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Completed

NCT Number: NCT00495339

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

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.

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Key information

Conditions

Tuberculosis, Pulmonary Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Moscow, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levofloxacin

Drug

500-1000 mg once a day daily per os with combination of drugs.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2008
First posted
Jul 3, 2007
Registry last updated
Mar 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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