Holm, Mona Katrine Alberthe http://orcid.org/0000-0003-2233-0062
Meiniche, Heidi Karin
Pedersen, Michael
Eriksen, Helle Brander
Westh, Henrik
Holzknecht, Barbara J.
Bartels, Mette Damkjær
Funding for this research was provided by:
Hvidovre Hospital (AHH forskningspulje 2019 - frie midler, Direktionen)
Christian Larsen og Dommer Ellen Larsens legat
Lizzie og Mogens Staal Fonden
Aase og Ejnar Danielsens Fond
Else og Mogens Wedell Wedellsborgs Fond
Thora og Viggo Groves Mindelegat
Article History
Received: 22 January 2022
Accepted: 31 May 2022
First Online: 16 June 2022
Declarations
:
: To continue prescribing clindamycin for healthy MRSA carriers, we anticipate finding an increase in treatment success ≥ 30% in the treatment arm receiving clindamycin compared with the treatment arm receiving placebo. Participants consuming placebo in the trial also receive an active treatment in terms of mupirocin nasal ointment and chlorhexidine wash and will be advised to follow the usual guidelines regarding the cleaning of home. The use of placebo in the trial is justified to reduce bias when comparing the results between the two groups.Acceptance and approval of this study protocol, version 7 {3}, was obtained by the Regional Research Ethical Committee on June 6, 2020, registered with number H-19062898 {24}. Approval of the clinical trial was given by the Danish Medicines Agency on September 30, 2019, and by the data protection agency on October 21, 2019, with registration number P-2019-621. Furthermore, the study is conducted according to ICH-GCP (guidelines for Good Clinical Practice) and monitored and inspected by the Copenhagen GCP units {21a}, including continuous regular audits as frequently as requested by the GCP-unit, based on the inclusion of participants, as well as checking recruitment, training of staff, and data quality {23}, in accordance with the ethical principles, in the Declaration of Helsinki, as well as all applicable local regulatory requirements. The study will also be conducted in accordance with the GDPR and national legislation and has been registered at ExternalRef removed with EudraCT number: 2019-002631-29.If there is a sudden need for change in, e.g., grant givers, eligibility criteria, or protocol modifications, the ethics committee will be notified and asked for acceptance {25}. There are no plans for future studies using the data {26b}.
: Not applicable
: The authors declare that they have no competing interests.