Tuberculosis, PulmonaryPhase 4NCT00495339
MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis
A Phase 4 study testing Levofloxacin in people with Tuberculosis, Pulmonary, run by Sanofi at 1 site in Russia.
Trial summary
Estimate of clinical and microbiological efficacy of Levofloxacin (Tavanic) in combine therapy of MDR TB. Estimate of safety of Levofloxacin (Tavanic) in combine therapy of MDR TB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- Levofloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- Jun 2007to Apr 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Drug-resistant pulmonary tuberculosis laboratory diagnosed
Who cannot join
- Known hypersensitivity to levofloxacin, other quinolones
- Patient with epilepsy and central nervous system diseases
- Renal insufficiency with serum creatinine lower than 50 ml/min
- Arterial hypertension, ischemic heart disease in acute phase
- Gastro-intestinal diseases, liver diseases in acute phase
- History of drug and alcohol abuse
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- Patient with history of tendon disorders related to fluoroquinolone administration
- Pregnancy and breast-feeding women
- Immune system disorders related to chemotherapy, AIDS, long term administration of corticosteroids
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Open Non-Comparative Clinical Study to Evaluate the Efficacy and Safety of Three Months TAVANIC Course (Levofloxacin) in Combine Treatment of Multi-Drug-Resistant Tuberculosis (MDR-TB)
Estimate of clinical and microbiological efficacy of Levofloxacin (Tavanic) in combine therapy of MDR TB.
Estimate of safety of Levofloxacin (Tavanic) in combine therapy of MDR TB.
- Conditions
- Tuberculosis, Pulmonary
- Being tested
- Levofloxacin
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
500-1000 mg once a day daily per os with combination of drugs.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Levofloxacin Receives: Drug: Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with bacterioexcretion
Measured: 1 month, 2 months, 3 months
Dynamics of chest radiograph
Measured: 3 months
Dynamics of Intoxication
Measured: 1 month, 2 months, 3 months
All clinical and laboratory adverse events
Measured: from the signature of the Informed Concent Form (ICF) up to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marina Atarshchikova, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495339
- Sponsor's protocol ID
- LEVOF_L_00972
- Status last verified
- Jun 2008
- First submitted
- 2 Jul 2007
- Last updated
- 4 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Open Non-Comparative Clinical Study to Evaluate the Efficacy and Safety of Three Months TAVANIC Course (Levofloxacin) in Combine Treatment of Multi-Drug-Resistant Tuberculosis (MDR-TB)
- ClinicalTrials.gov ID
- NCT00495339
- Acronym / sponsor ID
- LEVOF_L_00972
- Conditions
- Tuberculosis, Pulmonary
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Apr 2008 (actual)
- First posted
- 3 Jul 2007 (estimated)
- 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.
Estimate of clinical and microbiological efficacy of Levofloxacin (Tavanic) in combine therapy of MDR TB.
Estimate of safety of Levofloxacin (Tavanic) in combine therapy of MDR TB.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: LevofloxacinLevofloxacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Drug-resistant pulmonary tuberculosis laboratory diagnosed
Key exclusion criteria (10 listed)
- Known hypersensitivity to levofloxacin, other quinolones
- Patient with epilepsy and central nervous system diseases
- Renal insufficiency with serum creatinine lower than 50 ml/min
- Arterial hypertension, ischemic heart disease in acute phase
- Gastro-intestinal diseases, liver diseases in acute phase
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 |
|---|---|---|
| Levofloxacin500-1000 mg once a day daily per os with combination of drugs. | Drug | 1 |
Primary outcome
Number of patients with bacterioexcretion
Time frame: 1 month, 2 months, 3 months
Dynamics of chest radiograph
Time frame: 3 months
Dynamics of Intoxication
Time frame: 1 month, 2 months, 3 months
All clinical and laboratory adverse events
Time frame: from the signature of the Informed Concent Form (ICF) up to the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2009.
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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. This study is not recruiting at the moment.
Marina Atarshchikova study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levofloxacin in people with Tuberculosis, Pulmonary, run by Sanofi at 1 site in Russia.
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 1 inclusion and 10 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: finished, as of the sponsor's last update on 4 Mar 2009. 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 Russia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with bacterioexcretion (time frame: 1 month, 2 months, 3 months). The study lists 4 primary outcomes in all. 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 4 Mar 2009; AzTrials last refreshed its copy on 7 Nov 2026.