TB-CHAMP
Trial question
What is the role of levofloxacin in children exposed to MDR-TB?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
51.0% female
49.0% male
N = 922
922 patients (468 female, 454 male).
Inclusion criteria: children aged < 5 years with household exposure to MDR-TB.
Key exclusion criteria: tuberculosis at enrolment; myasthenia gravis or Guillain-Barré syndrome; treatment for tuberculosis in the previous 12 months; receipt of isoniazid or fluoroquinolones.
Interventions
N=453 levofloxacin (at an oral dose of 15-20 mg/kg, maximum dose 750 mg, for 24 weeks).
N=469 placebo (matching placebo daily for 24 weeks).
Primary outcome
Rate of incident tuberculosis by week 48
1.1%
2.6%
2.6 %
2.0 %
1.3 %
0.7 %
0.0 %
Levofloxacin
Placebo
No significant
difference ↔
No significant difference in the rate of incident tuberculosis by week 48 (1.1% vs. 2.6%; HR 0.44, 95% CI 0.15 to 1.25).
Secondary outcomes
No significant difference in the rate of incident tuberculosis by week 72 (1.3% vs. 2.8%; HR 0.49, 95% CI 0.18 to 1.3).
No significant difference in the rate of grade ≥ 3 adverse events occurred up to 30 days after the last dose of study drug (3.1% vs. 5.1%; HR 0.64, 95% CI 0.32 to 1.28).
No significant difference in serious adverse events (2% vs. 1.7%; HR 1.22, 95% CI 0.45 to 3.34).
Safety outcomes
No significant difference in grade ≥ 3 adverse events.
Conclusion
In children aged < 5 years with household exposure to MDR-TB, levofloxacin was not superior to placebo with respect to the rate of incident tuberculosis by week 48.
Reference
Anneke C Hesseling, Susan E Purchase, Neil A Martinson et al. Levofloxacin Preventive Treatment in Children Exposed to MDR Tuberculosis. N Engl J Med. 2024 Dec 19;391(24):2315-2326.
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