Evidence map›Paper›PMID 26082623›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2015

Prognostic factors for clinical failure of exacerbations in elderly outpatients with moderate-to-severe COPD.

Robert Wilson, Antonio Anzueto, Marc Miravitlles, Pierre Arvis, Daniel Haverstock, Mila Trajanovic, Sanjay Sethi

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

Trial report in International journal of chronic obstructive pulmonary disease, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00656747 (MAESTRAL - A Prospective, Multinational, Multicenter, Randomized, Double Blind, Double Dummy, Controlled Study Comparing the Efficacy and Safety of Moxifloxacin to That of Amoxicillin Clavulanic Acid for the Treatment of Subjects With Acute Exacerbations of Chronic Bronchitis.), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.7field-weighted citation impact, top 26% 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.

NCT00656747 phase4completednot on this map

MAESTRAL - A Prospective, Multinational, Multicenter, Randomized, Double Blind, Double Dummy, Controlled Study Comparing the Efficacy and Safety of Moxifloxacin to That of Amoxicillin Clavulanic Acid for the Treatment of Subjects With Acute Exacerbations of Chronic Bronchitis.

TypeinterventionalSponsorBayerRan2008 to 2010Enrolled1,372ConditionsChronic BronchitisArmsAvelox (Moxifloxacin, BAY12-8039), Amoxicillin clavulanic acid
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Review
  3. Clinical Features and C-Reactive Protein as Predictors of Bacterial Exacerbations of COPD.International journal of chronic obstructive pulmonary disease · 2020
    Article
  4. Article
  5. Acute exacerbations of COPD: risk factors for failure and relapse.International journal of chronic obstructive pulmonary disease · 2017
    Review
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

7 authors at 7 institutions in 5 countries.

Robert WilsonHost Defence Unit, Royal Brompton Hospital, London, UK.
Antonio AnzuetoUniversity of Texas Health Science Center, South Texas Veterans Health Care System, San Antonio, TX, USA.
Marc MiravitllesPneumology Department, Hospital Universitari Vall d'Hebron, CIBER de Enfermedades Respiratorias (CIBERES), Barcelona, Spain.
Pierre ArvisBayer HealthCare Pharmaceuticals, Loos, France.
Daniel HaverstockBayer HealthCare Pharmaceuticals, Whippany, NJ, USA.
Mila TrajanovicBayer HealthCare Pharmaceuticals, Toronto, ON, Canada.
Sanjay SethiUniversity at Buffalo, Buffalo, NY, USA.
Bayer (Canada) · CABayer (France) · FRBayer (United States) · USCentro de Investigación Biomédica en Red de Enfermedades Respiratorias · ESRoyal Brompton Hospital · GBThe University of Texas Health Science Center at San Antonio · USUniversity at Buffalo, State University of New York · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcute exacerbations represent a significant burden for patients with moderate-to-severe chronic obstructive pulmonary disease. Each exacerbation episode is frequently associated with a lengthy recovery and impaired quality of life. Prognostic factors for outpatients that may predict poor outcome after treatment with antibiotics recommended in the guidelines, are not fully understood. We aimed to identify pretherapy factors predictive of clinical failure in elderly (≥60 years old) outpatients with acute Anthonisen type 1 exacerbations.

trial registrationNCT00656747.

methodsBased on the moxifloxacin in AECOPDs (acute exacerbations of chronic obstructive pulmonary disease) trial (MAESTRAL) database, this study evaluated pretherapy demographic, clinical, sputum bacteriological factors using multivariate logistic regression analysis, with internal validation by bootstrap replicates, to investigate their possible association with clinical failure at end of therapy (EOT) and 8 weeks posttherapy.

resultsThe analyses found that the independent factors predicting clinical failure at EOT were more frequent exacerbations, increased respiratory rate and lower body temperature at exacerbation, treatment with long-acting anticholinergic drugs, and in vitro bacterial resistance to study drug. The independent factors predicting poor outcome at 8 weeks posttherapy included wheezing at preexacerbation, mild or moderate (vs extreme) sleep disturbances, lower body temperature at exacerbation, forced expiratory volume in 1 second <30%, lower body mass index, concomitant systemic corticosteroids for the current exacerbation, maintenance long-acting β2-agonist and long-acting anticholinergic treatments, and positive sputum culture at EOT.

conclusionSeveral bacteriological, historical, treatment-related factors were identified as predictors of early (EOT) and later (8 weeks posttherapy) clinical failure in this older outpatient population with moderate-to-severe chronic obstructive pulmonary disease. These patients should be closely monitored and sputum cultures considered before and after treatment.

Indexed as

AgedAge FactorsAmbulatory CareAmoxicillin-Potassium Clavulanate CombinationAnti-Bacterial AgentsChi-Square DistributionDisease ProgressionDouble-Blind MethodFemaleFluoroquinolonesForced Expiratory VolumeHumansLogistic ModelsLungMaleMiddle AgedAmoxicillin-Potassium Clavulanate CombinationAnti-Bacterial AgentsFluoroquinolonesMoxifloxacinAECOPDclinical failurelong-term outcomepoor outcomeprognostic factor

Identifiers

PMID26082623
PMCPMC4459615
OpenAlexW1872351382

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.