Evidence map›Paper›PMID 32589648›Full record

Trial reportPloS one2020

Safety and efficacy of N-acetylcysteine in hospitalized patients with HIV-associated tuberculosis: An open-label, randomized, phase II trial (RIPENACTB Study).

Izabella Picinin Safe, Marcus Vinícius Guimarães Lacerda, Vitoria Silva Printes, Adriana Ferreira Praia Marins, Amanda Lia Rebelo Rabelo, Amanda Araújo Costa, Michel Araújo Tavares, Jaquelane Silva Jesus, Alexandra Brito Souza, Francisco Beraldi-Magalhães and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07058090 (Comparison of the Outcome of Treatment With Silymarin or N-Aceylcysteine in Patients Taking Anti-Tuberculous Drugs for Tuberculosis at a Tertiary Care Hospital , Karachi), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 14% 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.

NCT07058090 phase1not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Comparison of the Outcome of Treatment With Silymarin or N-Aceylcysteine in Patients Taking Anti-Tuberculous Drugs for Tuberculosis at a Tertiary Care Hospital , Karachi

TypeinterventionalSponsorLiaquat National Hospital & Medical CollegeRan2025 to 2026Enrolled410ConditionsDrug Induced Liver Injury, Tuberculosis (TB)ArmsSilymarin 420 mg, N Acetyl Cysteine, Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
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  10. The promises and limitations ofAntimicrobial agents and chemotherapy · 2023
    Article
  11. Development of DipeptidePharmaceutics · 2023
    Article
  12. Impact ofAntioxidants (Basel, Switzerland) · 2022
    Review
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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

17 authors at 5 institutions in 3 countries.

Izabella Picinin SafeFundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.
Marcus Vinícius Guimarães LacerdaFundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.ORCID 0000-0003-3374-9985
Vitoria Silva PrintesFundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.
Adriana Ferreira Praia MarinsFundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.
Amanda Lia Rebelo RabeloPrograma de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil.
Amanda Araújo CostaFundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.
Michel Araújo TavaresUniversidade Federal do Amazonas, Manaus, Brazil.
Jaquelane Silva JesusFundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.ORCID 0000-0002-1865-5473
Alexandra Brito SouzaPrograma de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil.
Francisco Beraldi-MagalhãesPrograma de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil.
Cynthia Pessoa NevesFundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.
Wuelton Marcelo MonteiroFundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.
Vanderson Souza SampaioFundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.
Eduardo P AmaralImmunobiology Section, National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
Renata Spener GomesPrograma de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil.
Bruno B AndradeLaboratório de Inflamação e Biomarcadores, Instituto Gonçalo Moniz, Fundação Oswaldo Cruz (FIOCRUZ), Salvador, Brazil.ORCID 0000-0001-6833-3811
Marcelo Cordeiro-SantosFundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.
Fundação de Medicina Tropical · BRUniversidade do Estado do Amazonas · BREscola Bahiana de Medicina e Saúde Pública · BRNational Institutes of Health · USUniversidade Federal do Amazonas · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Despite the availability of effective antimicrobials, tuberculosis (TB) is still a serious health threat. Mortality is even higher in people living with HIV who are diagnosed with TB. New therapies are needed to shorten the time required to cure TB and decrease fatality rates in this population. N-acetylcysteine (NAC) is a glutathione precursor and has shown recently in experimental setting to present in vitro and in vivo anti-mycobacterial activity. We test the hypothesis that NAC is safe, well tolerated and secondarily efficacious as adjunctive anti-TB therapy in hospitalized individuals with HIV-associated TB. Patients were enrolled sequentially in a tertiary care center, in the Brazilian Amazon. We performed a randomized, parallel group, single-center, open study trial of two arms, in hospitalized patients over 18 years of age, with microbiologically confirmed pulmonary TB in HIV: one with rifampicin, isoniazid, pyrazinamide and ethambutol at standard doses (Control Group), and a second in which NAC 600 mg bid for eight weeks was added (NAC Group). A total of 21 and 18 patients were enrolled to the Control Group and NAC Group, respectively. Adverse event rates were similar in the two arms. Our findings suggest that in the more critical population of hospitalized patients with HIV-associated TB, the use of NAC was not unsafe, despite the low sample size, and a potential impact on faster negative cultures needs to be further explored in larger studies.

Indexed as

HospitalizationSafetyAcetylcysteineAdultFemaleHIV InfectionsHumansMaleMiddle AgedTuberculosisAcetylcysteine

Identifiers

PMID32589648
PMCPMC7319340
OpenAlexW3037277062

What OpenQuestion holds

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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.