MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00495339

Purpose

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	Intervention	Phase
Tuberculosis, Pulmonary	Drug: Levofloxacin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy 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)

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Number of patients with bacterioexcretion [ Time Frame: 1 month, 2 months, 3 months ] [ Designated as safety issue: No ]
Dynamics of chest radiograph [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Dynamics of Intoxication [ Time Frame: 1 month, 2 months, 3 months ] [ Designated as safety issue: No ]
All clinical and laboratory adverse events [ Time Frame: from the signature of the Informed Concent Form (ICF) up to the end of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	June 2007
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Levofloxacin	Drug: Levofloxacin 500-1000 mg once a day daily per os with combination of drugs.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495339

Locations

Russian Federation
Sanofi-aventis
Moscow, Russian Federation

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Marina Atarshchikova

Sanofi-Aventis

More Information

Additional Information:

Clinicalstudyresult.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	LEVOF_L_00972
Study First Received:	July 2, 2007
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00495339 History of Changes
Health Authority:	Russia: Ministry of Health and Social Development of the Russian Federation

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Tuberculosis, Multidrug-Resistant
Ofloxacin
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Renal Agents
Pharmacologic Actions
Actinomycetales Infections

Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Lung Diseases
Tuberculosis, Pulmonary
Mycobacterium Infections
Tuberculosis
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010