TuberculosisPhase 2TEDITUBNCT05534750
Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)
A Phase 2 study testing Tedizolid arm (SIVEXTRO®), Linezolid arm (ZYVOXID®) and Standard quadruple therapy arm in people with Tuberculosis and Multidrug Resistant Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tuberculosis, Multidrug Resistant Tuberculosis
- What is being tested?
- Tedizolid arm (SIVEXTRO®), Linezolid arm (ZYVOXID®) and Standard quadruple therapy arm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2023to May 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 (patients with a documented negative genotypic test for isoniazid and rifampicin resistance may be included)
- 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).
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Bacteriology department- Hôpital Saint-Antoine
Paris, 75012
Nicolas VEZIRIS, PU-PH, 01 49 28 30 41, nicolas.veziris@aphp.fr
Ruxandra CALIN, MD, 01 56 01 74 12, ruxandra.calin@aphp.fr
About this study
Official title: Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis
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).
Read the detailed description
This is a Phase 2, prospective, randomized, open-label controlled trial in 3 parallel groups comparing tedizolid with 2 standard treatments: linezolid (oxazolidinone whose anti-tuberculosis activity has already been demonstrated) and standard treatment for tuberculosis (quadruple therapy: isoniazid, rifampicin, ethambutol, pyrazinamide ). The objective is to measure the early bactericidal activity of tedizolid, to compare it with the bactericidal activity of linezolid and with that of standard quadruple therapy.
Design: A multicentric, open-label, randomized clinical trial
Sample size : 60 patients, 20 in each group
Treatments groups:
- Tedizolid arm:
- Tedizolid (SIVEXTRO®),
- 200 mg film-coated tablet
- Dosage of 1 tablet per day to be taken in the morning for 7 days (taken with or without meals).
- Linezolid arm (ZYVOXID®):
- Linezolid arm (ZYVOXID®)
- 600 mg film-coated tablet
- Dosage of 2 tablets per day to be taken in the morning for 7 days (taken with or without meals).
- Standard quadruple therapy arm:
- Isoniazid (RIMIFON®) Tablets 50 or 200 mg Dosage 3 to 5mg / kg / day for 7 days to be taken in the morning on an empty stomach.
- Rifampicin, dosage 10mg / kg / day for 7 days to be taken in the morning on an empty stomach.
- Ethambutol 15-20mg / kg / day for 7 days to be taken in the morning on an empty stomach.
- Pyrazinamide 20-25mg / kg / day for 7 days to be taken in the morning on an empty stomach.
Treatment duration : 7 days
Assessement:
After signing the consent, patients will be randomized, a sputum sample will be taken before the first drug intake. Then, patients will be treated for 7 days depending on the randomization group (tedizolid, linezolid or standard quadruple therapy). Daily, a sputum of at least 2 mL will be withdrawn from the patients for 7 days.
A consultation with blood test will be carried out on D30, date of the patient's end of participation.
No interim analysis is planned. Analysis will be performed at the end of the study after data review and freezing of database.
- Conditions
- Tuberculosis, Multidrug Resistant Tuberculosis
- Being tested
- Tedizolid arm (SIVEXTRO®), Linezolid arm (ZYVOXID®), Standard quadruple therapy arm
- Keywords
- Tuberculosis, Multidrug Resistant, Linezolid, Tedizolid, Pyrazinamide, Rifampicin, Isionazid, Ethambutol, Early Bactericidal Activity
- Medical subject headings
- Tuberculosis, Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tedizolid arm (SIVEXTRO®)Drug
Patients will be taken 1 tablet per day of 200 mg film-coated of Tedizolid (SIVEXTRO®), in the morning for 7 days. Then, the early bactericidal activity will be measured and compared to the other arms.
Linezolid arm (ZYVOXID®)Drug
Patients will be taken 2 tablets per day of 600 mg film-coated of Linezolid (ZYVOXID®) in the morning for 7 days. Then, the early bactericidal activity will be measured and compared to the other arms.
Standard quadruple therapy armDrug
Patients will be taken :
ISONIAZIDE :
- A dosage of 5mg / kg / day for 7 days (to be taken in the morning on an empty stomach) of Isoniazid (RIMIFON®)
RIFAMPICINE :
- A dosage of 10mg / kg / day for 7 days (to be taken in the morning on an empty stomach)
ETHAMBUTOL :
- A dosage of 15-20mg / kg / day for 7 days (to be taken in the morning on an empty stomach) of Ethambutol
PYRAZAMIDE :
- A dosage of 20-25mg / kg / day for 7 days (to be taken in the morning on an empty stomach) of Pyrazinamide
Then, the early bactericidal activity will be measured and compared to the other arms.
| Study group | Role | What they receive |
|---|---|---|
| Tedizolid arm | Experimental | Patients will be taken 1 tablet per day of 200 mg film-coated of Tedizolid (SIVEXTRO®), in the morning for 7 days. Then, the early bactericidal activity will be measured and compared to the other arms. Receives: Drug: Tedizolid arm (SIVEXTRO®) |
| Linezolid arm | Experimental | Patients will be taken 2 tablets per day of 600 mg film-coated of Linezolid (ZYVOXID®) in the morning for 7 days. Then, the early bactericidal activity will be measured and compared to the other arms. Receives: Drug: Linezolid arm (ZYVOXID®) |
| Standard quadruple therapy arm | Active comparator | Patients will be taken :
ISONIAZIDE :
o A dosage of 3 to 5mg / kg / day for 7 days (to be taken in the morning on an empty stomach) of Isoniazid (RIMIFON®)
RIFAMPICINE :
o A dosage of 10mg / kg / day for 7 days (to be taken in the morning on an empty stomach)
ETHAMBUTOL :
o A dosage of 15-20mg / kg / day for 7 days (to be taken in the morning on an empty stomach) of Ethambutol
PYRAZAMIDE :
o A dosage of 20-25mg / kg / day for 7 days (to be taken in the morning on an empty stomach) of Pyrazinamide
Then, the early bactericidal activity will be measured and compared to the other arms. Receives: Drug: Standard quadruple therapy arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 3
Secondary outcomes (15)
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
Measured: Day 8
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
Measured: Day 3
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
Measured: Day 8
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
Measured: Day 3
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
Measured: Day 8
Tedizolid pharmacokinetics'measurement
To measure the total and free concentration of tedizolid measured at 0, 1, 3, 5 and 24hours
Measured: 24hours
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
Measured: 30 days
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
Measured: 30 days
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
Measured: 30 days
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
Measured: 30 days
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
Measured: 30 days
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
Measured: 30 days
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.
Measured: 30 days
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
Measured: 30 days
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start20 Apr 2023
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas VEZIRIS, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534750
- Sponsor's protocol ID
- APHP210084
- Acronym
- TEDITUB
- Status last verified
- Jan 2025
- First submitted
- 22 Jul 2022
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis
- ClinicalTrials.gov ID
- NCT05534750
- Acronym / sponsor ID
- TEDITUB / APHP210084
- Conditions
- Tuberculosis, Multidrug Resistant Tuberculosis
- Keywords
- Tuberculosis, Multidrug Resistant, Linezolid, Tedizolid, Pyrazinamide, Rifampicin, Isionazid, Ethambutol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 9 Sep 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 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).
Detailed description
This is a Phase 2, prospective, randomized, open-label controlled trial in 3 parallel groups comparing tedizolid with 2 standard treatments: linezolid (oxazolidinone whose anti-tuberculosis activity has already been demonstrated) and standard treatment for tuberculosis (quadruple therapy: isoniazid, rifampicin, ethambutol, pyrazinamide ). The objective is to measure the early bactericidal activity of tedizolid, to compare it with the bactericidal activity of linezolid and with that of standard quadruple therapy.
Design: A multicentric, open-label, randomized clinical trial
Sample size : 60 patients, 20 in each group
Treatments groups:
- Tedizolid arm:
- Tedizolid (SIVEXTRO®),
- 200 mg film-coated tablet
- Dosage of 1 tablet per day to be taken in the morning for 7 days (taken with or without meals).
- Linezolid arm (ZYVOXID®):
- Linezolid arm (ZYVOXID®)
- 600 mg film-coated tablet
- Dosage of 2 tablets per day to be taken in the morning for 7 days (taken with or without meals).
- Standard quadruple therapy arm:
- Isoniazid (RIMIFON®) Tablets 50 or 200 mg Dosage 3 to 5mg / kg / day for 7 days to be taken in the morning on an empty stomach.
- Rifampicin, dosage 10mg / kg / day for 7 days to be taken in the morning on an empty stomach.
- Ethambutol 15-20mg / kg / day for 7 days to be taken in the morning on an empty stomach.
- Pyrazinamide 20-25mg / kg / day for 7 days to be taken in the morning on an empty stomach.
Treatment duration : 7 days
Assessement:
After signing the consent, patients will be randomized, a sputum sample will be taken before the first drug intake. Then, patients will be treated for 7 days depending on the randomization group (tedizolid, linezolid or standard quadruple therapy). Daily, a sputum of at least 2 mL will be withdrawn from the patients for 7 days.
A consultation with blood test will be carried out on D30, date of the patient's end of participation.
No interim analysis is planned. Analysis will be performed at the end of the study after data review and freezing of database.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tedizolid arm | Experimental | Drug: Tedizolid arm (SIVEXTRO®)Patients will be taken 1 tablet per day of 200 mg film-coated of Tedizolid (SIVEXTRO®), in the morning for 7 days. Then, the early bactericidal activity will be measured and compared to the other arms. |
| Linezolid arm | Experimental | Drug: Linezolid arm (ZYVOXID®)Patients will be taken 2 tablets per day of 600 mg film-coated of Linezolid (ZYVOXID®) in the morning for 7 days. Then, the early bactericidal activity will be measured and compared to the other arms. |
| Standard quadruple therapy arm | Active comparator | Drug: Standard quadruple therapy armPatients will be taken : ISONIAZIDE : o A dosage of 3 to 5mg / kg / day for 7 days (to be taken in the morning on an empty stomach) of Isoniazid (RIMIFON®) RIFAMPICINE : o A dosage of 10mg / kg / day for 7 days (to be taken in the morning on an empty stomach) ETHAMBUTOL : o A dosage of 15-20mg / kg / day for 7 days (to be taken in the morning on an empty stomach) of Ethambutol PYRAZAMIDE : o A dosage of 20-25mg / kg / day for 7 days (to be taken in the morning on an empty stomach) of Pyrazinamide Then, the early bactericidal activity will be measured and compared to the other arms. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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),
Key exclusion criteria (20 listed)
- 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 (patients with a documented negative genotypic test for isoniazid and rifampicin resistance may be included)
- 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);
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 |
|---|---|---|
| Tedizolid arm (SIVEXTRO®)Patients will be taken 1 tablet per day of 200 mg film-coated of Tedizolid (SIVEXTRO®), in the morning for 7 days. Then, the early bactericidal activity will be measured and compared to the other arms. | Drug | Tedizolid arm |
| Linezolid arm (ZYVOXID®)Patients will be taken 2 tablets per day of 600 mg film-coated of Linezolid (ZYVOXID®) in the morning for 7 days. Then, the early bactericidal activity will be measured and compared to the other arms. | Drug | Linezolid arm |
| Standard quadruple therapy armPatients will be taken : ISONIAZIDE : o A dosage of 5mg / kg / day for 7 days (to be taken in the morning on an empty stomach) of Isoniazid (RIMIFON®) RIFAMPICINE : o A dosage of 10mg / kg / day for 7 days (to be taken in the morning on an empty stomach) ETHAMBUTOL : o A dosage of 15-20mg / kg / day for 7 days (to be taken in the morning on an empty stomach) of Ethambutol PYRAZAMIDE : o A dosage of 20-25mg / kg / day for 7 days (to be taken in the morning on an empty stomach) of Pyrazinamide Then, the early bactericidal activity will be measured and compared to the other arms. | Drug | Standard quadruple therapy arm |
Primary outcome
Assessment of the early bactericidal activity (EBA) of tedizolid (200mg / day) at the end of the first 2 days of treatment (D3).
Time frame: Day 3
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.
15 secondary outcomes
Evaluation of the early bactericidal activity (EBA) of tedizolid between Day 3 and Day 8
Time frame: Day 8
Comparison of the early bactericidal activity (EBA) of tedizolid between Day 1 and Day 3
Time frame: Day 3
Comparison of the early bactericidal activity (EBA) of tedizolid between Day 3 and Day 8
Time frame: Day 8
Comparison of the early bactericidal activity of tedizolid 200 mg / day to that of standard quadruple therapy between Day 1 and Day 3
Time frame: Day 3
Comparison of the early bactericidal activity of tedizolid 200 mg / day to that of standard quadruple therapy between Day 3 and Day 8
Time frame: Day 8
Tedizolid pharmacokinetics'measurement
Time frame: 24hours
Evaluation of Tedizolid's tolerance on hemoglobin
Time frame: 30 days
Evaluation of Tedizolid's tolerance on polynuclear neutrophils
Time frame: 30 days
Evaluation of Tedizolid's tolerance on platelets
Time frame: 30 days
Evaluation of Tedizolid's tolerance on creatinine clearance
Time frame: 30 days
Evaluation of Tedizolid's tolerance on AST/ALT
Time frame: 30 days
Evaluation of Tedizolid's tolerance on bilirubin
Time frame: 30 days
Evaluation of Tedizolid's tolerance on dress syndrome
Time frame: 30 days
Evaluation of Tedizolid's tolerance on optic neuropathy
Time frame: 30 days
Evaluation of Tedizolid's tolerance on peripheral neuropathy
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Nicolas VEZIRIS, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tedizolid arm (SIVEXTRO®), Linezolid arm (ZYVOXID®) and Standard quadruple therapy arm in people with Tuberculosis and Multidrug Resistant Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas VEZIRIS, PU-PH (01 49 28 30 41, nicolas.veziris@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the early bactericidal activity (EBA) of tedizolid (200mg / day) at the end of the first 2 days of treatment (D3). (time frame: Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2025.