Evidence map›Paper›PMID 33478428›Full record

Trial reportBMC infectious diseases2021

An open label, randomised controlled trial of rifapentine versus rifampicin based short course regimens for the treatment of latent tuberculosis in England: the HALT LTBI pilot study.

J Surey, H R Stagg, T A Yates, M Lipman, P J White, A Charlett, L Muñoz, L Gosce, M X Rangaka, M Francis and 3 more

Open access · goldAbstract readEquivalence TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 27% of its field
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

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Article
  4. Article
  5. Review
  6. The Biological and Clinical Aspects of a Latent Tuberculosis Infection.Tropical medicine and infectious disease · 2022
    Review
  7. Review
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

13 authors at 7 institutions in 2 countries.

J SureyInstitute for Global Health, University College London, London, UK. j.surey@ucl.ac.uk.ORCID http://orcid.org/0000-0003-2411-0477
H R StaggUsher Institute, University of Edinburgh, Edinburgh, UK.
T A YatesInstitute for Global Health, University College London, London, UK.
M LipmanUCL-TB and UCL Respiratory, UCL, London, Royal Free London National Health Service Foundation Trust, London, UK.
P J WhiteNational Infection Service, Public Health, England, UK.
A CharlettNational Infection Service, Public Health, England, UK.
L MuñozClinical Sciences Department. School of Medicine, University of Barcelona and Internal Medicine Department, Parc Sanitari Sant Joan de Déu. Sant Boi, Barcelona, Spain.
L GosceInstitute for Global Health, University College London, London, UK.
M X RangakaInstitute for Global Health, University College London, London, UK.
M FrancisInstitute for Global Health, University College London, London, UK.
V HackInstitute for Global Health, University College London, London, UK.
H KunstBlizard Institute, Queen Mary University of London, London, UK.
I AbubakarInstitute for Global Health, University College London, London, UK.
University College London · GBPublic Health England · GBNational Health Service · GBParc Sanitari Sant Joan de Déu · ESQueen Mary University of London · GBThe George Institute for Global Health · GBUniversity of Edinburgh · GB

Funding

Department of Health PB-PG-0317-20039Department of Health RP-PG-0217-20009Medical Research Council MR/K010174/1Medical Research Council MR/R008345/1Medical Research Council MR/R015600/1
6 · The paper itself

Abstract

backgroundEnding the global tuberculosis (TB) epidemic requires a focus on treating individuals with latent TB infection (LTBI) to prevent future cases. Promising trials of shorter regimens have shown them to be effective as preventative TB treatment, however there is a paucity of data on self-administered treatment completion rates. This pilot trial assessed treatment completion, adherence, safety and the feasibility of treating LTBI in the UK using a weekly rifapentine and isoniazid regimen versus daily rifampicin and isoniazid, both self-administered for 12 weeks.

methodsAn open label, randomised, multi-site pilot trial was conducted in London, UK, between March 2015 and January 2017. Adults between 16 and 65 years with LTBI at two TB clinics who were eligible for and agreed to preventative therapy were consented and randomised 1:1 to receive either a weekly combination of rifapentine/isoniazid ('intervention') or a daily combination of rifampicin/isoniazid ('standard'), with both regimens taken for twelve weeks; treatment was self-administered in both arms. The primary outcome, completion of treatment, was self-reported, defined as taking more than 90% of prescribed doses and corroborated by pill counts and urine testing. Adverse events were recorded.

resultsFifty-two patients were successfully enrolled. In the intervention arm 21 of 27 patients completed treatment (77.8, 95% confidence interval [CI] 57.7-91.4), compared with 19 of 25 (76.0%, CI 54.9-90.6) in the standard of care arm. There was a similar adverse effect profile between the two arms.

conclusionIn this pilot trial, treatment completion was comparable between the weekly rifapentine/isoniazid and the daily rifampicin/isoniazid regimens. Additionally, the adverse event profile was similar between the two arms. We conclude that it is safe and feasible to undertake a fully powered trial to determine whether self-administered weekly treatment is superior/non-inferior compared to current treatment.

trial registrationThe trial was funded by the NIHR, UK and registered with ISRCTN ( 26/02/2013-No.04379941 ).

Indexed as

AdolescentAdultAntitubercular AgentsDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansIsoniazidLatent TuberculosisLondonMaleMiddle AgedPilot ProjectsRifampinSelf AdministrationTreatment OutcomeAntitubercular AgentsIsoniazidRifampinrifapentineLatent tuberculosis treatmentRandomised controlled trialRifapentineTuberculosis

Identifiers

PMID33478428
PMCPMC7818935
OpenAlexW3109727811

What OpenQuestion 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 OpenQuestion graph.