Tuberculosis Clinical Trial
— TEDITUBOfficial title:
Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis
NCT number | NCT05534750 |
Other study ID # | APHP210084 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 20, 2023 |
Est. completion date | May 2025 |
The objective of this work is to measure the early bactericidal activity of tedizolid, to compare it with the bactericidal activity of linezolid (reference molecule for the treatment of multidrug-resistant tuberculosis) and with that of standard quadruple therapy (reference treatment of drug susceptible tuberculosis).
Status | Recruiting |
Enrollment | 60 |
Est. completion date | May 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age = 18 years old and <75 years old - Woman on childbearing age should be on effective contraception during the duration of the study and up to 6 months after treatment; a mechanical contraception (use of condom) will be strongly recommended - Male (effective contraception must be used during duration of the study and up to 3 months after treatment) - Patient with a first infection with Mycobacterium tuberculosis of pulmonary localization suspected by the presence of a clinical pulmonary symptomatology, a chest X-ray or an abnormal chest computed tomography, and the positive microscopic examination of a sputum (AFB +, presence of AFB) with confirmation of tuberculosis by a genotypic test demonstrating no resistance to rifampicin, without clinical signs of extra-thoracic involvement - State medical assistance application being processed ( If patient does not benefit from social security), - Signature of informed consent Exclusion Criteria: - Resistance to one of the anti-tuberculosis drugs used detected by a genotypic test in accordance with the recommendations of the High Council of Public Health of 2015; - History of anti-tuberculosis treatment; - History of treatment in the previous two years with one of the antibiotics evaluated in this trial lasting more than one month; - Absolute contraindication to the use of at least one of the test molecules (isoniazid, rifampicin, ethambutol, pyrazinamide, linezolid, tedizolid); - Tuberculosis having, in the opinion of the investigator, severity criteria not allowing to wait 7 days before starting standard treatment (oxygenorequirement, severe immunosuppression, extra-pulmonary involvement, any sign of severity requiring treatment in intensive care unit); - HIV-infected patient receiving protease inhibitors whose antiviral treatment cannot be changed and therefore cannot receive rifampicin; or any other drug contraindicated with one of the study treatments (the list of contraindicated drugs is detailed in the following non-inclusion criteria). - Neoplastic pathology during treatment with chemo and / or radiotherapy; - Decompensated cirrhosis; - Pregnancy, desire to become pregnant, breast-feeding (for women of childbearing potential, contraception should be used for the duration of the study and up to 6 months after treatment, mechanical contraception will be strongly recommended and up to 3 months after treatment); - Protected adults (under guardianship, curatorship) and under safeguard of justice - Significant laboratory abnormalities (hemoglobin <9g / dl, polynuclear neutrophils <500 / mm3, platelets <50,000 / mm3, creatinine clearance <30ml / min, ASAT or ALAT> 3N, and total bilirubin> 3N) - Hyperuricaemia - Porphyria - Optic neuritis or peripheral neuropathy - BMI= 16 kg/m2 - Participation in other interventional research - Current treatment with one or more medications contraindicated in combination with linezolid: Linezolid should not be used in patients treated with monoamine oxidase A or B inhibitors (for example: phenelzine, isocarboxacid, selegiline, moclobemide) or who received one of these products in the previous two weeks - Current treatment with one or more medications contraindicated in combination with quadritherapy: - Combination with bictegravir, cobicistat, daclatasvir, dasabuvir, delamanid, grazoprevir/elbasvir, protease inhibitors boosted by ritonavir, isavuconazole, ledipasvir, lurasidone, midostaurin, ombitasvir/paritaprevir, praziquantel, rilpivirine, sofosbuvir, velpatasvir, voriconazole, voxilaprevir - Gastrointestinal topicals, antacids and adsorbents and salts and aluminum hydroxides |
Country | Name | City | State |
---|---|---|---|
France | Bacteriology department- Hôpital Saint-Antoine | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of the early bactericidal activity (EBA) of tedizolid (200mg / day) at the end of the first 2 days of treatment (D3). | The measurement will be done as follow: EABD1D3= (log10 number of CFU (CFU= colony forming unit) of M. tuberculosis on medium 7H11/mL of sputum on D1) - (log10number of CFU of M. tuberculosis on medium 7H11/mL of sputum on D3)/2. | Day 3 | |
Secondary | Evaluation of the early bactericidal activity (EBA) of tedizolid between Day 3 and Day 8 | The measurement will be done as follow: EBAD3D8= (log10 number of CFU (CFU=colony forming unit) of M. tuberculosis on medium 7H11/mL of sputum on D3) - ( log10 number of CFU of M. tuberculosis on medium 7H11/mL of sputum at D8)/5 | Day 8 | |
Secondary | Comparison of the early bactericidal activity (EBA) of tedizolid between Day 1 and Day 3 | Compare the early bactericidal activity of tedizolid 200 mg / day to that of linezolid 1200 mg / day between Day 1 and Day 3 | Day 3 | |
Secondary | Comparison of the early bactericidal activity (EBA) of tedizolid between Day 3 and Day 8 | Compare the early bactericidal activity of tedizolid 200 mg / day to that of linezolid 1200 mg / day between Day 1 and Day 3 and between Day 3 and Day 8 | Day 8 | |
Secondary | Comparison of the early bactericidal activity of tedizolid 200 mg / day to that of standard quadruple therapy between Day 1 and Day 3 | Compare the early bactericidal activity of tedizolid 200 mg / day to that of standard quadruple therapy between Day 1 and Day 3 | Day 3 | |
Secondary | Comparison of the early bactericidal activity of tedizolid 200 mg / day to that of standard quadruple therapy between Day 3 and Day 8 | Compare the early bactericidal activity of tedizolid 200 mg / day to that of standard quadruple therapy between Day 3 and Day 8 | Day 8 | |
Secondary | Tedizolid pharmacokinetics'measurement | To measure the total and free concentration of tedizolid measured at 0, 1, 3, 5 and 24hours | 24hours | |
Secondary | Evaluation of Tedizolid's tolerance on hemoglobin | Rate of patients with hemoglobin <9, g / dl, which will lead to premature discontinuation of the administration of the treatment | 30 days | |
Secondary | Evaluation of Tedizolid's tolerance on polynuclear neutrophils | Rate of patients with polynuclear neutrophils <500 / mm3, which will lead to premature discontinuation of the administration of the treatment | 30 days | |
Secondary | Evaluation of Tedizolid's tolerance on platelets | Rate of patients with platelets <30,000 / mm3 which will lead to premature discontinuation of the administration of the treatment | 30 days | |
Secondary | Evaluation of Tedizolid's tolerance on creatinine clearance | Rate of patients with creatinine clearance <30ml / min which will lead to premature discontinuation of the administration of the treatment | 30 days | |
Secondary | Evaluation of Tedizolid's tolerance on AST/ALT | Rate of patients with AST or ALT> 5N which will lead to premature discontinuation of the administration of the treatment | 30 days | |
Secondary | Evaluation of Tedizolid's tolerance on bilirubin | Rate of patients with total bilirubin> 5N which will lead to premature discontinuation of the administration of the treatment | 30 days | |
Secondary | Evaluation of Tedizolid's tolerance on dress syndrome | Rate of patients with dress syndrome which will lead to premature discontinuation of the administration of the treatment. | 30 days | |
Secondary | Evaluation of Tedizolid's tolerance on optic neuropathy | Rate of patients with optic neuropathy which will lead to premature discontinuation of the administration of the treatment | 30 days | |
Secondary | Evaluation of Tedizolid's tolerance on peripheral neuropathy | Rate of patients with rapidly progressive peripheral neuropathy, which will lead to premature discontinuation of the administration of the treatment | 30 days |
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