SAFETY OF ANTIMALARIALS IN THE FIRST TRIMESTER: AN ADAPTIVE PLATFORM TRIAL

Informazioni relative al progetto

SAFIRE

ID dell’accordo di sovvenzione: 101145740

DOI

10.3030/101145740

Data della firma CE 11 Marzo 2024

Data di avvio 1 Giugno 2024

Data di completamento 30 Novembre 2028

Finanziato da

• Health

Costo totale

€ 5 191 431,44

Contributo UE

€ 5 191 431,44

Coordinato da

STICHTING AMSTERDAM UMC
Netherlands

CORDIS fornisce collegamenti ai risultati finali pubblici e alle pubblicazioni dei progetti ORIZZONTE.

I link ai risultati e alle pubblicazioni dei progetti del 7° PQ, così come i link ad alcuni tipi di risultati specifici come dataset e software, sono recuperati dinamicamente da .OpenAIRE .

Risultati finali

Documents, reports (14)

Study initiation package

Before enrolment of the first study participant Registration number of the clinical study in a registry meeting WHO criteriaFinal version of the study protocol as approved by the regulator(s) / ethics committee(s)Regulatory and ethics (if applicable, institutional) approvals required for the enrolment of the first study participant (in case of multicentre celinical studies, submission of approvals for the first clinical site is sufficient).

Trial Information, Education and communication toolkit

Final version of education and communication toolkits validated by PMC for the clinical trial

Trial progress monitoring plan

Study progress plan with projected dates- Project Gantt chart reviewed at PMC monthly meetings

Consortium internal communication strategy

Plan describing how the internal communication within the consortium will take place

Site audit plan

Audit plan developed

External advisory committees charter

Charter for DSMB

Clinical Monitoring Plan and quality assurance

Monitoring plan to be provided by a CRO

Report on centralized training

Report on the centralised training to build the necessary capacity and standards for carrying out the research studies.

Plan for the exploitation and dissemination of results including communication activities

Plan for communication, exploitation and dissemination plan validated by the consortium’s members

RT Delphi survey report

RT Delphi survey report on consensus for the primary endpoint(s), effect size and non-inferiority margin and stopping rules

Statistical Analysis Plan

Plan for all data analysis to be performed signed by DSMB

Training programme based on needs assessment

Detailed training programme Training plan developed based on the needs assessment.

Investigator’s brochure

To give more details on the drug to be used by the trial

PK Analysis plan and Master Transfer Agreement

Plan for PK samples transfer and PK analysis to be performed

Other (2)

Registration of Clinical trial

Registration of the clinical trail in an open access WHO approved repository.

Trial statistical design document

Summary report of statistical design considerations, trial alternatives, trial operating characteristics, and decision criteria

Websites, patent fillings, videos etc. (1)

Project webpage

A website with a project overview and consortium

Data Management Plan (2)

Updated data management plan

Plan for data management and data sharing - revised draft v2-0

Data management plan

Plan for data management and data sharing v-1

Pubblicazioni

Peer reviewed articles (1)

Development of Context-Appropriate Recruitment and Retention Approaches for Pregnant Women in the SAFIRE Clinical Trial Assessing Safety and Efficacy of Artemisinin-Combination Therapies: A Formative Research Protocol

Autori: Jenna Hoyt, Adélaïde Compaoré, Samba Diarra, Freddy Bikioli Bolombo, Susan Nayiga, Serge Henri Zango, Moussa Djimde, Stephanie Dellicour, Japhet Kabalu Tshiongo, Hypolite Muhindo-Mavoko, Abel Kakuru, Simon Kariuki, Hellen Barsosio, Kassoum Kayentao, Innocent Valea, Jenny Hill, Maud Majeres Lugand
Pubblicato in: International Journal of Qualitative Methods, Numero 25, 2026, ISSN 1609-4069
Editore: SAGE Publications
DOI: 10.1177/16094069261449007