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- Kong, Fabian Y. S., et al.
(författare)
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Optimisation of treatments for oral Neisseria gonorrhoeae infection : Pharmacokinetics Study (STI-PK project) - study protocol for non-randomised clinical trial
- 2022
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Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 12:11
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 3. |
- Parker, W. A. E., et al.
(författare)
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Prevalence of microspirometry-defined chronic obstructive pulmonary disease in two European cohorts of patients with significant smoking history hospitalised for acute myocardial infarction
- 2023
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Ingår i: Thorax. - : BMJ Publishing Group Ltd. - 0040-6376 .- 1468-3296. ; 78:Suppl. 4, s. A66-A66
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Introduction: Smoking is a major risk factor for both chronic obstructive pulmonary disease (COPD) and myocardial infarction (MI). Systemic inflammation also contributes to both diseases and has been suggested as a potential target for intervention. Prevalence of COPD in those with a significant smoking history hospitalised for MI has not been well-characterised. We sought to obtain an accurate estimate of COPD burden in this group and characterise the population.Methods: Two consecutive cohorts of patients hospitalised for MI with a smoking history of ≥10 pack-years were recruited in Sweden and the United Kingdom (UK). Baseline characteristics were recorded, including treatment with inhaled corticosteroids (ICS) and eosinophil count in blood. Microspirometry was performed using the Vitalograph COPD-6 device and symptom burden assessed using the COPD Assessment Test (CAT). The primary outcome was the prevalence of a preliminary diagnosis of clinically-significant COPD, here defined as a ratio of forced expiratory volume in 1 and 6 seconds (FEV1/FEV6) <0.7 and with FEV1 <80% of predicted value.Results: In the UK cohort, 216 participants with MI (26% female, median age 60 (IQR 53–67) years, smoking history 32 (23–45) pack-years) were recruited. The proportion with any COPD was 36%. Clinically-significant COPD was found in 30 participants (13.9%, 95% CI 9.5–19.2). Of these, 43% had a prior COPD diagnosis, 20% had an eosinophil count ≥300 cells/mm3, mean CAT score was 14.4 ± 9.3), 80% had high symptom burden (CAT score >10) and 23% were receiving ICS. The Swedish cohort included 302 participants with MI (24% female, median age 68 (IQR 61–76) years, 26 (15–38) pack years), and clinically-significant COPD was found in 52 (17.2%; 12.9–21.5). In these 52 participants, 17% had a prior COPD diagnosis, 20% had an eosinophil count ≥300 cells/mm3, mean CAT score was 12.9 ± 7.2, 63% had CAT score ≥10 and 15% had treatment with ICS.Conclusions: The prevalence of preliminary diagnosis of clinically-significant COPD in patients with a ≥10 pack-year smoking history hospitalised for MI is similar between two European cohorts and under-recognised. Further work is warranted to determine whether identification and treatment of COPD improves clinical outcomes following MI.
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