Evidence map›Paper›PMID 34521664›Full record

ArticleBMJ open2021

Inhaled amikacin versus placebo to prevent ventilator-associated pneumonia: the AMIKINHAL double-blind multicentre randomised controlled trial protocol.

Elsa Tavernier, Francois Barbier, Ferhat Meziani, Jean-Pierre Quenot, Jean-Etienne Herbrecht, Mickael Landais, Damien Roux, Philippe Seguin, David Schnell, Anne Veinstein and 23 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03149640 (Double-blinded Multicenter Randomized Controlled Trial Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 30% 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.

NCT03149640 phase3completednot on this map

Double-blinded Multicenter Randomized Controlled Trial Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia

TypeinterventionalSponsorUniversity Hospital, ToursRan2017 to 2021Enrolled850ConditionsPneumonia, Ventilator-AssociatedArmsInhaled amikacin, Inhaled placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Review
  3. Lung Microbiome in Critically Ill Patients.Life (Basel, Switzerland) · 2021
    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

33 authors at 17 institutions in 1 country.

Elsa TavernierInserm CIC 1415, CHRU Tours, Tours, France.ORCID 0000-0003-0798-1182
Francois BarbierMédecine Intensive Réanimation, CHR d'Orléans, Orleans, France.
Ferhat MezianiService de Réanimation, Nouvel Hôpital Civil, Université de Strasbourg (UNISTRA), Faculté de Médecine, Hôpitaux universitaires de Strasbourg, Strasbourg, France.
Jean-Pierre QuenotDepartment of Intensive Care, Lipness Team, INSERM Research Centre LNC-UMR1231, LabExLipSTIC, and INSERM CIC 1432, Clinical Epidemiology, François Mitterrand University Hospital, University of Burgundy, Dijon, France.ORCID 0000-0003-2351-682X
Jean-Etienne HerbrechtMédecine Intensive Réanimation, Hôpital Hautepierre, Hôpitaux universitaires de Strasbourg, Strasbourg, France.ORCID 0000-0002-6415-5330
Mickael LandaisRéanimation médico-chirurgicale, CH du Mans, Le Mans, France.ORCID 0000-0001-5320-4013
Damien RouxMédecine Intensive Réanimation, Hôpital Louis Mourier, Assistance Publique - Hopitaux de Paris, Colombes, France.ORCID 0000-0002-6103-6416
Philippe SeguinRéanimation Chirurgicale, CHU Rennes, Rennes, France.
David SchnellRéanimation Polyvalente, CH Angouleme, Angouleme, France.ORCID 0000-0003-3665-1385
Anne VeinsteinMédecine Intensive Réanimation, CHU de Poitiers, Poitiers, France.
Benoît VeberRéanimation Chirurgicale, CHU de Rouen, Université de Rouen Normandie, Rouen, France.
Sigismond LasockiRéanimation Chirurgicale, CHU Angers, Angers, France.
Qin LuMultidisciplinary Critical Care Unit, Department of Anaesthesiology and Critical Care Medicine, Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.
Gaetan BeduneauMedical Intensive Care Unit, EA 3830, Normandie Université, UNIROUEN, Rouen University Hospital, Rouen, France.
Martine FerrandiereRéanimation Chirurgicale, CHRU Tours, Tours, France.ORCID 0000-0003-2264-8230
Claire Dahyot-FizelierRéanimation Chirurgicale, CHRU de Poitiers, Poitiers, France.
Gaetan PlantefeveRéanimation Polyvalente et Unité de Surveillance Continue, CH Victor Dupouy, Argenteuil, France.
Mai-Anh NayMédecine Intensive Réanimation, CHR d'Orléans, Orleans, France.ORCID 0000-0002-6116-4987
Hamid MerdjiService de Réanimation, Nouvel Hôpital Civil, Université de Strasbourg (UNISTRA), Faculté de Médecine, Hôpitaux universitaires de Strasbourg, Strasbourg, France.
Pascal AndreuDepartment of Intensive Care, Lipness Team, INSERM Research Centre LNC-UMR1231, LabExLipSTIC, and INSERM CIC 1432, Clinical Epidemiology, François Mitterrand University Hospital, University of Burgundy, Dijon, France.
Laurent VecellioCentre d'Etude des Pathologies Respiratoires, CEPR, INSERM U1100, Faculté de médecine, Université de Tours, Tours, France.
Grégoire MullerMédecine Intensive Réanimation, CHR d'Orléans, Orleans, France.ORCID 0000-0002-9284-3560
Maria CabreraCentre d'Etude des Pathologies Respiratoires, CEPR, INSERM U1100, Faculté de médecine, Université de Tours, Tours, France.
Deborah Le PennecCentre d'Etude des Pathologies Respiratoires, CEPR, INSERM U1100, Faculté de médecine, Université de Tours, Tours, France.
Renaud RespaudPharmacie, Centre d'Etude des Pathologies Respiratoires, CEPR, INSERM U1100, CHRU de Tours, Faculté de médecine, Université de Tours, Tours, France.
Philippe LanotteService de Bactériologie-Virologie, INRAE, ISP, CHRU de Tours, Université de Tours, Tours, France.
Nicolas GregoireINSERM UMR S1070, Laboratoire pharmacologie des anti-infectieux; Laboratoire de toxicologie-phamacologie, Université de Poitiers; CHU de Poitiers, Poitiers, France.
Marie LeclercDélégation à la Recherche Clinique et à l'Innovation, CHRU Tours, Tours, France.
Julie HelmsService de Réanimation, Nouvel Hôpital Civil, Université de Strasbourg (UNISTRA), Faculté de Médecine, Hôpitaux universitaires de Strasbourg, Strasbourg, France.
Thierry BoulainMédecine Intensive Réanimation, CHR d'Orléans, Orleans, France.ORCID 0000-0003-4664-3661
Jean-Claude LacheradeMédecine Intensive Réanimation, CHD de Vendée, La Roche-sur-Yon, France.
Stephan EhrmannMédecine Intensive Réanimation, CIC 1415, Centre d'Etude des Pathologies Respiratoires, CEPR, INSERM U1100, CHRU de Tours, Faculté de médecine, Université de Tours, Tours, France stephan.ehrmann@univ-tours.fr.ORCID 0000-0001-6221-4467
REVA network and the CRICS-TRIGGESEP F-CRIN network
Université de Tours · FRCentre hospitalier universitaire d'Orléans · FRHôpitaux Universitaires de Strasbourg · FRInserm · FRCentre Hospitalier Universitaire de Tours · FRCentre Hospitalier d'Angoulême · FRCentre Hospitalier Départemental Vendée · FRCentre Hospitalier du Mans · FRCentre Hospitalier Universitaire d'Angers · FRCentre Hospitalier Universitaire de Poitiers · FRCentre Hospitalier Universitaire de Rennes · FRCentre Hospitalier Universitaire de Rouen · FRCentre Hospitalier Victor Dupouy · FRHôpital Louis-Mourier · FRNormandie Université · FRSorbonne Université · FRUniversité de Poitiers · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPre-emptive inhaled antibiotics may be effective to reduce the occurrence of ventilator-associated pneumonia among critically ill patients. Meta-analysis of small sample size trials showed a favourable signal. Inhaled antibiotics are associated with a reduced emergence of antibiotic resistant bacteria. The aim of this trial is to evaluate the benefit of a 3-day course of inhaled antibiotics among patients undergoing invasive mechanical ventilation for more than 3 days on the occurrence of ventilator-associated pneumonia. METHODS AND ANALYSIS: Academic, investigator-initiated, parallel two group arms, double-blind, multicentre superiority randomised controlled trial. Patients invasively ventilated more than 3 days will be randomised to receive 20 mg/kg inhaled amikacin daily for 3 days or inhaled placebo (0.9% Sodium Chloride). Occurrence of ventilator-associated pneumonia will be recorded based on a standardised diagnostic framework from randomisation to day 28 and adjudicated by a centralised blinded committee. ETHICS AND DISSEMINATION: The protocol and amendments have been approved by the regional ethics review board and French competent authorities (Comité de protection des personnes Ouest I, No.2016-R29). All patients will be included after informed consent according to French law. Results will be disseminated in international scientific journals. TRIAL REGISTRATION NUMBERS: EudraCT 2016-001054-17 and NCT03149640.

Indexed as

AmikacinPneumonia, Ventilator-AssociatedAdministration, InhalationDouble-Blind MethodEquivalence Trials as TopicHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicRespiration, ArtificialTreatment OutcomeAmikacinadult intensive & critical careclinical trialsinfectious diseasesrespiratory infections

Identifiers

PMID34521664
PMCPMC8442072
OpenAlexW3199560928

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.