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Optimisation of treatments for oral Neisseria gonorrhoeae infection : Pharmacokinetics Study (STI-PK project) - study protocol for non-randomised clinical trial

Kong, Fabian Y. S. (författare)
Centre for Epidemiology and Biostatistics, School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia
Unemo, Magnus, 1970- (författare)
Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,WHO Collaborating Centre for Gonorrhoea and Other STIs, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine, Microbiology, Örebro University, Örebro, Sweden; Institute for Global Health, University College London, London, UK
Lim, Shueh H. (författare)
Centre for Epidemiology and Biostatistics, School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia; The Crane General Practice, Melbourne, Victoria, Australia
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Latch, Ngaire (författare)
Centre for Epidemiology and Biostatistics, School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia
Williamson, Deborah A. (författare)
Department of Infectious Diseases, The Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne, Victoria, Australia; Walter and Eliza Hall Institute of Medical Research, Melbourne, Victoria, Australia; Victorian Infectious Diseases Reference Laboratory, Melbourne, Victoria, Australia
Roberts, Jason A. (författare)
The University of Queensland Centre for Clinical Research, Brisbane, Queensland, Australia; Departments of Pharmacy and Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia; Herston Infectious Diseases Institute, Metro North Health, Brisbane, Queensland, Australia; Division of Anaesthesiology Critical Care Emergency and Pain Medicine, Nîmes University Hospital, University of Montpellier, Nîmes, France
Wallis, Steven C. (författare)
The University of Queensland Centre for Clinical Research, Brisbane, Queensland, Australia
Parker, Suzanne L. (författare)
The University of Queensland Centre for Clinical Research, Brisbane, Queensland, Australia
Landersdorfer, Cornelia B. (författare)
Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia
Yap, Tami (författare)
Melbourne Dental School, The University of Melbourne, Melbourne, Victoria, Australia
Fairley, Christopher K. (författare)
Melbourne Sexual Health Centre, Alfred Health, Carlton, Victoria, Australia; Central Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Victoria, Australia
Chow, Eric P. F. (författare)
Melbourne Sexual Health Centre, Alfred Health, Carlton, Victoria, Australia; Central Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Victoria, Australia
Lewis, David A. (författare)
Westmead Clinical School and Sydney Institute for Infectious Diseases, The University of Sydney, Sydney, New South Wales, Australia; Western Sydney Sexual Health Centre, Western Sydney Local Health District, Parramatta, New South Wales, Australia
Hammoud, Mohamed A. (författare)
Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia
Hocking, Jane S. (författare)
Centre for Epidemiology and Biostatistics, School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia
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 (creator_code:org_t)
2022-11-11
2022
Engelska.
Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 12:11
Relaterad länk:
https://doi.org/10.1...
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https://urn.kb.se/re...
https://doi.org/10.1...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • INTRODUCTION: Neisseria gonorrhoeae infections are common and incidence increasing. Oropharyngeal infections are associated with greater treatment failure compared with other sites and drive transmission to anogenital sites through saliva. Gonococcal resistance is increasing and new treatments are scarce, therefore, clinicians must optimise currently available and emerging treatments in order to have efficacious therapeutic options. This requires pharmacokinetic data from the oral cavity/oropharynx, however, availability of such information is currently limited.METHODS AND ANALYSIS: Healthy male volunteers (participants) recruited into the study will receive single doses of either ceftriaxone 1 g, cefixime 400 mg or ceftriaxone 500 mg plus 2 g azithromycin. Participants will provide samples at 6-8 time points (treatment regimen dependent) from four oral sites, two oral fluids, one anorectal swab and blood. Participants will complete online questionnaires about their medical history, sexual practices and any side effects experienced up to days 5-7. Saliva/oral mucosal pH and oral microbiome analysis will be undertaken. Bioanalysis will be conducted by liquid chromatography-mass spectrometry. Drug concentrations over time will be used to develop mathematical models for optimisation of drug dosing regimens and to estimate pharmacodynamic targets of efficacy.ETHICS AND DISSEMINATION: This study was approved by Royal Melbourne Hospital Human Research Ethics Committee (60370/MH-2021). The study results will be submitted for publication in peer-reviewed journals and reported at conferences. Summary results will be sent to participants requesting them. All data relevant to the study will be included in the article or uploaded as supplementary information.TRIAL REGISTRATION NUMBER: ACTRN12621000339853.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Infectious Medicine (hsv//eng)

Nyckelord

CLINICAL PHARMACOLOGY
INFECTIOUS DISEASES
SEXUAL MEDICINE

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