Evidence map›Paper›PMID 32807214›Full record

ArticleTrials2020

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.

Rindra Vatosoa Randremanana, Mihaja Raberahona, Mamy Jean de Dieu Randria, Minoarisoa Rajerison, Voahangy Andrianaivoarimanana, Agathe Legrand, Tsinjo Fehizoro Rasoanaivo, Ravaka Randriamparany, Théodora Mayouya-Gamana, Reziky Mangahasimbola and 8 more

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

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04110340 (An Open-label, Randomised, Non-inferiority Trial of the Efficacy and Safety of Ciprofloxacin Versus an Aminoglycoside Followed by Ciprofloxacin in the Treatment of Bubonic Plague), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 12% 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.

NCT04110340 phase3completednot on this map

An Open-label, Randomised, Non-inferiority Trial of the Efficacy and Safety of Ciprofloxacin Versus an Aminoglycoside Followed by Ciprofloxacin in the Treatment of Bubonic Plague

TypeinterventionalSponsorUniversity of OxfordRan2020 to 2025Enrolled222ConditionsPlague, Bubonic, Plague, PneumonicArmsCiprofloxacin, Streptomycin, Gentamicin
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Transmission of Antimicrobial Resistant Yersinia pestis During a Pneumonic Plague Outbreak.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Article
  8. Article
  9. Article
  10. Article
  11. 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

18 authors at 4 institutions in 2 countries.

Rindra Vatosoa RandremananaInstitut Pasteur de Madagascar, Antananarivo, Madagascar.
Mihaja RaberahonaInfectious Diseases Department, University Hospital Joseph Raseta Befelatanana Antananarivo - Centre d'Infectiologie Charles Mérieux, University of Antananarivo, Antananarivo, Madagascar.
Mamy Jean de Dieu RandriaInfectious Diseases Department, University Hospital Joseph Raseta, Antananarivo, Madagascar.
Minoarisoa RajerisonInstitut Pasteur de Madagascar, Antananarivo, Madagascar.
Voahangy AndrianaivoarimananaInstitut Pasteur de Madagascar, Antananarivo, Madagascar.
Agathe LegrandInstitut Pasteur de Madagascar, Antananarivo, Madagascar.
Tsinjo Fehizoro RasoanaivoInstitut Pasteur de Madagascar, Antananarivo, Madagascar.
Ravaka RandriamparanyInstitut Pasteur de Madagascar, Antananarivo, Madagascar.
Théodora Mayouya-GamanaInstitut Pasteur de Madagascar, Antananarivo, Madagascar.
Reziky MangahasimbolaInstitut Pasteur de Madagascar, Antananarivo, Madagascar.
Josie BournerUniversity of Oxford, Oxford, UK. josephine.bourner@ndm.ox.ac.uk.ORCID http://orcid.org/0000-0003-4687-8380
Alex SalamUniversity of Oxford, Oxford, UK.
Annelies GillesenUniversity of Oxford, Oxford, UK.
Tansy EdwardsLondon School of Hygiene and Tropical Medicine, London, UK.
Matthieu SchoenhalsInstitut Pasteur de Madagascar, Antananarivo, Madagascar.
Laurence BarilInstitut Pasteur de Madagascar, Antananarivo, Madagascar.
Peter HorbyUniversity of Oxford, Oxford, UK.
Piero OlliaroUniversity of Oxford, Oxford, UK.
Institut Pasteur de Madagascar · MGUniversity of Oxford · GBLondon School of Hygiene & Tropical Medicine · GBUniversity of Antananarivo · MG

Funding

Department for International Development 216273_Z_19_ZWellcome TrustWellcome Trust 216273_Z_19_Z
6 · The paper itself

Abstract

backgroundBubonic 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.

methodsA 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 registrationClinicalTrials.gov NCT04110340 . Registered on 1 October 2019.

Indexed as

PlagueCiprofloxacinEquivalence Trials as TopicFemaleHumansMadagascarMaleStreptomycinYersinia pestisCiprofloxacinStreptomycinBubonic plagueCiprofloxacinPlaguePneumonic plagueStreptomycin

Identifiers

PMID32807214
PMCPMC7429934
OpenAlexW3049616002

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.