosince 2026

Dokončení studie (Odhadovaný)

31. prosince 2027

Termíny zápisu do studia

První předloženo

5. října 2022

První předloženo, které splnilo kritéria kontroly kvality

2. března 2023

První zveřejněno (Aktuální)

13. března 2023

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

7406

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Data being collected in CDISC format

Časový rámec sdílení IPD

After the study completion and during results submission

Kritéria přístupu pro sdílení IPD

Upon request

Typ podpůrných informací pro sdílení IPD

PROTOKOL STUDY
ICF

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

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Krátkodobé režimy pro léčbu plicní tuberkulózy (CRUSH-TB)

Fáze 2C klinického hodnocení nových, krátkodobých režimů pro léčbu plicní tuberkulózy: CRUSH-TB (kombinované režimy pro zkrácení léčby TBC)

Přehled studie

Postavení

Podmínky

Intervence / Léčba

Detailní popis

Typ studie

Zápis (Odhadovaný)

Fáze

Kontakty a umístění

Studijní místa

Kritéria účasti

Kritéria způsobilosti

Věk způsobilý ke studiu

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Popis

Studijní plán

Jak je studie koncipována?

Detaily designu

Počet zbraní

Zbraně a zásahy

Skupina účastníků / Arm

Intervence / Léčba

Co je měření studie?

Primární výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Sekundární výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Spolupracovníci a vyšetřovatelé

Sponzor

Spolupracovníci

Vyšetřovatelé

Publikace a užitečné odkazy

Obecné publikace

Termíny studijních záznamů

Hlavní termíny studia

Začátek studia (Aktuální)

Primární dokončení (Odhadovaný)

Dokončení studie (Odhadovaný)

Termíny zápisu do studia

První předloženo

První předloženo, které splnilo kritéria kontroly kvality

První zveřejněno (Aktuální)

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

Naposledy ověřeno

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Popis plánu IPD

Časový rámec sdílení IPD

Kritéria přístupu pro sdílení IPD

Typ podpůrných informací pro sdílení IPD

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Studuje produkt zařízení regulovaný americkým úřadem FDA