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Régimes de courte durée pour le traitement de la tuberculose pulmonaire (CRUSH-TB)

17 septembre 2026 mis à jour par: Centers for Disease Control and Prevention

Essai clinique de phase 2C de nouveaux schémas thérapeutiques de courte durée pour le traitement de la tuberculose pulmonaire : CRUSH-TB (régimes combinés pour raccourcir le traitement de la tuberculose)

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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

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

Hypotheses:

  1. 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.
  2. 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:

  1. 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.
  2. 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:

  1. To compare the proportion of participants with a grade 3 or higher adverse event in each experimental arm with the control arm
  2. 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.
  3. 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
  4. 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
  5. To describe the rate of all-cause study drug discontinuation in each arm
  6. To compare time to sputum culture positivity curves through 17 weeks in the Mycobacterial Growth Indicator Tube (Bactec MGIT960) across arms
  7. 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.
  8. To describe the population PK of bedaquiline and its M2 metabolite, with or without rifabutin co-administration (PK#1)
  9. 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:

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

Type d'étude

Interventionnel

Inscription (Estimé)

288

Phase

  • Phase 2
  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

12 ans et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. Pulmonary tuberculosis with or without suspected or proven concomitant extrapulmonary tuberculosis outside the central nervous system or bones

  2. 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".

  3. Age ≥12 years

  4. Documentation of negative HIV status within the past 3 months prior to enrollment or documentation confirming HIV infection.

  5. 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

  6. Written informed consent/assent

  7. Karnofsky score of at least 60 ("requiring some help, can take care of most personal requirements")

  8. 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.

  9. 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

  10. 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:

  1. Pregnant or breast-feeding

  2. More than 5 days of tuberculosis treatment in the previous 6 months

  3. 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

  4. Unable to take oral medications

  5. Hypersensitivity or previous intolerance to any of the study drugs

  6. Current or planned use of medications that have unacceptable drug-drug interactions with any of the study drugs during study treatment

  7. Suspected or proven central nervous system tuberculosis

  8. Suspected or proven bone tuberculosis

  9. 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)

  10. 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

  11. 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

  12. Known family history of Long QT Syndrome in a first-degree relative (i.e., parent, offspring, or sibling)

  13. History of aortic aneurysm or dissection

  14. Hepatic cirrhosis or other serious liver disease

  15. Other medical conditions, that, in the investigator's judgment, make study participation not in the individual's best interest.

  16. 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)

  17. Weight less than 40.0 kg

  18. Known or suspected resistance to isoniazid or rifamycins (by phenotypic or molecular test)

  19. 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

  20. Current or planned incarceration or other involuntary detention.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Médicament: 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)

Autres noms:
  • Rb-RBT
Médicament: Bedaquiline

Bedaquiline is part of interventional arms with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ).

Autres noms:
  • Sirturo
Médicament: Moxifloxacin

Moxifloxacin is part of interventional arms with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ).

Autres noms:
  • M
Médicament: Pyrazinamide

Pyrazinamide is part of interventional arms with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ). Pyrazinamide is part of control regimen (HRZE).

Autres noms:
  • Z-PZA
Expérimental: 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
Médicament: Bedaquiline

Bedaquiline is part of interventional arms with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ).

Autres noms:
  • Sirturo
Médicament: Moxifloxacin

Moxifloxacin is part of interventional arms with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ).

Autres noms:
  • M
Médicament: Pyrazinamide

Pyrazinamide is part of interventional arms with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ). Pyrazinamide is part of control regimen (HRZE).

Autres noms:
  • Z-PZA
Médicament: 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)

Autres noms:
  • Deltyba
Comparateur actif: 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
Médicament: Pyrazinamide

Pyrazinamide is part of interventional arms with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ). Pyrazinamide is part of control regimen (HRZE).

Autres noms:
  • Z-PZA
Médicament: Isoniazid

Isoniazid is part of control regimen (HRZE).

Autres noms:
  • H-INH
Médicament: Rifampin

Rifampin is part of control regimen (HRZE).

Autres noms:
  • R
Médicament: Ethambutol

Ethambutol is part of control regimen (HRZE).

Autres noms:
  • E

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Centers for Disease Control and Prevention

Collaborateurs

Tuberculosis Trials Consortium

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

21 novembre 2023

Achèvement primaire (Estimé)

31 décembre 2026

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

5 octobre 2022

Première soumission répondant aux critères de contrôle qualité

2 mars 2023

Première publication (Réel)

13 mars 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 7406

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Data being collected in CDISC format

Délai de partage IPD

After the study completion and during results submission

Critères d'accès au partage IPD

Upon request

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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