Evidence map›Paper›PMID 40092520›Full record

ArticleIJTLD open2025

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

S E Purchase, J Brigden, J A Seddon, N A Martinson, L Fairlie, S Staples, A Poswa, T Duong, H S Schaaf, A C Hesseling

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in IJTLD open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

S E PurchaseDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa.
J BrigdenInstitute of Clinical Trials and Methodology, MRC Clinical Trials Unit at University College London, London, UK.
J A SeddonDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa.
N A MartinsonPerinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
L FairlieWits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
S StaplesTHINK, Durban, South Africa.
A PoswaIsango Lethemba TB Research Unit, Wits Health Consortium, University of the Witwatersrand, Johannesburg, South Africa.
T DuongInstitute of Clinical Trials and Methodology, MRC Clinical Trials Unit at University College London, London, UK.
H S SchaafDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa.
A C HesselingDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa.

Funding

Wellcome Trust
6 · The paper itself

Abstract

backgroundRecent evidence indicates that levofloxacin (LFX) is effective in preventing TB in individuals exposed to multidrug-resistant TB (MDR-TB). Despite the need for pediatric formulations, the 250 mg adult LFX formulation is affordable and widely used for TB treatment and prevention in children.

methodsTB-CHAMP (Tuberculosis Child Multidrug-resistant Preventive Therapy ISRCTN92634082) was a trial of MDR-TB preventive treatment, comparing levofloxacin to placebo in children with MDR-TB exposure. Acceptability questionnaires were administered to caregivers at six timepoints during the 24-week treatment phase. Likert scales were used to grade 6 domains of acceptability, and a composite acceptability (CA) outcome was generated. Factors associated with acceptability were assessed using modified Poisson regression models to estimate risk ratios (RRs).

resultsOverall, 922 children were randomised, 453 to LFX and 469 to placebo. By Week 8, 25.1% of children on LFX had poor CA versus 6.2% receiving placebo (Weeks 0-24: RR 3.43, 95% CI 2.69-4.37). Acceptability in the LFX arm improved from 36.8% poor CA at baseline to 12.9% at Week 24. Only 11.7% of children swallowing tablets whole/halved had poor CA outcomes at Week 8, compared to 34.4% swallowing crushed/softened tablets.

conclusionLFX 250 mg tablets have reasonable acceptability and could be used as an alternative to dispersible formulations, especially in children able to swallow tablets.

Indexed as

multidrug-resistant tuberculosispaediatricsprevention

Identifiers

PMID40092520
PMCPMC11906031

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.