VQUIN MDR
Trial question
What is the role of levofloxacin for the prevention of MDR-TB?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
64.0% female
36.0% male
N = 2041
2041 patients (1306 female, 735 male).
Inclusion criteria: household contacts of persons with bacteriologically confirmed rifampicin-resistant or MDR-TB.
Key exclusion criteria: no informed consent; usual residence outside of the provinces participating in the study.
Interventions
N=1023 levofloxacin (maximum daily oral dose of 750 mg for 180 days).
N=1018 placebo (matching placebo tablets for 180 days).
Primary outcome
Rate of bacteriologically confirmed tuberculosis within 30 months
0.6%
1.1%
1.1 %
0.8 %
0.6 %
0.3 %
0.0 %
Levofloxacin
Placebo
No significant
difference ↔
No significant difference in the rate of bacteriologically confirmed tuberculosis within 30 months (0.6% vs. 1.1%; IRR 0.55, 95% CI 0.19 to 1.62).
Secondary outcomes
No significant difference in grade 3 or 4 adverse events (3% vs. 2%; AD 1%, 95% CI -0.3 to 2.4).
No significant difference in deaths after treatment (0.4% vs. 0.3%; AD 0.1%, 95% CI -0.4 to 0.6).
No significant difference in the incidence of bacteriologically confirmed or clinically diagnosed tuberculosis (0.271/100 py vs. 0.507/100 py; IRR 0.54, 95% CI 0.2 to 1.46).
Safety outcomes
No significant difference in grade 1 or 2 adverse events.
Significant difference in adverse events of any grade (31.9% vs. 13.0%).
Conclusion
In household contacts of persons with bacteriologically confirmed rifampicin-resistant or MDR-TB, levofloxacin was not superior to placebo with respect to the rate of bacteriologically confirmed tuberculosis within 30 months.
Reference
Greg J Fox, Nguyen Viet Nhung, Nguyen Cam Binh et al. Levofloxacin for the Prevention of Multidrug-Resistant Tuberculosis in Vietnam. N Engl J Med. 2024 Dec 19;391(24):2304-2314.
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