Levofloxacin for Preventing Drug-Resistant Tuberculosis in Vietnam
Background
Preventing drug-resistant tuberculosis is a major global health goal. There have been few studies on how to effectively treat tuberculosis infections in people close to those with drug-resistant tuberculosis.
Methods
We conducted a well-structured clinical trial where participants received either levofloxacin or a placebo for 6 months to treat tuberculosis infection. The study involved household contacts of individuals with confirmed drug-resistant tuberculosis in Vietnam. Anyone with a positive skin test or weakened immune system could join. The main goal was to check for confirmed tuberculosis cases within 30 months. We also looked at severe side effects, deaths, and any drug resistance.
Results
Out of 3948 individuals screened, only 61 (1.5%) had active tuberculosis before randomization. We randomized 2041 participants, with 1995 (97.7%) completing the 30-month follow-up. Tuberculosis was confirmed in 6 participants (0.6%) taking levofloxacin and 11 (1.1%) in the placebo group. This difference was not statistically significant. There was a slight difference in severe side effects between the groups. Adverse events of any kind were reported in 306 participants (31.9%) on levofloxacin compared to 125 (13.0%) on placebo. No new drug resistance was found.
Conclusions
While the levofloxacin group had fewer tuberculosis cases than the placebo group, the difference was not significant. This study was funded by the National Health and Medical Research Council of Australia.
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