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Acceptability of a 250 mg levofloxacin formulation in children receiving TB preventive treatment

S E Purchase1, J Brigden2, J A Seddon1,3

  • 1Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa.

IJTLD Open
|March 17, 2025
PubMed

Insights

Levofloxacin (LFX) is effective for preventing multidrug-resistant tuberculosis (MDR-TB) in children. The 250 mg adult LFX tablet showed reasonable acceptability, particularly in children who could swallow pills whole or halved.

Area of Science:

  • Pediatric infectious diseases
  • Tuberculosis prevention
  • Pharmacology

Background:

  • Levofloxacin (LFX) demonstrates efficacy in preventing multidrug-resistant tuberculosis (MDR-TB) among exposed individuals.
  • Pediatric formulations are needed, but the adult 250 mg LFX tablet is accessible and used for TB prevention in children.

Purpose of the Study:

  • To evaluate the acceptability of the adult 250 mg levofloxacin (LFX) tablet for multidrug-resistant tuberculosis (MDR-TB) preventive therapy in children.
  • To compare the acceptability of LFX to placebo in the TB-CHAMP trial.

Main Methods:

  • The TB-CHAMP trial randomized 922 children exposed to MDR-TB to receive either levofloxacin (LFX) or placebo for 24 weeks.
  • Caregiver questionnaires assessed acceptability using Likert scales across six domains, generating a composite acceptability (CA) score.
  • Modified Poisson regression analyzed factors associated with acceptability, calculating risk ratios (RRs).

Main Results:

  • At Week 8, 25.1% of children on LFX had poor composite acceptability (CA) versus 6.2% on placebo (RR 3.43).
  • Acceptability improved in the LFX arm, with poor CA decreasing from 36.8% at baseline to 12.9% at Week 24.
  • Children swallowing tablets whole/halved had significantly better acceptability (11.7% poor CA) compared to those swallowing crushed/softened tablets (34.4% poor CA) at Week 8.

Conclusions:

  • The 250 mg levofloxacin (LFX) tablet exhibits reasonable acceptability for MDR-TB preventive therapy in children.
  • LFX 250 mg tablets can serve as a viable alternative to dispersible formulations, especially for pediatric populations capable of swallowing whole or halved tablets.
Abstract

Keywords:
multidrug-resistant tuberculosispaediatricsprevention

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