View in EDS

Discontinuing β-lactam treatment after 3 days for patients with community-acquired pneumonia in non-critical care wards (PTC): a double-blind, randomised, placebo-controlled, non-inferiority trial.

Saved in:
Bibliographic Details
Title: Discontinuing β-lactam treatment after 3 days for patients with community-acquired pneumonia in non-critical care wards (PTC): a double-blind, randomised, placebo-controlled, non-inferiority trial.
Authors: Dinh, Aurélien (AUTHOR), Ropers, Jacques (AUTHOR), Duran, Clara (AUTHOR), Davido, Benjamin (AUTHOR), Deconinck, Laurène (AUTHOR), Matt, Morgan (AUTHOR), Senard, Olivia (AUTHOR), Lagrange, Aurore (AUTHOR), Makhloufi, Sabrina (AUTHOR), Mellon, Guillaume (AUTHOR), de Lastours, Victoire (AUTHOR), Bouchand, Frédérique (AUTHOR), Mathieu, Emmanuel (AUTHOR), Kahn, Jean-Emmanuel (AUTHOR), Rouveix, Elisabeth (AUTHOR), Grenet, Julie (AUTHOR), Dumoulin, Jennifer (AUTHOR), Chinet, Thierry (AUTHOR), Pépin, Marion (AUTHOR), Delcey, Véronique (AUTHOR)
Source: Lancet. 3/27/2021, Vol. 397 Issue 10280, p1195-1203. 9p.
Subjects: Community-acquired pneumonia, Medical personnel, Acute kidney failure, Cardiogenic shock, Pulmonary edema, Treatment duration
Geographic Terms: France
Abstract: Background: Shortening the duration of antibiotic therapy for patients admitted to hospital with community-acquired pneumonia should help reduce antibiotic consumption and thus bacterial resistance, adverse events, and related costs. We aimed to assess the need for an additional 5-day course of β-lactam therapy among patients with community-acquired pneumonia who were stable after 3 days of treatment.Methods: We did this double-blind, randomised, placebo-controlled, non-inferiority trial (the Pneumonia Short Treatment [PTC]) in 16 centres in France. Adult patients (aged ≥18 years) admitted to hospital with moderately severe community-acquired pneumonia (defined as patients admitted to a non-critical care unit) and who met prespecified clinical stability criteria after 3 days of treatment with β-lactam therapy were randomly assigned (1:1) to receive β-lactam therapy (oral amoxicillin 1 g plus clavulanate 125 mg three times a day) or matched placebo for 5 extra days. Randomisation was done using a web-based system with permuted blocks with random sizes and stratified by randomisation site and Pneumonia Severity Index score. Participants, clinicians, and study staff were masked to treatment allocation. The primary outcome was cure 15 days after first antibiotic intake, defined by apyrexia (temperature ≤37·8°C), resolution or improvement of respiratory symptoms, and no additional antibiotic treatment for any cause. A non-inferiority margin of 10 percentage points was chosen. The primary outcome was assessed in all patients who were randomly assigned and received any treatment (intention-to-treat [ITT] population) and in all patients who received their assigned treatment (per-protocol population). Safety was assessed in the ITT population. This study is registered with ClinicalTrials.gov, NCT01963442, and is now complete.Findings: Between Dec 19, 2013, and Feb 1, 2018, 706 patients were assessed for eligibility, and after 3 days of β-lactam treatment, 310 eligible patients were randomly assigned to receive either placebo (n=157) or β-lactam treatment (n=153). Seven patients withdrew consent before taking any study drug, five in the placebo group and two in the β-lactam group. In the ITT population, median age was 73·0 years (IQR 57·0-84·0) and 123 (41%) of 303 participants were female. In the ITT analysis, cure at day 15 occurred in 117 (77%) of 152 participants in the placebo group and 102 (68%) of 151 participants in the β-lactam group (between-group difference of 9·42%, 95% CI -0·38 to 20·04), indicating non-inferiority. In the per-protocol analysis, 113 (78%) of 145 participants in the placebo treatment group and 100 (68%) of 146 participants in the β-lactam treatment group were cured at day 15 (difference of 9·44% [95% CI -0·15 to 20·34]), indicating non-inferiority. Incidence of adverse events was similar between the treatment groups (22 [14%] of 152 in the placebo group and 29 [19%] of 151 in the β-lactam group). The most common adverse events were digestive disorders, reported in 17 (11%) of 152 patients in the placebo group and 28 (19%) of 151 patients in the β-lactam group. By day 30, three (2%) patients had died in the placebo group (one due to bacteraemia due to Staphylococcus aureus, one due to cardiogenic shock after acute pulmonary oedema, and one due to heart failure associated with acute renal failure) and two (1%) in the β-lactam group (due to pneumonia recurrence and possible acute pulmonary oedema).Interpretation: Among patients admitted to hospital with community-acquired pneumonia who met clinical stability criteria, discontinuing β-lactam treatment after 3 days was non-inferior to 8 days of treatment. These findings could allow substantial reduction of antibiotic consumption.Funding: French Ministry of Health. [ABSTRACT FROM AUTHOR]
Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
FullText Text:
  Availability: 0
Header DbId: pbh
DbLabel: Psychology and Behavioral Sciences Collection
An: 149510688
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Discontinuing β-lactam treatment after 3 days for patients with community-acquired pneumonia in non-critical care wards (PTC): a double-blind, randomised, placebo-controlled, non-inferiority trial.
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AR" term="%22Dinh%2C+Aurélien%22">Dinh, Aurélien</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ropers%2C+Jacques%22">Ropers, Jacques</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Duran%2C+Clara%22">Duran, Clara</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Davido%2C+Benjamin%22">Davido, Benjamin</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Deconinck%2C+Laurène%22">Deconinck, Laurène</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Matt%2C+Morgan%22">Matt, Morgan</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Senard%2C+Olivia%22">Senard, Olivia</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lagrange%2C+Aurore%22">Lagrange, Aurore</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Makhloufi%2C+Sabrina%22">Makhloufi, Sabrina</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Mellon%2C+Guillaume%22">Mellon, Guillaume</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22de+Lastours%2C+Victoire%22">de Lastours, Victoire</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bouchand%2C+Frédérique%22">Bouchand, Frédérique</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Mathieu%2C+Emmanuel%22">Mathieu, Emmanuel</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kahn%2C+Jean-Emmanuel%22">Kahn, Jean-Emmanuel</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Rouveix%2C+Elisabeth%22">Rouveix, Elisabeth</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Grenet%2C+Julie%22">Grenet, Julie</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Dumoulin%2C+Jennifer%22">Dumoulin, Jennifer</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Chinet%2C+Thierry%22">Chinet, Thierry</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pépin%2C+Marion%22">Pépin, Marion</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Delcey%2C+Véronique%22">Delcey, Véronique</searchLink> (AUTHOR)
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 3/27/2021, Vol. 397 Issue 10280, p1195-1203. 9p.
– Name: Subject
  Label: Subjects
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22Community-acquired+pneumonia%22">Community-acquired pneumonia</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+personnel%22">Medical personnel</searchLink><br /><searchLink fieldCode="DE" term="%22Acute+kidney+failure%22">Acute kidney failure</searchLink><br /><searchLink fieldCode="DE" term="%22Cardiogenic+shock%22">Cardiogenic shock</searchLink><br /><searchLink fieldCode="DE" term="%22Pulmonary+edema%22">Pulmonary edema</searchLink><br /><searchLink fieldCode="DE" term="%22Treatment+duration%22">Treatment duration</searchLink>
– Name: SubjectGeographic
  Label: Geographic Terms
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22France%22">France</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: <bold>Background: </bold>Shortening the duration of antibiotic therapy for patients admitted to hospital with community-acquired pneumonia should help reduce antibiotic consumption and thus bacterial resistance, adverse events, and related costs. We aimed to assess the need for an additional 5-day course of β-lactam therapy among patients with community-acquired pneumonia who were stable after 3 days of treatment.<bold>Methods: </bold>We did this double-blind, randomised, placebo-controlled, non-inferiority trial (the Pneumonia Short Treatment [PTC]) in 16 centres in France. Adult patients (aged ≥18 years) admitted to hospital with moderately severe community-acquired pneumonia (defined as patients admitted to a non-critical care unit) and who met prespecified clinical stability criteria after 3 days of treatment with β-lactam therapy were randomly assigned (1:1) to receive β-lactam therapy (oral amoxicillin 1 g plus clavulanate 125 mg three times a day) or matched placebo for 5 extra days. Randomisation was done using a web-based system with permuted blocks with random sizes and stratified by randomisation site and Pneumonia Severity Index score. Participants, clinicians, and study staff were masked to treatment allocation. The primary outcome was cure 15 days after first antibiotic intake, defined by apyrexia (temperature ≤37·8°C), resolution or improvement of respiratory symptoms, and no additional antibiotic treatment for any cause. A non-inferiority margin of 10 percentage points was chosen. The primary outcome was assessed in all patients who were randomly assigned and received any treatment (intention-to-treat [ITT] population) and in all patients who received their assigned treatment (per-protocol population). Safety was assessed in the ITT population. This study is registered with ClinicalTrials.gov, NCT01963442, and is now complete.<bold>Findings: </bold>Between Dec 19, 2013, and Feb 1, 2018, 706 patients were assessed for eligibility, and after 3 days of β-lactam treatment, 310 eligible patients were randomly assigned to receive either placebo (n=157) or β-lactam treatment (n=153). Seven patients withdrew consent before taking any study drug, five in the placebo group and two in the β-lactam group. In the ITT population, median age was 73·0 years (IQR 57·0-84·0) and 123 (41%) of 303 participants were female. In the ITT analysis, cure at day 15 occurred in 117 (77%) of 152 participants in the placebo group and 102 (68%) of 151 participants in the β-lactam group (between-group difference of 9·42%, 95% CI -0·38 to 20·04), indicating non-inferiority. In the per-protocol analysis, 113 (78%) of 145 participants in the placebo treatment group and 100 (68%) of 146 participants in the β-lactam treatment group were cured at day 15 (difference of 9·44% [95% CI -0·15 to 20·34]), indicating non-inferiority. Incidence of adverse events was similar between the treatment groups (22 [14%] of 152 in the placebo group and 29 [19%] of 151 in the β-lactam group). The most common adverse events were digestive disorders, reported in 17 (11%) of 152 patients in the placebo group and 28 (19%) of 151 patients in the β-lactam group. By day 30, three (2%) patients had died in the placebo group (one due to bacteraemia due to Staphylococcus aureus, one due to cardiogenic shock after acute pulmonary oedema, and one due to heart failure associated with acute renal failure) and two (1%) in the β-lactam group (due to pneumonia recurrence and possible acute pulmonary oedema).<bold>Interpretation: </bold>Among patients admitted to hospital with community-acquired pneumonia who met clinical stability criteria, discontinuing β-lactam treatment after 3 days was non-inferior to 8 days of treatment. These findings could allow substantial reduction of antibiotic consumption.<bold>Funding: </bold>French Ministry of Health. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=149510688
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1016/S0140-6736(21)00313-5
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 9
        StartPage: 1195
    Subjects:
      – SubjectFull: Community-acquired pneumonia
        Type: general
      – SubjectFull: Medical personnel
        Type: general
      – SubjectFull: Acute kidney failure
        Type: general
      – SubjectFull: Cardiogenic shock
        Type: general
      – SubjectFull: Pulmonary edema
        Type: general
      – SubjectFull: Treatment duration
        Type: general
      – SubjectFull: France
        Type: general
    Titles:
      – TitleFull: Discontinuing β-lactam treatment after 3 days for patients with community-acquired pneumonia in non-critical care wards (PTC): a double-blind, randomised, placebo-controlled, non-inferiority trial.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Dinh, Aurélien
      – PersonEntity:
          Name:
            NameFull: Ropers, Jacques
      – PersonEntity:
          Name:
            NameFull: Duran, Clara
      – PersonEntity:
          Name:
            NameFull: Davido, Benjamin
      – PersonEntity:
          Name:
            NameFull: Deconinck, Laurène
      – PersonEntity:
          Name:
            NameFull: Matt, Morgan
      – PersonEntity:
          Name:
            NameFull: Senard, Olivia
      – PersonEntity:
          Name:
            NameFull: Lagrange, Aurore
      – PersonEntity:
          Name:
            NameFull: Makhloufi, Sabrina
      – PersonEntity:
          Name:
            NameFull: Mellon, Guillaume
      – PersonEntity:
          Name:
            NameFull: de Lastours, Victoire
      – PersonEntity:
          Name:
            NameFull: Bouchand, Frédérique
      – PersonEntity:
          Name:
            NameFull: Mathieu, Emmanuel
      – PersonEntity:
          Name:
            NameFull: Kahn, Jean-Emmanuel
      – PersonEntity:
          Name:
            NameFull: Rouveix, Elisabeth
      – PersonEntity:
          Name:
            NameFull: Grenet, Julie
      – PersonEntity:
          Name:
            NameFull: Dumoulin, Jennifer
      – PersonEntity:
          Name:
            NameFull: Chinet, Thierry
      – PersonEntity:
          Name:
            NameFull: Pépin, Marion
      – PersonEntity:
          Name:
            NameFull: Delcey, Véronique
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 27
              M: 03
              Text: 3/27/2021
              Type: published
              Y: 2021
          Identifiers:
            – Type: issn-print
              Value: 01406736
          Numbering:
            – Type: volume
              Value: 397
            – Type: issue
              Value: 10280
          Titles:
            – TitleFull: Lancet
              Type: main
ResultId 1