Evidence map›Paper›PMID 36876350›Full record

ArticleSouth African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde2023

Clinical impact of plasma concentrations of first-line antituberculosis drugs.

R Perumal, K Naidoo, A Naidoo, N Padayatchi

Registry-linked trialAbstract read
In one paragraph

Article in South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02114684 (An Open Label Randomized Controlled Clinical Trial Comparing a 24Week Oral Regimen Containing Moxifloxacin With a 24 Week Standard Drug Regimen for the Treatment of Smear-positive Pulmonary Tuberculosis in Patients Previously Treated for TB), 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
–field-weighted citation impact
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.

NCT02114684 phase1 / phase2completednot on this map

An Open Label Randomized Controlled Clinical Trial Comparing a 24Week Oral Regimen Containing Moxifloxacin With a 24 Week Standard Drug Regimen for the Treatment of Smear-positive Pulmonary Tuberculosis in Patients Previously Treated for TB

TypeinterventionalSponsorCentre for the AIDS Programme of Research in South AfricaRan2013 to 2017Enrolled197ConditionsRecurrent TuberculosisArmsmoxifloxacin
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  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

4 authors.

R PerumalCentre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa; Medical Research Council-CAPRISA HIV-TB Pathogenesis and Treatment Research Unit, Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa. rubeshanperumal@gmail.com.
K NaidooCentre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa; Medical Research Council-CAPRISA HIV-TB Pathogenesis and Treatment Research Unit, Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa. rubeshanperumal@gmail.com.
A NaidooCentre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa. rubeshanperumal@gmail.com.
N PadayatchiCentre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa 2 Medical Research Council-CAPRISA HIV-TB Pathogenesis and Treatment Research Unit, Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa. rubeshanperumal@gmail.com.

Funding

Second Generation InSTIs for the Treatment of HIV-1 in patients with TB co-infection on Rifampicin-based Treatment in KwaZulu Natal, South AfricaR01AI152142 · NIAID · CENTRE/AIDS PROGRAMME/RES/SOUTH AFRICA · PI DOOLEY, KELLY E., NAIDOO, ANUSHKA · 2020 to 2024
$2.9M
Dolutegravir for the treatment of HIV in patients with Tuberculosis in KwaZulu-Natal South AfricaK43TW011437 · FIC · CENTRE/AIDS PROGRAMME/RES/SOUTH AFRICA · PI NAIDOO, ANUSHKA · 2019 to 2023
$616k
FIC NIH HHS K43 TW011437Medical Research Council MC_PC_16022NIAID NIH HHS R01 AI152142
6 · The paper itself

Abstract

backgroundThe clinical significance of low antituberculosis (anti-TB) drug concentrations has not been fully elucidated.

objectivesTo investigate the clinical consequences of first-line drug concentrations in adult patients with drug-susceptible pulmonary TBin South Africa (SA).

methodWe conducted a pharmacokinetic study nested within the control arm of the Improving Treatment Success (IMPRESS) trial(NCT02114684) in Durban, SA. During the first 2 months of treatment, participants received weight-based dosing of first-line anti-TBdrugs (rifampicin, isoniazid, pyrazinamide and ethambutol), and had plasma drug concentrations measured at 2 and 6 hours after drugadministration during the 8th week of treatment. Intermediate (8 weeks), end-of-treatment (6 months) and follow-up TB outcomes wereassessed using World Health Organization criteria.

resultsWe measured plasma drug concentrations on available samples in 43 participants. Peak drug concentrations were below thetherapeutic range in 39/43 (90.7%) for rifampicin, 32/43 (74.4%) for isoniazid, 27/42 (64.3%) for pyrazinamide and 5/41 (12.2%) forethambutol. At the end of the intensive phase of treatment (week 8), 20.9% (n=9/43) of participants remained culture positive. We did notfind a relationship between the concentrations of first-line drugs and treatment outcomes at week 8. All participants were cured at the endof treatment, and there were no relapses during the 12-month follow-up period.

conclusionTreatment outcomes were favourable despite low drug concentrations as defined by current reference thresholds.

Indexed as

Antitubercular AgentsIsoniazidAdultHumansPyrazinamideRifampinSouth AfricaAntitubercular AgentsIsoniazidPyrazinamideRifampin

Identifiers

PMID36876350
PMCPMC10613123

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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.