About: 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

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About: 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 Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	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
Creator	Horby, Peter Baril, Laurence Edwards, Tansy Raberahona, Mihaja Olliaro, Piero Randremanana, Rindra Andrianaivoarimanana, Voahangy Bourner, Josie Fehizoro, Tsinjo Gillesen, Annelies Jean De Dieu Randria, Mamy Legrand, Agathe Mangahasimbola, Reziky Mayouya-Gamana, Théodora Rajerison, Minoarisoa Randriamparany, Ravaka Salam, Alex Schoenhals, Matthieu
Source	PMC
abstract	BACKGROUND: Bubonic plague is the primary manifestation of infection with Yersinia pestis, accounting for 90% of all plague cases and with 75% of global cases reported in Madagascar. All drugs in use for treating plague are registered based on experimental data and anecdotal evidence, and no regimen currently recommended is supported by a randomized clinical trial. The IMASOY trial intends to fill this knowledge gap by comparing two 10-day regimens included in the national guidelines in Madagascar. The primary objective of the trial is to test the hypothesis that ciprofloxacin monotherapy is non-inferior to streptomycin followed by ciprofloxacin for the treatment of bubonic plague, thus avoiding the need for injectable, potentially toxic, aminoglycosides. METHODS: A two-arm parallel-group randomized control trial will be conducted across peripheral health centres in Madagascar in five districts. Males and non-pregnant females of all ages with suspected bubonic or pneumonic plague will be recruited over the course of three plague ‘seasons’. The primary endpoint of the trial is to assess the proportion of patients with bubonic plague who have a therapeutic response to treatment (defined as alive, resolution of fever, 25% reduction in the size of measurable buboes, has not received an alternative treatment and no clinical decision to continue antibiotics) as assessed on day 11. DISCUSSION: If successful, the trial has the potential to inform the standard of care guidelines not just in Madagascar but in other countries afflicted by plague. The trial is currently ongoing and expected to complete recruitment in 2022. TRIAL REGISTRATION: ClinicalTrials.gov NCT04110340. Registered on 1 October 2019
has issue date	2020-08-17(xsd:dateTime)
bibo:doi	10.1186/s13063-020-04642-2
has license	cc-by
sha1sum (hex)	cec48f31797ef2c7dde2eee8426a985687a09684
schema:url	https://doi.org/10.1186/s13063-020-04642-2
resource representing a document's title	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
has PubMed Central identifier	PMC7429934
schema:publication	Trials
resource representing a document's body	covid:cec48f31797ef2c7dde2eee8426a985687a09684#body_text
is schema:about of	named entity 'fever' named entity 'Madagascar' named entity 'supported' named entity 'size' named entity 'afflicted' named entity 'pneumonic plague' named entity 'monotherapy' named entity 'ciprofloxacin' named entity 'REGIMEN' named entity 'MALES' named entity 'EXPERIMENTAL DATA' named entity 'CIPROFLOXACIN' named entity 'ANTIBIOTICS' named entity 'RECRUITMENT' named entity 'INFERIOR' named entity 'ACROSS' named entity 'ONGOING' named entity 'DAY' named entity 'CASES' named entity 'COMPLETE' named entity 'ASSESS' named entity 'TO INFORM' named entity 'ciprofloxacin' named entity 'ongoing' named entity 'assessed' named entity 'All' named entity 'suspected' named entity 'randomized control trial' named entity 'alternative treatment' named entity 'randomized control trial' named entity 'Bubonic plague' named entity 'Madagascar' named entity 'standard of care' named entity 'pneumonic plague' named entity 'randomized clinical trial' named entity 'ciprofloxacin' named entity 'ciprofloxacin' named entity 'open-label' named entity 'study protocol' named entity 'Madagascar' named entity 'ciprofloxacin' named entity 'intravenous therapy' named entity 'septicaemia' named entity 'University of Oxford' named entity 'DSMB' named entity 'septicaemic plague' named entity 'Yersinia pestis' named entity 'Y. pestis' named entity 'Pneumonic plague' named entity 'streptomycin' named entity 'adverse event' named entity 'bubonic plague' named entity 'adverse events' named entity 'principal investigator' named entity 'antibody' named entity 'plague endemic' named entity 'caf-1' named entity 'ciprofloxacin' named entity 'quality assurance' named entity 'oral medications' named entity 'RDT' named entity 'streptomycin' named entity 'monotherapy' named entity 'plague' named entity 'qPCR' named entity 'risk difference'

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