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MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00495339
Recruitment Status : Completed
First Posted : July 3, 2007
Last Update Posted : March 4, 2009
Sponsor:
Information provided by:
Sanofi

Brief 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.


Condition or disease Intervention/treatment Phase
Tuberculosis, Pulmonary Drug: Levofloxacin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : June 2007
Actual Primary Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: 1
Levofloxacin
Drug: Levofloxacin
500-1000 mg once a day daily per os with combination of drugs.




Primary Outcome Measures :
  1. Number of patients with bacterioexcretion [ Time Frame: 1 month, 2 months, 3 months ]
  2. Dynamics of chest radiograph [ Time Frame: 3 months ]
  3. Dynamics of Intoxication [ Time Frame: 1 month, 2 months, 3 months ]
  4. All clinical and laboratory adverse events [ Time Frame: from the signature of the Informed Concent Form (ICF) up to the end of the study ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Drug-resistant pulmonary tuberculosis laboratory diagnosed

Exclusion Criteria:

  • 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
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495339


Locations
Russian Federation
Sanofi-Aventis
Moscow, Russian Federation
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Marina Atarshchikova Sanofi

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00495339     History of Changes
Other Study ID Numbers: LEVOF_L_00972
First Posted: July 3, 2007    Key Record Dates
Last Update Posted: March 4, 2009
Last Verified: June 2008

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Tuberculosis, Multidrug-Resistant
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors