Duong, Trinh;
Brigden, Joanna;
Purchase, Susan E;
Martinson, Neil A;
Fairlie, Lee;
Staples, Suzanne;
Patel, Faeezah;
... TB-CHAMP team; + view all
(2025)
Factors Predictive of Early Discontinuation of Preventive Treatment in Children With Household Exposure to Multidrug-resistant Tuberculosis.
Open Forum Infectious Diseases
, 12
(8)
, Article ofaf425. 10.1093/ofid/ofaf425.
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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 administering medication (subhazard ratio 2.73; 1.11–6.71; P = .029). Children with poor treatment adherence by week 4 were more likely to subsequently stop treatment early for nonclinical reasons (subhazard ratio 2.72; 1.06–6.97; P = .037). / Conclusions: Adherence to the 250-mg levofloxacin formulation was good among young children on preventive TB therapy. Adherence support for children and caregivers, and addressing early signs of poor adherence, may enhance treatment completion.
| Type: | Article |
|---|---|
| Title: | Factors Predictive of Early Discontinuation of Preventive Treatment in Children With Household Exposure to Multidrug-resistant Tuberculosis |
| Location: | United States |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1093/ofid/ofaf425 |
| Publisher version: | https://doi.org/10.1093/ofid/ofaf425 |
| Language: | English |
| Additional information: | Copyright © The Author(s) 2025. Published by Oxford University Press on behalf of Infectious Diseases Society of America. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
| Keywords: | adherence, children, levofloxacin, multidrug-resistant tuberculosis, preventive treatment |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10213986 |
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