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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tuberculosis, Pulmonary

Intervention: Levofloxacin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Marina Atarshchikova, Study Director, Affiliation: Sanofi

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of patients with bacterioexcretion

Dynamics of chest radiograph

Dynamics of Intoxication

All clinical and laboratory adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Sanofi-Aventis, Moscow, Russian Federation
Additional Information

Starting date: June 2007
Last updated: March 3, 2009

Page last updated: August 23, 2015

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