Evidence map›Paper›PMID 32217561›Full record

ArticleBMJ open2020

Accuracy and consequences of using

Titus Henry Divala, Katherine L Fielding, Derek J Sloan, Neil French, Marriott Nliwasa, Peter MacPherson, Chikondi Charity Kandulu, Lingstone Chiume, Sanderson Chilanga, Masiye John Ndaferankhande and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03545373 (Randomised Controlled Clinical Trial Investigating Benefits of Using Response to Broad Spectrum Antibiotics as an Exclusion Diagnostic for Tuberculosis), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 39% 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.

NCT03545373 phase3completednot on this map

Randomised Controlled Clinical Trial Investigating Benefits of Using Response to Broad Spectrum Antibiotics as an Exclusion Diagnostic for Tuberculosis (TB) in Primary Care Adult Patients Versus Risk of Antimicrobial Resistance (AMR)

TypeinterventionalSponsorLondon School of Hygiene and Tropical MedicineRan2019 to 2020Enrolled1,583ConditionsTuberculosis, Respiratory Tract Infections, PneumoniaArmsAzithromycin, Amoxicillin
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Trial
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 at 4 institutions in 3 countries.

Titus Henry DivalaTB Centre, London School of Hygiene and Tropical Medicine, London, UK titus.divala@lshtm.ac.uk.ORCID 0000-0003-3029-9579
Katherine L FieldingTB Centre, London School of Hygiene and Tropical Medicine, London, UK.
Derek J SloanSchool of Medicine, University of Saint Andrews, Saint Andrews, Fife, UK.
Neil FrenchInstitute of Infection and Global Health, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.
Marriott NliwasaTB Centre, London School of Hygiene and Tropical Medicine, London, UK.
Peter MacPhersonMalawi-Liverpool Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.
Chikondi Charity KanduluHelse Nord Tuberculosis Initiative, University of Malawi College of Medicine, Blantyre, Malawi.
Lingstone ChiumeHelse Nord Tuberculosis Initiative, University of Malawi College of Medicine, Blantyre, Malawi.
Sanderson ChilangaHelse Nord Tuberculosis Initiative, University of Malawi College of Medicine, Blantyre, Malawi.
Masiye John NdaferankhandeMalawi-Liverpool Wellcome Trust Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi.
Elizabeth L CorbettTB Centre, London School of Hygiene and Tropical Medicine, London, UK.
University of Liverpool · GBUniversity of Malawi · MWUniversity of St Andrews · GBUniversity of the Witwatersrand · ZA

Funding

Medical Research Council MR/R010161/1Wellcome Trust 200901/Z/16/ZWellcome Trust 206575/Z/17/ZWellcome Trust WT200901
6 · The paper itself

Abstract

introductionOver 40% of global tuberculosis case notifications are diagnosed clinically without mycobacteriological confirmation. Standard diagnostic algorithms include 'trial-of-antibiotics'-empirical antibiotic treatment given to mycobacteriology-negative individuals to treat infectious causes of symptoms other than tuberculosis, as a 'rule-out' diagnostic test for tuberculosis. Potentially 26.5 million such antibiotic courses/year are prescribed globally for the 5.3 million/year mycobacteriology-negative patients, making trial-of-antibiotics the most common tuberculosis diagnostic, and a global-scale risk for antimicrobial resistance (AMR). Our systematic review found no randomised controlled trial (RCT) to support use of trial-of-antibiotic. The RCT aims to determine the diagnostic and clinical value and AMR consequences of trial-of-antibiotics. METHODS AND ANALYSIS: A three-arm, open-label, RCT randomising (1:1:1) Malawian adults (≥18 years) seeking primary care for cough into: (a) azithromycin 500 mg one time per day for 3 days or (b) amoxicillin 1 g three times per day for 5 days or (c) standard-of-care (no immediate antibiotic). We will perform mycobacteriology tests (microscopy, Xpert MTB/RIF ( ETHICS AND DISSEMINATION: The study has been reviewed and approved by Malawi College of Medicine Research and Ethics Committee, London School of Hygiene & Tropical Medicine (LSHTM) Research Ethics Committee and Regional Committee for Health and Research Ethics - Norway, and Malawi Pharmacy, Medicines and Poisons Board. We will present abstracts at relevant conferences, and prepare a manuscript for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: The clinical trial is registered with ClinicalTrials.gov, NCT03545373.

Indexed as

AmoxicillinAnti-Bacterial AgentsAzithromycinMycobacterium tuberculosisTuberculosisDrug Resistance, BacterialHumansMalawiRandomized Controlled Trials as TopicSensitivity and SpecificityStreptococcus pneumoniaeAmoxicillinAnti-Bacterial AgentsAzithromycinantibioticsantimicrobial resistancediagnostic performanceTBtrial-of-antibioticstuberculosis

Identifiers

PMID32217561
PMCPMC7170647
OpenAlexW3013114706

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.