Clinical research on the multi drug theray including LVFX against tuberculosis
- Conditions
- lung tuberculosis
- Registration Number
- JPRN-UMIN000008094
- Lead Sponsor
- Ryoken
- Brief Summary
Background: Levofloxacin is used as an antibiotic, while its prospective safety study for the long term use has not been reported. This lack of information is a barrier to its use for the anti-tuberculosis drugs. Method: Cases that used levofloxacin for a long term were prospectively followed up at hospitals that belonged to Ryoken. Proportions of adverse events are reported. Results and discussion: Among 91 cases, 5 cases were reported to have adverse drug reactions that are or may be related to levofloxacin. Among these 5 cases, 4 cases reported arthralgia and muscle pain and these events occurred 490 to 157 days after starting levofloxacin. Life table analysis using Kaplan Mayer method revealed the adverse drug reaction free proportion of 93.5% at 180 days. Among 49 bacillary positive cases, 1 case died one month later, one case was without culture examination and 47 cases showed culture conversion. Conclusion: Levofloxacin is thought to be used safely for a long term but arthralgia needs to be checked for long users.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Not provided
resistant tu LVFX or OFLX patients who are contraindicated to Cravit®
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The efficacy is measured by the proportion of negative conversion of tuberculosis bacilli. The safety is measured by the emergence of side effects (clinical findings and laboratory examination)
- Secondary Outcome Measures
Name Time Method