Evidence map›Paper›PMID 37370174›Full record

ArticleTrials2023

SMA-TB: study protocol for the phase 2b randomized double-blind, placebo-controlled trial to estimate the potential efficacy and safety of two repurposed drugs, acetylsalicylic acid and ibuprofen, for use as adjunct therapy added to, and compared with, the standard WHO recommended TB regimen.

Lilibeth Arias, Kennedy Otwombe, Ziyaad Waja, Nestani Tukvadze, Tamta Korinteli, Tumelo Moloantoa, Kaori L Fonseca, Natasha Pillay, Thabiso Seiphetlo, Dan Ouchi-Vernet and 6 more

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

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04575519 (Phase 2b Randomized Double-blind, Placebo-controlled Trial to Estimate the Potential Efficacy and Safety of Two Repurposed Drugs, Acetylsalicylic Acid and Ibuprofen, for Use as Adjunct Therapy Added to, and Compared With, the Standard WHO-recommended TB Regimen), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.7field-weighted citation impact, top 16% 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.

NCT04575519 phase2terminatednot on this map

Phase 2b Randomized Double-blind, Placebo-controlled Trial to Estimate the Potential Efficacy and Safety of Two Repurposed Drugs, Acetylsalicylic Acid and Ibuprofen, for Use as Adjunct Therapy Added to, and Compared With, the Standard WHO-recommended TB Regimen (SMA-TB)

TypeinterventionalSponsorFundació Institut Germans Trias i PujolRan2021 to 2024Enrolled426ConditionsTuberculosis, Pulmonary, Tuberculosis, MDR, Tuberculosis InfectionArmsControl group, ASA group, IBU group, SoC TB
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 11 citations in OpenAlex.

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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

16 authors at 6 institutions in 4 countries.

Lilibeth AriasUnitat de Tuberculosi Experimental, Germans Trias I Pujol Research Institute (IGTP), Badalona, Catalonia, Spain.
Kennedy OtwombePerinatal HIV Research Unit (PHRU), University of the Witwatersrand, Johannesburg, South Africa.
Ziyaad WajaPerinatal HIV Research Unit (PHRU), University of the Witwatersrand, Johannesburg, South Africa.
Nestani TukvadzeNational Center for Tuberculosis and Lung Diseases (NCTLD), Tbilisi, Georgia.
Tamta KorinteliNational Center for Tuberculosis and Lung Diseases (NCTLD), Tbilisi, Georgia.
Tumelo MoloantoaPerinatal HIV Research Unit (PHRU), University of the Witwatersrand, Johannesburg, South Africa.
Kaori L FonsecaUnitat de Tuberculosi Experimental, Germans Trias I Pujol Research Institute (IGTP), Badalona, Catalonia, Spain.
Natasha PillayPerinatal HIV Research Unit (PHRU), University of the Witwatersrand, Johannesburg, South Africa.
Thabiso SeiphetloPerinatal HIV Research Unit (PHRU), University of the Witwatersrand, Johannesburg, South Africa.
Dan Ouchi-VernetInstitut d'Investigació en Atenció Primària de Salut Jordi Gol (IDIAPJgol), Barcelona, Spain.
Adrian SilesPharmacy department, Germans Trias I Pujol Hospital and Research Institute (HUGTIP-IGTP), Badalona, Catalonia, Spain.
Lidia CarabiasPharmacy department, Germans Trias I Pujol Hospital and Research Institute (HUGTIP-IGTP), Badalona, Catalonia, Spain.
Carles QuiñonesPharmacy department, Germans Trias I Pujol Hospital and Research Institute (HUGTIP-IGTP), Badalona, Catalonia, Spain.
Sergo Vashakidze *National Center for Tuberculosis and Lung Diseases (NCTLD), Tbilisi, Georgia.
Neil Martinson *Perinatal HIV Research Unit (PHRU), University of the Witwatersrand, Johannesburg, South Africa.
Cristina Vilaplana *Unitat de Tuberculosi Experimental, Germans Trias I Pujol Research Institute (IGTP), Badalona, Catalonia, Spain. cvilaplana@igtp.cat.ORCID http://orcid.org/0000-0002-2808-7270
University of the Witwatersrand · ZACentro de Investigación Biomédica en Red de Enfermedades Respiratorias · ESInstitut d'Investigació en Ciències de la Salut Germans Trias i Pujol · ESNational Center for Tuberculosis and Lung Disease · GEInstitut Universitari d'Investigació en Atenció Primària Jordi Gol · ESJohns Hopkins University · US

Funding

Emory-Georgia TB Research Training ProgramD43TW007124 · FIC · EMORY UNIVERSITY · PI HENRY M BLUMBERG, Nestani Tukvadze · 2004 to 2026
$4.6M
FIC NIH HHS D43 TW007124
6 · The paper itself

Abstract

backgroundThe duration and regimen of tuberculosis (TB) treatment is currently based predominantly on whether the M. tuberculosis (Mtb) strain is drug-sensitive (DS) or multidrug-resistant (MDR) with doses adjusted by patients' weight only. The systematic stratification of patients for personalized treatment does not exist for TB. As each TB case is different, individualized treatment regimens should be applied to obtain better outcomes. In this scenario, novel therapeutic approaches are urgently needed to (1) improve outcomes and (2) shorten treatment duration, and host-directed therapies (HDT) might be the best solution. Within HDT, repurposed drugs represent a shortcut in drug development and can be implemented at the short term. As hyperinflammation is associated with worse outcomes, HDT with an anti-inflammatory effect might improve outcomes by reducing tissue damage and thus the risk of permanent sequelae.

methodsSMA-TB is a multicentre randomized, phase IIB, placebo-controlled, three-arm, double-blinded clinical trial (CT) that has been designed in the context of the EC-funded SMA-TB Project ( www.smatb.eu ) in which we propose to use 2 common non-steroidal anti-inflammatory drugs (NSAID), acetylsalicylic acid (ASA) and ibuprofen (Ibu), as an HDT for use as adjunct therapy added to, and compared with, the standard of care (SoC) World Health Organization (WHO)-recommended TB regimen in TB patients. A total of 354 South African and Georgian adults diagnosed with confirmed pulmonary TB will be randomized into SoC TB treatment + placebo, SoC + acetylsalicylic acid or SoC + ibuprofen. DISCUSSION: SMA-TB will provide proof of concept of the HDT as a co-adjuvant treatment and identify the suitability of the intervention for different population groups (different epidemiological settings and drug susceptibility) in the reduction of tissue damage and risk of bad outcomes for TB patients. This regimen potentially will be more effective and targeted: organ saving, reducing tissue damage and thereby decreasing the length of treatment and sequelae, increasing cure rates and pathogen clearance and decreasing transmission rates. It will result in better clinical practice, care management and increased well-being of TB patients.

trial registrationClinicaltrials.gov NCT04575519. Registered on October 5, 2020.

Indexed as

Mycobacterium tuberculosisTuberculosis, PulmonaryAdultAnti-Inflammatory AgentsAntitubercular AgentsAspirinClinical Trials, Phase II as TopicHumansIbuprofenMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeWorld Health OrganizationAnti-Inflammatory AgentsAntitubercular AgentsAspirinIbuprofenClinical trialHost-directed therapiesInfectious diseasesNon-steroidal anti-inflammatoriesRepurposed drugsTuberculosis

Identifiers

PMID37370174
PMCPMC10304643
OpenAlexW4382196729

What OpenQuestion holds

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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.