An open-label, randomized, non-inferiority trial of the efficacy and safety of ciprofloxacin versus an aminoglycoside + ciprofloxacin in the treatment of bubonic plague (IMASOY): study protocol for a randomized control trial-an update to the published protocol.

Ciprofloxacin / adverse effects Treatment Outcome Humans Anti-Bacterial Agents / adverse effects Plague / drug therapy Randomized Controlled Trials as Topic Equivalence Trials as Topic Drug Therapy, Combination Animals Aminoglycosides / adverse effects

Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
05 Jul 2024
Historique:
received: 30 05 2024
accepted: 27 06 2024
medline: 6 7 2024
pubmed: 6 7 2024
entrez: 5 7 2024
Statut: epublish

Résumé

This article reports an update to the protocol of the IMASOY trial, which was prospectively registered on clinicaltrials.gov (NCT04110340) in October 2019.

Identifiants

DOI: 10.1186/s13063-024-08302-7 PMID: 38970065
pubmed: 38970065
doi: 10.1186/s13063-024-08302-7
pii: 10.1186/s13063-024-08302-7
doi:

Substances chimiques

Ciprofloxacin 5E8K9I0O4U
Anti-Bacterial Agents 0
Aminoglycosides 0

Banques de données

ClinicalTrials.gov
['NCT04110340']

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

457

Subventions

Organisme : UK Foreign Commonwealth and Development Office and Wellcome
ID : 216273/Z/19/Z

Informations de copyright

© 2024. The Author(s).

Références

Randremanana RV, Raberahona M, Randria MJD, Rajerison M, Andrianaivoarimanana V, Legrand A, et al. An open-label, randomized, non-inferiority trial of the efficacy and safety of ciprofloxacin versus streptomycin + ciprofloxacin in the treatment of bubonic plague (IMASOY): study protocol for a randomized control trial. Trials. 2020;21(1):722.
doi: 10.1186/s13063-020-04642-2 pubmed: 32807214 pmcid: 7429934
World Health Organisation. Plague Outbreak Toolbox 2021. Available from: https://www.who.int/emergencies/outbreak-toolkit/disease-outbreak-toolboxes/plague-outbreak-toolbox .
Bourner J, Randriamparany R, Rasoanaivo TF, Denis E, Randremanana RV, Vaillant M, et al. Bubonic plague: can the size of buboes be accurately and consistently measured with a digital calliper? Trials. 2023;24(1):815.
doi: 10.1186/s13063-023-07835-7 pubmed: 38115024 pmcid: 10729355

Auteurs

Rindra Vatosoa Randremanana (RV)

Institut Pasteur de Madagascar, Antananarivo, Madagascar.

Mihaja Raberahona (M)

Centre d'Infectiologie Charles Mérieux, University of Antananarivo, Antananarivo, Madagascar.
Department of Infectious Diseases, University Hospital Joseph Raseta Befelatanana, Antananarivo, Madagascar.

Mamy Jean de Dieu Randria (MJ)

Department of Infectious Diseases, University Hospital Joseph Raseta Befelatanana, Antananarivo, Madagascar.
Faculty of Medicine, University of Antananarivo, Antananarivo, Madagascar.

Josephine Bourner (J)

ISARIC, Pandemic Sciences Institute, University of Oxford, Oxford, UK. josephine.bourner@ndm.ox.ac.uk.
ORCID: 0000-0003-4687-8380

Gabriella Zadonirina (G)

Institut Pasteur de Madagascar, Antananarivo, Madagascar.

Hanitra Razananaivo (H)

Institut Pasteur de Madagascar, Antananarivo, Madagascar.

Théodora Mayouya-Gamana (T)

Institut Pasteur de Madagascar, Antananarivo, Madagascar.

Reziky Mangahasimbola (R)

Institut Pasteur de Madagascar, Antananarivo, Madagascar.

Elise Pesonel (E)

ISARIC, Pandemic Sciences Institute, University of Oxford, Oxford, UK.

Annelies Gillesen (A)

ISARIC, Pandemic Sciences Institute, University of Oxford, Oxford, UK.

Minoarisoa Rajerison (M)

Institut Pasteur de Madagascar, Antananarivo, Madagascar.

Voahangy Andrianaivoarimanana (V)

Institut Pasteur de Madagascar, Antananarivo, Madagascar.

Tansy Edwards (T)

London School of Hygiene and Tropical Medicine, London, UK.

Peter Horby (P)

ISARIC, Pandemic Sciences Institute, University of Oxford, Oxford, UK.

Piero Olliaro (P)

ISARIC, Pandemic Sciences Institute, University of Oxford, Oxford, UK.

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Classifications MeSH

questionsmedicales.fr › Composés hétérocycliques › Composés hétérocycliques à cycles fusionnés › Composés hétérobicycliques › Quinoléines › Quinolinone › Fluoroquinolones › Ciprofloxacine › An open-label, randomized, non-inferiority...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › An open-label, randomized, non-inferiority...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › An open-label, randomized, non-inferiority...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Anti-infectieux › Antibactériens › An open-label, randomized, non-inferiority...
questionsmedicales.fr › Infection › Maladies vectorielles › Peste › An open-label, randomized, non-inferiority...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › An open-label, randomized, non-inferiority...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › Essais d'équivalence comme sujet › An open-label, randomized, non-inferiority...
questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Association de médicaments › An open-label, randomized, non-inferiority...
questionsmedicales.fr › Eucaryotes › Animaux › An open-label, randomized, non-inferiority...
questionsmedicales.fr › Glucides › Hétérosides › Aminosides › An open-label, randomized, non-inferiority...