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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00495339
First received: July 2, 2007
Last updated: March 3, 2009
Last verified: June 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

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
Experimental: 1
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

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

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
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on July 22, 2014