IVM-LICE Page 1 of 26 Version 1.0 16/05/17 A Pilot study evaluating whether treatment of scabies with ivermectin also treats headlice Ivermectin IVM-LICE ISRCTN NCT (clinicaltrials.gov) V1.0 16 th May 2017 SPONSOR: London School of Hygiene & Tropical Medicine FUNDERS: Wellcome Trust STUDY COORDINATION CENTRE: LSHTM LSHTM ethics reference: Pending
26
Embed
A Pilot study evaluating whether treatment of scabies with ... · ivermectin tablets have been distributed for both onchocerciasis and lymphatic filariasis. Several Several studies
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
LondonSchoolofHygiene&TropicalMedicine is themainresearchsponsor forthisstudy. For furtherinformationregardingthesponsorshipconditions,pleasecontacttheResearchGovernanceandIntegrityOffice:
FunderThisstudyisfundedaspartofaWellcomeTrustResearchFellowshipheldbyMichaelMarks.This protocol describes the IVM-LICE study andprovides information about procedures for enteringparticipants.The protocol should not be used as a guide for the treatment of other participants; every care was taken in itsdrafting,butcorrectionsoramendmentsmaybenecessary.Thesewillbecirculatedtoinvestigatorsinthestudy,butcentresenteringparticipantsforthefirsttimeareadvisedtocontactthetrialscentretoconfirmtheyhavethemostrecentversion.
This trial will adhere to the principles outlined in the International Conference on Harmonisation Good ClinicalPractice(ICHGCP)guidelines,protocolandallapplicablelocalregulations.
Anyuntowardmedicaloccurrenceinaparticipanttowhomamedicinalproducthasbeenadministered, includingoccurrenceswhicharenotnecessarilycausedbyorrelatedtothatproduct.An AE can therefore be any unfavourable and unintended sign (including anabnormal laboratory finding), symptom, or disease temporally associatedwiththeuseofaninvestigationalmedicinalproduct(IMP),whetherornotconsideredrelatedtotheIMP.
Adverse Reaction(AR)
Any untoward and unintended response in a participant to an investigationalmedicinalproductwhichisrelatedtoanydoseadministeredtothatparticipant.The phrase “response to an investigational medicinal product” means that acausalrelationshipbetweenatrialmedicationandanAEisatleastareasonablepossibility,i.e.therelationshipcannotberuledout.All cases judgedbyeither the reportingmedicallyqualifiedprofessionalor theSponsor as having a reasonable suspected causal relationship to the trialmedicationqualifyasadversereactions.
Serious AdverseEvent(SAE)
Aseriousadverseeventisanyuntowardmedicaloccurrencethat:• Resultsindeath• Islife-threatening• Requiresinpatienthospitalisationorprolongationofexistinghospitalisation• Resultsinpersistentorsignificantdisability/incapacity• ConsistsofacongenitalanomalyorbirthdefectOther ‘important medical events’ may also be considered serious if theyjeopardisetheparticipantorrequireaninterventiontopreventoneoftheaboveconsequences.
Serious AdverseReaction(SAR)
An adverse event that is both serious and, in the opinion of the reportinginvestigator, believedwith reasonable probability to be due to one of the trialtreatments,basedontheinformationprovided.
SuspectedUnexpectedSerious AdverseReaction(SUSAR)
A serious adverse reaction, the nature and severity of which is not consistentwiththeinformationaboutthemedicinalproductinquestionsetout:• In the caseof aproductwith amarketingauthorisation, in the summaryofproductcharacteristics(SmPC)forthatproduct
6.2 CAUSALITYMostadverseeventsandadversedrugreactionsthatoccurinthisstudy,whethertheyareseriousornot,will be expected treatment-related side effects due to thedrugsused in this study. The assignment ofcausality should be made by the investigator responsible for the care of the participant using thedefinitionsinthetablebelow.Ifanydoubtaboutthecausalityexiststhelocalinvestigatorshouldinformthestudycoordinationcentrewhowill notify theChief Investigators. Thepharmaceutical companies and/orother cliniciansmaybeaskedtoadviseinsomecases.
Possible Thereissomeevidencetosuggestacausalrelationship(e.g.becausetheeventoccurswithinareasonabletimeafteradministrationofthetrialmedication).However,theinfluenceofotherfactorsmayhavecontributedtotheevent(e.g.theparticipant’sclinicalcondition,otherconcomitanttreatments).
6.3 REPORTINGPROCEDURESDependingonthenatureoftheeventthereportingproceduresbelowshouldbefollowed.Anyquestionsconcerning adverse event reporting should be directed to the study coordination centre in the firstinstance.6.3.1NonseriousAdverseReactions(ARs)/AdverseEvents(AEs)GiventheestablishedsafetyprofileofthedrugsbeingusedinthisstudyandthefactthattheyarebeingusedforestablishedindicationswewillonlycollectdataonSAEsandSUSARs.6.3.2SeriousAdverseReactions(SARs)/SeriousAdverseEvents(SAEs)Serious Adverse Events (SAEs) and Serious Adverse Reactions (SARs) should be reported to the studycoordinationcentrewithin24hoursofthelocalsitebeingmadeawareoftheevent.AnSAEformshouldbecompletedandsubmittedtothestudycoordinationcentrewithasmuchdetailofthe event that is available at that time. If awaiting further details, a follow up SAE report should besubmittedpromptlyuponreceiptofanyoutstandinginformation. TheCI(forasingle-centretrial)orPI(for a multi-centre trial) must record the event with an assessment of seriousness, causality andexpectedness.Anyeventsrelatingtoapre-existingconditionoranyplannedhospitalisationsforelectivetreatmentofapre-existingconditiondonotneedreportingasSAEs.6.3.3SUSARsAllSAEsassignedbythePIordelegateasbothsuspectedtoberelatedtoIMP-treatmentandunexpectedwillbeclassifiedasSUSARsandwillbesubjecttoexpeditedreportingtotheRegulatoryAuthority,intheUK: Medicines and Healthcare Products Regulatory Agency (MHRA). The Sponsor (or delegate) willinform the MHRA, and the ethics committee of UK-relevant SUSARs within the required expeditedreportingtimescales(asperLSHTMStandardOperatingProcedureforrecording,managingandreportingofadverseeventsforIMPstudies).Forblindedtrials,allSUSARsmustbereportedassumingtheactivecompoundisinvolved.Inthecaseofasuspected,unexpected,seriousadversereactions(SUSAR),thestaffatthesiteshould:
IVM-LICE Page 18 of 26 Version 1.0 16/05/17
1. Contactthestudycoordinationcentreimmediatelybyphoneoremailtoinformthemoftheevent.2. Submit a completed SAE form (signed and dated) within 24 hours, together with relevant
10. REGULATORYISSUES10.1 ETHICSAPPROVALThe Study Coordination Centre has applied for ethics approval from the LSHTM Research EthicsCommittee,aswellastheSolomonIslandsNationalEthicsBoardandtheAtoifiAdventistHospitalEthicsCommittee.Substantialprotocolamendmentswillnotbe implementeduntil a favourableopinionhasbeengrantedfromboththeethicscommittee.Correspondencefrombothethicscommitteeswillbemaintainedinthetrialmasterfile.Asthedurationofthestudyis3monthstheannualprogressreportwillaccompanythenotificationoftheendofthestudy.10.2 CONSENTANDCONFIDENTIALITYPriortoperforminganystudyspecificprocedure,writteninformedconsentwillbeobtainedforeachsubject.Informationsheetsexplainingthestudywillbedistributedtocommunitynurseswhowillbetrainedinexplainingthestudy.Forsubjectsbelowthelegalage,aparentorlegalguardianmustprovideconsent.Writtenconsentwillbeobtainedinlocaldialectonalloccasions.10.3 ConfidentialityAlldatawillbefully-anonymised.AcopyofthedatabasewillbeheldbothatAtoifiHospitalandLSHTM.Thestudydatabasewillnotcontainanypatientidentifiableinformation.FormswillberetainedatAtoifiAdventistHospital.10.4 INDEMNITYLondonSchoolofHygiene&TropicalMedicineholdsPublicLiability("negligentharm")andClinicalTrial("non-negligentharm")insurancepolicieswhichapplytothistrial.10.5 SPONSORLondon School of Hygiene& TropicalMedicinewill act as themain sponsor for this study. Delegatedresponsibilitieswillbeassignedlocally.10.6 FUNDINGThisstudyisfundedaspartofaWellcomeTrustResearchFellowshipheldbyMichaelMarks.Nopaymentswillbemadetopatientsparticipatinginthisstudy.10.7 AUDITSANDINSPECTIONSThestudymaybesubjectauditbytheLondonSchoolofHygiene&TropicalMedicineundertheirremitassponsor,theStudyCoordinationCentreandotherregulatorybodiestoensureadherencetoGCP.
IVM-LICE Page 23 of 26 Version 1.0 16/05/17
11. TRIALMANAGEMENTATrialManagementGroup(TMG)willbeappointedandwillberesponsibleforoverseeingtheprogressofthetrial.Theday-to-daymanagementofthetrialwillbeco-ordinatedbyMichaelMarksandJasonDiau.All treatments in the study are being given for standard indications and the drugs have known safetyprofilesincludinginthesettingofco-administration.ADSMBwillthereforenotbeappointed.AlldatawillbeheldjointlybyLSHTMandAAH.DatawillbestoredonanencryptedpasswordprotectedserveratbothLSHTMandAAH.
IVM-LICE Page 24 of 26 Version 1.0 16/05/17
12. PUBLICATIONPOLICYAllpublicationsandpresentationsrelatingtothestudywillbeauthorisedbytheTrialManagementGroup.ThefirstpublicationofthetrialresultswillbeinthenameoftheTrialManagementGroup,ifthisdoesnotconflictwiththe journal’spolicy. If therearenamedauthors, thesewill includeat least thetrial’sChiefInvestigator,StatisticianandTrialCoordinator.MembersoftheTMGandtheDataMonitoringCommitteewillbelistedandcontributorswillbecitedbynameifpublishedinajournalwherethisdoesnotconflictwiththejournal’spolicy.AuthorshipofparallelstudiesinitiatedoutsideoftheTrialManagementGroupwillbeaccordingtotheindividualsinvolvedintheprojectbutmustacknowledgethecontributionoftheTrialManagementGroupandtheStudyCoordinationCentre.