Evidence map›Paper›PMID 40821683›Full record

ArticleIJTLD open2025

Acceptability of a clofazimine tablet in children with rifampicin-resistant TB in three high-burden countries.

L Viljoen, H R Draper, N T Castillo-Carandang, N Suryavanshi, A Marthinus, A M A Cheong, J D D Ocampo, G Dhumal, S Bagchi, D T Wademan and 8 more

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

18 authors.

L ViljoenDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
H R DraperDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
N T Castillo-CarandangDepartment of Clinical Epidemiology, College of Medicine, University of the Philippines Manila, Philippines.
N SuryavanshiProgram on Social Innovation in Health, National Institutes of Health, University of the Philippines Manila, Philippines.
A MarthinusDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
A M A CheongDe La Salle Health Sciences Institute, Dasmariñas City, Cavite, the Philippines.
J D D OcampoProgram on Social Innovation in Health, National Institutes of Health, University of the Philippines Manila, Philippines.
G DhumalByramjee Jeejeebhoy Government Medical College -Johns Hopkins Clinical Research Site, Pune, India.
S BagchiByramjee Jeejeebhoy Government Medical College -Johns Hopkins Clinical Research Site, Pune, India.
D T WademanDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
A KinikarDepartment of Paediatrics, Byramjee Jeejeebhoy Government Medical College, Pune, India.
M ParadkarByramjee Jeejeebhoy Government Medical College -Johns Hopkins Clinical Research Site, Pune, India.
M V G FriasDe La Salle Health Sciences Institute, Dasmariñas City, Cavite, the Philippines.
D J O CasalmeDe La Salle Health Sciences Institute, Dasmariñas City, Cavite, the Philippines.
A C HesselingDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
A J Garcia-PratsDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
M PalmerDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
G HoddinottDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRifampicin-resistant TB (RR-TB) in children is frequently treated with clofazimine (CFZ), widely available as a 100mg gel capsule. This formulation is challenging to administer and is poorly acceptable to children and caregivers. Poor acceptability may negatively impact adherence and treatment outcomes. We describe the acceptability of a novel 50mg CFZ tablet formulation among children in South Africa, India, and the Philippines.

methodsMixed methods assessments were completed in a moxifloxacin and CFZ safety and pharmacokinetics trial in children with RR-TB. Quantitative data were collected from 36 participants at 4 timepoints. A sub-sample of 26 child/caregiver dyads participated in ∼4 qualitative interviews. Descriptive statistics and thematic analysis were employed.

findingsThe median age of n=36 participants (South Africa n=20; India n=6; the Philippines n=10) was 4.9 years. The majority (29/36) received a CFZ gel capsule prior to switching to the tablet formulation. The 50mg tablet had better acceptability scores for taste (p=0.035), smell (p=0.035), and ease of swallowing (p=0.02) compared to gel capsules. Participants described the tablet formulation as easier to administer/take without a lingering smell or taste. Limited concerns were noted on staining.

conclusionThe novel 50mg CFZ tablet has better acceptability and should be prioritised for children wherever possible.

Indexed as

dispersible tabletsdrug-resistant TBIndiaPhilippinesSouth Africatuberculosis

Identifiers

PMID40821683
PMCPMC12352948

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 Socratic graph.