Evidence map›Paper›PMID 28438118›Full record

Trial reportBMC infectious diseases2017

Predictors of delayed culture conversion among Ugandan patients.

Daniel Atwine, Patrick Orikiriza, Ivan Taremwa, Arnold Ayebare, Suzan Logoose, Juliet Mwanga-Amumpaire, Amina Jindani, Maryline Bonnet

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC infectious diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 33% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
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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

8 authors at 3 institutions in 3 countries.

Daniel AtwineEpicentre Mbarara Research Centre, PO box 1956, Mbarara, Uganda. atwine.daniel@epicentre.msf.org.
Patrick OrikirizaEpicentre Mbarara Research Centre, PO box 1956, Mbarara, Uganda.
Ivan TaremwaEpicentre Mbarara Research Centre, PO box 1956, Mbarara, Uganda.
Arnold AyebareEpicentre Mbarara Research Centre, PO box 1956, Mbarara, Uganda.
Suzan LogooseEpicentre Mbarara Research Centre, PO box 1956, Mbarara, Uganda.
Juliet Mwanga-AmumpaireEpicentre Mbarara Research Centre, PO box 1956, Mbarara, Uganda.
Amina JindaniSt. George's, University of London, London, UK.
Maryline BonnetEpicentre Mbarara Research Centre, PO box 1956, Mbarara, Uganda.
Epicentre Uganda · UGMbarara University of Science and Technology · UGSt George's, University of London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEstimates of month-2 culture conversion, a proxy indicator of tuberculosis (TB) treatment efficacy in phase-2 trials can vary by culture-type and geographically with lower rates reported among African sites. The sub-study aimed at comparing TB detection rates of different culture media, within and across rifampicin-based regimens (R10, 15 and 20 mg/Kg) over a 6-month treatment follow-up period, and to establish predictors of month-2 culture non-conversion among HIV-negative TB patients enrolled at RIFATOX trial site in Uganda.

methodsUnlike in other Rifatox Trial sites, it is only in Uganda were Lowenstein-Jensen (LJ) and Mycobacteria growth indicator tube (MGIT) were used throughout 6-months for treatment monitoring. Conversion rates were compared at month-2, 4 and 6 across cultures and treatment-type. Binomial regression analysis performed for predictors of month-2 non-conversion.

resultsOf the 100 enrolled patients, 45% had converted based on combined LJ and MGIT by month-2, with no significant differences across treatment arms, p = 0.721. LJ exhibited higher conversion rates than MGIT at month-2 (58.4% vs 56.0%, p = 0.0707) and month-4 (98.9% vs 88.4%, p = 0.0391) respectively, more so within the high-dose rifampicin arms. All patients had converted by month-6. Time-to-TB detection (TTD) on MGIT and social service jobs independently predict month-2 non-conversion.

conclusionThe month-2 culture conversion used in phase 2 clinical trials as surrogate marker of treatment efficacy is influenced by the culture method used for monitoring mycobacterial response to TB treatment. Therefore, multi-centric TB therapeutic trials using early efficacy endpoint should use the same culture method across sites. The Time-to-detection of MTB on MGIT prior to treatment and working in Social service jobs bear an increased risk of culture non-conversion at month-2.

trial registrationISRCTN ISRCTN55670677 . Registered 09th November 2010. Retrospectively registered.

Indexed as

AdolescentAdultAntibiotics, AntitubercularCulture MediaFemaleFollow-Up StudiesHumansMaleMiddle AgedMycobacterium tuberculosisRetrospective StudiesRifampinSputumTreatment OutcomeTuberculosisUgandaAntibiotics, AntitubercularCulture MediaRifampinDelayed culture conversionEfficacyHIV-negative TB patientsTime-to-detectionTreatment failure

Identifiers

PMID28438118
PMCPMC5402635
OpenAlexW2608778408

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.