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

Rindra Vatosoa Randremanana; Mihaja Raberahona; Mamy Jean de Dieu Randria; Josephine Bourner; Gabriella Zadonirina; Hanitra Razananaivo; Théodora Mayouya-Gamana; Reziky Mangahasimbola; Elise Pesonel; Annelies Gillesen; Minoarisoa Rajerison; Voahangy Andrianaivoarimanana; Tansy Edwards; Peter Horby; Piero Olliaro

doi:10.1186/s13063-024-08302-7

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

Trials. 2024 Jul 5;25(1):457. doi: 10.1186/s13063-024-08302-7.

Authors

Rindra Vatosoa Randremanana¹, Mihaja Raberahona^{2

3}, Mamy Jean de Dieu Randria^{3

4}, Josephine Bourner⁵, Gabriella Zadonirina¹, Hanitra Razananaivo¹, Théodora Mayouya-Gamana¹, Reziky Mangahasimbola¹, Elise Pesonel⁶, Annelies Gillesen⁶, Minoarisoa Rajerison¹, Voahangy Andrianaivoarimanana¹, Tansy Edwards⁷, Peter Horby⁶, Piero Olliaro⁶

Affiliations

¹ Institut Pasteur de Madagascar, Antananarivo, Madagascar.
² Centre d'Infectiologie Charles Mérieux, University of Antananarivo, Antananarivo, Madagascar.
³ Department of Infectious Diseases, University Hospital Joseph Raseta Befelatanana, Antananarivo, Madagascar.
⁴ Faculty of Medicine, University of Antananarivo, Antananarivo, Madagascar.
⁵ ISARIC, Pandemic Sciences Institute, University of Oxford, Oxford, UK. [email protected].
⁶ ISARIC, Pandemic Sciences Institute, University of Oxford, Oxford, UK.
⁷ London School of Hygiene and Tropical Medicine, London, UK.

Abstract

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

Publication types

Clinical Trial Protocol

MeSH terms

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

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

Authors

Affiliations

Abstract

Publication types

MeSH terms

Substances

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