Evidence map›Paper›PMID 35273049›Full record

ArticleBMJ open2022

Safety and pharmacokinetics-pharmacodynamics of a shorter tuberculosis treatment with high-dose pyrazinamide and rifampicin: a study protocol of a phase II clinical trial (HighShort-RP).

David Ekqvist, Anna Bornefall, Daniel Augustinsson, Martina Sönnerbrandt, Michaela Jonsson Nordvall, Mats Fredrikson, Björn Carlsson, Mårten Sandstedt, Ulrika S H Simonsson, Jan-Willem C Alffenaar and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04694586 (A Prospective Multicenter Phase II-study), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 37% 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.

NCT04694586 phase2suspendednot on this map

A Prospective Multicenter Phase II-study: Pharmacokinetics and Safety of High-Dose Rifampicin and Pyrazinamide in a Shorter Tuberculosis Treatment Compared With Standardized Treatment in Patients With Mild to Moderate Pulmonary TB

TypeinterventionalSponsorUniversity Hospital, LinkoepingRan2022 to 2030Enrolled40ConditionsTuberculosis, PulmonaryArmsrifampicin, pyrazinamide, HRZE, HR
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  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

12 authors at 4 institutions in 2 countries.

David EkqvistDepartment of Infectious Diseases, Region Östergötland, Linköping University, Linköping, Sweden.
Anna BornefallDepartment of Infectious Diseases, Region Östergötland, Linköping, Sweden.
Daniel AugustinssonDepartment of Infectious Diseases, Region Östergötland, Norrköping, Sweden.
Martina SönnerbrandtDepartment of Infectious Diseases, Region Östergötland, Linköping, Sweden.
Michaela Jonsson NordvallDepartment of Clinical Microbiology, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
Mats FredriksonForum Östergötland, Linköping University, Linköping, Sweden.
Björn CarlssonDepartment of Clinical Pharmacology, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
Mårten SandstedtDepartment of Radiology in Linköping, and Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
Ulrika S H SimonssonDepartment of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
Jan-Willem C AlffenaarSchool of Pharmacy, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.
Jakob PauesDepartment of Infectious Diseases, and Department of Biomedical and Clinical Sciences, Linköping University, Linkoping, Sweden.
Katarina NiwardDepartment of Infectious Diseases, and Department of Biomedical and Clinical Sciences, Linköping University, Linkoping, Sweden katarina.niward@liu.se.ORCID 0000-0002-5290-5165
Linköping University · SERegion ÖstergötlandThe University of Sydney · AUUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIncreased dosing of rifampicin and pyrazinamide seems a viable strategy to shorten treatment and prevent relapse of drug-susceptible tuberculosis (TB), but safety and efficacy remains to be confirmed. This clinical trial aims to explore safety and pharmacokinetics-pharmacodynamics of a high-dose pyrazinamide-rifampicin regimen. METHODS AND ANALYSIS: Adult patients with pulmonary TB admitted to six hospitals in Sweden and subjected to receive first-line treatment are included. Patients are randomised (1:3) to either 6-month standardised TB treatment or a 4-month regimen based on high-dose pyrazinamide (40 mg/kg) and rifampicin (35 mg/kg) along with standard doses of isoniazid and ethambutol. Plasma samples for measurement of drug exposure determined by liquid chromatography tandem-mass spectrometry are obtained at 0, 1, 2, 4, 6, 8, 12 and 24 hours, at day 1 and 14. Maximal drug concentration (C ETHICS AND DISSEMINATION: The study is approved by the Swedish Ethical Review Authority and the Swedish Medical Products Agency. Informed written consent is collected before study enrolment. The study results will be submitted to a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04694586.

Indexed as

PyrazinamideTuberculosisAdultAntitubercular AgentsClinical Trials, Phase II as TopicDrug Therapy, CombinationHumansIsoniazidRandomized Controlled Trials as TopicRecurrenceRifampinAntitubercular AgentsIsoniazidPyrazinamideRifampinadverse eventsclinical pharmacologyclinical trialstuberculosis

Identifiers

PMID35273049
PMCPMC8915351
OpenAlexW4221008177

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.