Evidence map›Paper›PMID 42866592›Full record

ReviewIJTLD open2026

Trials, tribulations, and formulations in access to new TB drugs for children: learning from rifapentine.

A C Hesseling, N Salazar-Austin, M Louey, L van der Laan, M Gombe, T Masini, M Penazzato, I Courtney, A Garcia-Prats, D Tarlton and 1 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in IJTLD open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

11 authors.

A C HesselingDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa.
N Salazar-AustinDepartment of Pediatrics and Johns Hopkins Bloomberg School of Public Health, Department of International Health, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
M LoueyClinton Health Access Initiative, New York, NY, USA.
L van der LaanDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa.
M GombeThe Aurum Institute, Johannesburg, South Africa.
T MasiniIndependent Consultant, Lucca, Italy.
M PenazzatoGlobal Accelerator for Paediatric Formulations Network, World Health Organization, Geneva, Switzerland.
I CourtneyDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa.
A Garcia-PratsDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa.
D TarltonUNITAID, Geneva, Switzerland.
M FrickTreatment Action Group, New York, NY, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Historically, there has been considerable delay between stringent regulatory authority approval for new TB drugs in adults, and subsequent trials, registration, and access for children. This has been due to the exclusion of older children from phase 3 trials, the failure to study novel drugs in younger children earlier on, and delays in developing and testing paediatric formulations. Specific barriers include the failure to develop paediatric investigational plans early on, regulatory barriers, inefficient trial design and implementation, limited site capacity, and lack of advocacy and funding. The successful implementation of paediatric clinical trials depend on timely access to appropriate paediatric formulations. We review the delayed evaluation of rifapentine in children and describe barriers, costs in time and resources, and lost opportunities resulting in delayed clinical trials and access in the field, and highlight avoidable delays. Lessons regarding enablers and inhibitors from the rifapentine experience could prevent similar delays in future.

Indexed as

acceptabilitypaediatricspreventionrifamycinstreatmenttuberculosis

Identifiers

PMID42866592
PMCPMC13657021

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.