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L'essai clinique NCT06081361 (INSPIRE-CODA) pour Tuberculose pulmonaire, Rifampicin-resistant Tuberculosis est actif, ne recrute pas. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Vue en carte
Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort (INSPIRE-CODA) Phase III 186
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT06081361 (INSPIRE-CODA) est conçu pour étudier le traitement de Tuberculose pulmonaire, Rifampicin-resistant Tuberculosis. Il s'agit d'une étude interventionnel en Phase III. Son statut actuel est : actif, ne recrute pas. L'étude a débuté le 22 décembre 2023 et vise à recruter 186 participants. Dirigée par Beijing Chest Hospital, l'étude devrait être terminée d'ici le 31 décembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 1 avril 2025.
Résumé succinct
The goal of this clinical trial is to compare the efficacy and safety of a Contezolid and Delamanid-Containing short regimen to standard longer regimen in Rifampicin-resistant pulmonary tuberculosis (RR-TB). The main questions it aims to answer are:
- Is the efficacy of short regimen non-inferior to standard regimen?
- Is the short regimen safe enough to replace the standard regimen?
Participants will:
- Be given ...
Titre officiel
A Multicenter, Randomized, Open-Label Study To Evaluate The Efficacy And Safety Of A Contezolid, Delamanid and Bedaquiline-Containing Short Regimen For The Treatment Of Rifampicin-Resistant Pulmonary Tuberculosis
Pathologies
Tuberculose pulmonaireRifampicin-resistant TuberculosisAutres identifiants de l'étude
- INSPIRE-CODA
- BJCH-202301
Numéro NCT
Date de début (réel)
2023-12-22
Dernière mise à jour publiée
2025-04-01
Date de fin (estimée)
2026-12-31
Inscription (estimée)
186
Type d'étude
Interventionnel
PHASE
Phase III
Statut
Actif, ne recrute pas
Mots clés
tuberculosis
Rifampicin-resistant
short regimen
contezolid
delamanid
Rifampicin-resistant
short regimen
contezolid
delamanid
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalShort-Term Regimen Intervention will be determined based on Fluoroquinolones(FQs) resistance.
* For those sensitive to FQs: BDQ DLM CZD LFX(MFX) for 6 months
* For those resistant to FQs: BDQ DLM CZD CFZ for 6 months | Bedaquiline Oral, 400mg qd for 2 weeks, then 200 mg 3 times per week Delamanid Oral, 100mg bid Contezolid Oral, 800mg bid Levofloxacin Oral, 400mg qd for weight \<50kg, 600-750mg qd for weight ≥50kg Moxifloxacin Oral, 400mg qd Clofazimine Oral, 100mg qd |
Comparateur actifStandard Regimen Intervention will be determined based on Fluoroquinolones(FQs) resistance.
* For those sensitive to FQs: BDQ LZD LFX(MFX) CS CFZ regimen for 6 months, then LFX(MFX) CS CFZ for 12 months
* For those resistant to FQs: LFX(MFX) will be replaced by Pto, PZA, PAS or EMB | Bedaquiline Oral, 400mg qd for 2 weeks, then 200 mg 3 times per week Levofloxacin Oral, 400mg qd for weight \<50kg, 600-750mg qd for weight ≥50kg Moxifloxacin Oral, 400mg qd Clofazimine Oral, 100mg qd Linezolid Oral, 600mg qd Cycloserine Oral, 250mg bid Prothionamide Oral, 600mg qd for weight \<50kg, 600-800mg qd for weight ≥50kg Pyrazinamide Oral, 1500mg qd for weight \<50kg, 1750mg qd for weight ≥50kg Para-Aminosalicylic Acid 8000mg qd for weight \<50kg, 10000mg qd for weight ≥50kg Ethambutol 750mg qd for weight \<50kg, 1000mg qd for weight ≥50kg |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Favourable outcome rate at 24 months after randomization | The proportion of participants with a favourable outcome. A participant's outcome will be classified as favourable if their last two sputum culture results are negative unless they have previously been classified as unfavourable. These two cultures must be taken on separate visits (with ≥28d interval); the latest of which not being earlier than month 23 from randomization. | from randomization to 24 months after |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Unfavourable outcome rate at 24 months after randomization | Including
1. Death;
2. Treatment failure
3. Lost-to-follow-up
4. Treatment Discontinuation
5. Ttreatment prolonging
6. Still on treatment at the end of follow up
7. Recurrence | from randomization to 24 months after |
Time to culture conversion | Time from treatment initiation to first negative result in sputum culture confirmed by two consecutive cultures with an interval of ≥28d | from randomization to 24 months after |
Grade 3 or higher adverse event rate | Proportion of participants experiencing at least one grade 3 or higher adverse event, or serious adverse event defined by the Division of AIDS severity criteria for adverse events | from randomization to 24 months after |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- Age ≥18y and <70y when signing informed consent;
- Initial or re-treatment for pulmonary tuberculosis with:
1) MTB positive in sputum or bronchoalveolar lavage fluid culture at or within 3 months before screening, or MTB positive in molecular test at or within 3 months before screening, and; 2) recorded Rifampicin-resistance at or before screening; 3. Imaging (Chest X-ray or CT scan) proved pulmonary tuberculosis within 1 year before screening; 4. Never used BDQ, DLM or CZD, or the accumulative duration of any of the treatment is not more than 2 weeks 5. For women in childbearing age, negative in pregnancy test and effective contraceptive measures throughout study is required; 6. For men, effective contraceptive measures is required; 7. Willing to participate the study and sign informed consent.
- The participant will be excluded by investigator based on the medical history or concomitant diseases such as serious metabolic disease, cardiovascular disease, hepatobiliary disease, renal disease, autoimmune disease, neuropsychiatric disorders, hematological disease, malignant neoplastic disease and so on; or the study will have negative impact on the well-being of the participant, or the participant is considered unable to complete the evaluation by investigator;
- History of alcohol or drug abuse that the study is considered have negative impact on the well-being of the participant by investigator;
- HIV positive;
- Chronic hepatitis with HBsAg, HBeAg and anti-HBC antibody positive, or HBV-DNA>1000 CPs/mL with rising ALT/AST;
- Allergic to or known hypersensitive to any of study drugs;
- Extensive (or advanced) pulmonary TB disease: presence of bilateral cavitary disease or extensive parenchymal damage on chest radiography;
- Hematogenous disseminated pulmonary tuberculosis and serious extrapulmonary tuberculosis (such as tuberculosis in digestive system, urogenital system, osteoarticular tuberculosis, tuberculous meningitis);
- With any of following risk factors for cardiovascular disease: 1) history of arrhythmia and on consequential treatment; 2) QTcF>500ms on ECG; 3) history of ventricular arrhythmia; 4) torsade de pointe with heart failure, hypokalemia or familial long Q-T syndrome; 5) other possible risk factor for arrythmia;
- Previous or current optic nerve disorder that may progress or deteriorate during the study by investigator's consideration;
- Was enrolled within 2 months before screening, or currently in other studies; except for those who participating observational study or in the post-treatment period;
- Being considered unlikely to survive for more than 6 months by investigator;
- BMI < 17kg/m2
- May need surgical procedures based on the evaluation of pulmonary lesions;
- May continuous use prohibited concomitant medications that is considered not suitable for the study by investigator;
- Positive in pregnancy test or known pregnancy, breastfeeding, or plan to become pregnant during or within 6 months after the study treatment;
- Abnormal laboratory test results: 1) Plasma potassium lower than lower limit of normal (LLN); 2) Hb < 8.0 g/dL； 3) platelet count <75,000/mm3； 4) WBC count<3000/mm3； 5）AST/ALT >3×ULN； 6）creatinine>2×ULN；7）total bilirubin>2×ULN, or >1.5×ULN，with abnormal AST or ALT; 8) Albumin < 30g/L
Beijing Chest HospitalNational Medical Center for Infectious DiseasesPartie responsable de l'étude
Chu naihui, Investigateur principal, Professor, Beijing Chest Hospital
Aucune donnée de contact disponible
39 Centres de l'étude dans 1 pays
Beijing Municipality
Beijing Chest Hospital affiliated to Capital Medical University, Beijing, Beijing Municipality, 101149, China
China
Changsha Central Hospital, Changsha, China, China
Anhui Chest Hospital, Hefei, China, China
Jiamusi Tumor Hospital, Jiamusi, China, China
Shandong public health clinical center, Shandong, China, China
Xi'an Chest Hospital, Xi'an, China, China
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China, China
Hebei
Hebei Chest Hospital, Shijiazhuang, Hebei, 050000, China
Heilongjiang
Harbin Chest Hospital, Harbin, Heilongjiang, 150000, China
Inner Mongolia
Infectious Disease Hospital of Hulunbuir, Hulunbuir, Inner Mongolia, China
Shandong
Qingdao Chest Hospital, Qingdao, Shandong, 266000, China
Shanxi
Taiyuan Fourth People's Hospital, Taiyuan, Shanxi, 030000, China
The 8th Medical Center of Chinese Pla General Hospital, Beijing, China
Hunan Province Chest Hospital, Changsha, China
Chongqing Public Heath Treatment Center, Chongqing, China
Dalian Public Health Center, Dalian, China
Fuzhou Pulmonary Hospital of Fujian, Fuzhou, China
Guangzhou Chest Hospital, Guangzhou, China
Heilongjiang Province center for tuberculosis Control and Prevention, Haerbin, China
Second Affiliated Hospital of Hainan Medical University, Haikou, China
Hangzhou Red Cross Hospital, Hangzhou, China
Second People's Hospital of Hohhot, Hohhot, China
Jiamusi Infectious Disease Hospital, Jiamusi, China
Jilin Tuberculosis Hospital, Jilin, China
People's Hospital of Linyi, Linyi, China
Second Hospital of Nanjing, Nanjing, China
Fourth People's Hospital of Nanning, Nanning, China
Guangxi Chest Hospital, Nanning, China
National Medical Center for Infectious Disease, Shanghai, China
Affiliated Hospital of Shaoxing University, Shaoxing, China
Shenyang Chest Hospital, Shenyang, China
Shijiazhuang Fifth Hospital, Shijiazhuang, China
Tianjin Haihe Hospital, Tianjin, China
The 8th Affiliated Hospital of Xinjiang Medical University, Ürümqi, China
Second People's Hospital of Weifang, Weifang, China
Wuhan Institute For Tuberculosis Control, Wuhan, China
First Affiliated Hospital of Xiamen Medical University, Xiamen, China
Henan Provincial Chest Hospital, Zhengzhou, China
Affiliated Hospital of Zunyi Medical University, Zunyi, China