Factors Predictive of Early Discontinuation of Preventive Treatment in Children With Household Exposure to Multidrug-resistant Tuberculosis
Abstract
Abstract Background The World Health Organization recommended levofloxacin for tuberculosis (TB) preventive treatment for child and adult contacts of multidrug-resistant TB. Method TB-CHAMP (ISRCTN92634082) was a double-blind community-based multisite randomized placebo-controlled trial assessing levofloxacin as preventive treatment in children with household exposure to adults with microbiologically confirmed multidrug-resistant TB in South Africa. Households were randomized 1:1 to 24 weeks of daily levofloxacin (adult scored 250-mg tablets) versus placebo. Treatment adherence was ascertained through pill counts and treatment cards. Competing risk methods were used to assess factors associated with early treatment discontinuation for nonclinical reasons before achieving ≥80% of allocated doses (adequate treatment). Results Among 911 of 922 children included in analysis, 90% were younger than 5 years of age. Overall, 765 (84%) of children achieved adequate treatment, 135 (15%) discontinued treatment early, and 11 (1%) had not achieved adequate treatment by the end-of-treatment period. Sixty-four (7%) children stopped for clinical reasons and 71 (8%) for nonclinical reasons, with similar proportions across treatment groups. Baseline factors associated with early treatment discontinuation for nonclinical reasons were previous receipt of herbal/traditional medicine (subhazard ratio 3.08; 95% confidence interval, 1.69–5.59; P < .001), and caregivers reporting difficulties…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 911 participants or records.
Read the paper
Related studies
- Ferulic acid regulates the AKT/GSK-3β/CRMP-2 signaling pathway in a middle cerebral artery occlusion animal model
- Novel Pharmacokinetic/Pharmacodynamic Parameters Quantify the Exposure–Effect Relationship of Levofloxacin against Fluoroquinolone-Resistant Escherichia coli
- Photochemical behavior of levofloxacin
- Correlation Between Dissolution Profiles of Salt-Form Drugs in Biorelevant Bicarbonate Buffer and Oral Drug Absorption: Importance of Dose/ Fluid Volume Ratio
- Evaluation of the synergistic potential and mechanisms of action for de novo designed cationic antimicrobial peptides
- Synthesis of [11C]levofloxacin
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.