Evidence map›Paper›PMID 38844921›Full record

Trial reportRespiratory research2024

Systemic antibiotics for Pseudomonas aeruginosa infection in outpatients with non-hospitalised exacerbations of pre-existing lung diseases: a randomised clinical trial.

Josefin Eklöf, Imane Achir Alispahic, Karin Armbruster, Therese Sophie Lapperre, Andrea Browatzki, Rikke Holmen Overgaard, Zitta Barrella Harboe, Julie Janner, Mia Moberg, Charlotte Suppli Ulrik and 17 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Respiratory research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03262142 (Targeted AntiBiotics for Chronic Pulmonary Disease), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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.

NCT03262142 phase4terminatednot on this map

Targeted AntiBiotics for Chronic Pulmonary Disease: Can Targeted Antibiotic Therapy Improve the Prognosis of Pseudomonas Aeruginosa Infected Patients With Chronic Pulmonary Obstructive Disease, Non-cystic Fibrosis Bronchiectasis and Asthma? A Multicenter, Randomized, Controlled, Open-label Trial.

TypeinterventionalSponsorChronic Obstructive Pulmonary Disease Trial Network, DenmarkRan2018 to 2023Enrolled51ConditionsCOPD, Respiratory Tract Infections, Pseudomonas Aeruginosa, BronchiectasisArmsPiperacillin/tazobactam, Ciprofloxacin
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. 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

27 authors.

Josefin EklöfDepartment of Internal Medicine, Herlev Gentofte University Hospital, Section of Respiratory Medicine, Copenhagen University Hospital, Herlev Gentofte, Hellerup, Denmark. josefin.viktoria.ekloef@regionh.dk.
Imane Achir AlispahicDepartment of Internal Medicine, Herlev Gentofte University Hospital, Section of Respiratory Medicine, Copenhagen University Hospital, Herlev Gentofte, Hellerup, Denmark.
Karin ArmbrusterDepartment of Internal Medicine, Herlev Gentofte University Hospital, Section of Respiratory Medicine, Copenhagen University Hospital, Herlev Gentofte, Hellerup, Denmark.
Therese Sophie LapperreDepartment of Respiratory Medicine and Infectious Diseases, Copenhagen University Hospital, Bispebjerg Frederiksberg, Denmark.
Andrea BrowatzkiDepartment of Respiratory Medicine and Infectious Diseases, Copenhagen University Hospital, North Zealand, Denmark.
Rikke Holmen OvergaardDepartment of Respiratory Medicine and Infectious Diseases, Copenhagen University Hospital, North Zealand, Denmark.
Zitta Barrella HarboeDepartment of Respiratory Medicine and Infectious Diseases, Copenhagen University Hospital, North Zealand, Denmark.
Julie JannerDepartment of Respiratory Medicine, Copenhagen University Hospital, Hvidovre, Denmark.
Mia MobergDepartment of Respiratory Medicine, Copenhagen University Hospital, Hvidovre, Denmark.
Charlotte Suppli UlrikDepartment of Respiratory Medicine, Copenhagen University Hospital, Hvidovre, Denmark.
Helle Frost AndreassenDepartment of Respiratory Medicine and Infectious Diseases, Copenhagen University Hospital, Bispebjerg Frederiksberg, Denmark.
Ulla Møller WeinreichDepartment of Respiratory Medicine, Aalborg University Hospital and Department of Clinical Medicine, Aalborg, Denmark.
Jakob Lyngby KjærgaardDepartment of Internal Medicine, Herlev Gentofte University Hospital, Section of Respiratory Medicine, Copenhagen University Hospital, Herlev Gentofte, Hellerup, Denmark.
Jenny VilladsenDepartment of Internal Medicine, Herlev Gentofte University Hospital, Section of Respiratory Medicine, Copenhagen University Hospital, Herlev Gentofte, Hellerup, Denmark.
Camilla Sund FenlevLaboratory of Experimental Medicine and Pediatrics, University of Antwerp, Antwerp, Belgium.
Torben Tranborg JensenDepartment of Internal Medicine, Hospital of Southwest Jutland, Esbjerg, Denmark.
Christina Wellendorph ChristensenDepartment of Clinical Microbiology, Copenhagen University Hospital, Herlev, Denmark.
Jette BangsborgDepartment of Clinical Microbiology, Copenhagen University Hospital, Herlev, Denmark.
Christian OstergaardDepartment of Clinical Microbiology, Copenhagen University Hospital, Hvidovre, Denmark.
Khaled Saoud Ali GhathianDepartment of Clinical Microbiology, Copenhagen University Hospital, Hvidovre, Denmark.
Alexander JordanDepartment of Internal Medicine, Herlev Gentofte University Hospital, Section of Respiratory Medicine, Copenhagen University Hospital, Herlev Gentofte, Hellerup, Denmark.
Tobias Wirenfeldt KlausenDepartment of Internal Medicine, Herlev Gentofte University Hospital, Section of Respiratory Medicine, Copenhagen University Hospital, Herlev Gentofte, Hellerup, Denmark.
Thyge Lynghøj NielsenDepartment of Respiratory Medicine and Infectious Diseases, Copenhagen University Hospital, North Zealand, Denmark.
Torgny WilckeDepartment of Internal Medicine, Herlev Gentofte University Hospital, Section of Respiratory Medicine, Copenhagen University Hospital, Herlev Gentofte, Hellerup, Denmark.
Niels SeersholmDepartment of Internal Medicine, Herlev Gentofte University Hospital, Section of Respiratory Medicine, Copenhagen University Hospital, Herlev Gentofte, Hellerup, Denmark.
Pradeesh SivapalanDepartment of Internal Medicine, Herlev Gentofte University Hospital, Section of Respiratory Medicine, Copenhagen University Hospital, Herlev Gentofte, Hellerup, Denmark.
Jens-Ulrik Stæhr JensenDepartment of Internal Medicine, Herlev Gentofte University Hospital, Section of Respiratory Medicine, Copenhagen University Hospital, Herlev Gentofte, Hellerup, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe effect of dual systemic antibiotic therapy against Pseudomonas aeruginosa in patients with pre-existing lung disease is unknown. To assess whether dual systemic antibiotics against P. aeruginosa in outpatients with COPD, non-cystic fibrosis (non-CF) bronchiectasis, or asthma can improve outcomes.

methodsMulticenter, randomised, open-label trial conducted at seven respiratory outpatient clinics in Denmark. Outpatients with COPD, non-CF bronchiectasis, or asthma with a current P. aeruginosa-positive lower respiratory tract culture (clinical routine samples obtained based on symptoms of exacerbation not requiring hospitalisation), regardless of prior P. aeruginosa-status, no current need for hospitalisation, and at least two moderate or one hospitalisation-requiring exacerbation within the last year were eligible. Patients were assigned 1:1 to 14 days of dual systemic anti-pseudomonal antibiotics or no antibiotic treatment. Primary outcome was time to prednisolone or antibiotic-requiring exacerbation or death from day 20 to day 365.

resultsThe trial was stopped prematurely based in lack of recruitment during the COVID-19 pandemic, this decision was endorsed by the Data and Safety Monitoring Board. Forty-nine outpatients were included in the study. There was a reduction in risk of the primary outcome in the antibiotic group compared to the control group (HR 0.51 (95%CI 0.27-0.96), p = 0.037). The incidence of admissions with exacerbation within one year was 1.1 (95%CI 0.6-1.7) in the dual antibiotic group vs. 2.9 (95%CI 1.3-4.5) in the control group, p = 0.037.

conclusionsUse of dual systemic antibiotics for 14 days against P. aeruginosa in outpatients with chronic lung diseases and no judged need for hospitalisation, improved clinical outcomes markedly. The main limitation was the premature closure of the trial.

trial registrationClinicalTrials.gov, NCT03262142, registration date 2017-08-25.

Indexed as

Anti-Bacterial AgentsOutpatientsPseudomonas aeruginosaPseudomonas InfectionsAgedDenmarkDisease ProgressionFemaleHospitalizationHumansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveTreatment OutcomeAnti-Bacterial Agents

Identifiers

PMID38844921
PMCPMC11157704

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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.