主要研究目的研究空腹和餐后状态下单次口服受试制剂头孢地尼干混悬剂（规格：250mg/5ml，广东万泰科创药业有限公司提供）与参比制剂头孢地尼干混悬剂（规格：250mg/5ml，持证商：Aurobindo Pharma Limited），在健康成年受试者体内的药代动力学，评价空腹和餐后口服两种制剂的生物等效性。次要研究目的评价中国健康受试者空腹和餐后状态下，单次口服受试制剂头孢地尼干混悬剂和参比制剂头孢地尼干混悬剂后的安全性。

开始日期2024-09-29

申办/合作机构

广东万泰科创药业有限公司

CTR20242859 / CompletedN/A

头孢地尼干混悬剂在健康受试者中单中心、随机、开放、两制剂、单次给药、两周期、双交叉空腹/餐后生物等效性试验研究方案

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂头孢地尼干混悬剂（生产厂家：苏州第三制药厂有限责任公司）与参比制剂头孢地尼干混悬剂（持证商：Aurobindo Pharma Limited）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。

开始日期2024-09-10

申办/合作机构

苏州第三制药厂有限责任公司

CTR20241322 / CompletedN/A

中国健康受试者空腹和餐后单次口服头孢地尼干混悬剂的随机、开放、两序列、两周期、双交叉设计的生物等效性试验

主要研究目的研究空腹和餐后状态下单次口服受试制剂头孢地尼干混悬剂（规格：250mg/5ml，广东金城金素制药有限公司提供）与参比制剂头孢地尼干混悬剂（规格：250mg/5ml，持证商：Aurobindo Pharma Limited），在健康成年受试者体内的药代动力学，评价空腹和餐后口服两种制剂的生物等效性。次要研究目的评价中国健康受试者空腹和餐后状态下，单次口服受试制剂头孢地尼干混悬剂和参比制剂头孢地尼干混悬剂后的安全性。

开始日期2024-05-06

申办/合作机构

广东金城金素制药有限公司

100 项与细菌性中耳炎相关的临床结果

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100 项与细菌性中耳炎相关的转化医学

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0 项与细菌性中耳炎相关的专利（医药）

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179

项与细菌性中耳炎相关的文献（医药）

2024-11-01·Microbial Pathogenesis

Antimicrobial and antibiofilm effect of promethazine on bacterial isolates from canine otitis externa: an in vitro study

Article

作者: Cordeiro, Rossana de Aguiar ; Sidrim, José Júlio Costa ; Medeiros Guedes, Rodrigo Fonseca de ; Guedes, Rodrigo Fonseca de Medeiros ; Amando, Bruno Rocha ; Rocha, Marcos Fábio Gadelha ; Soares, Ana Carla de Castro Freitas ; Castelo-Branco, Débora de Souza Collares Maia ; Gomes, Francisco Ivanilsom Firmiano ; Guedes, Gláucia Morgana de Melo ; Pereira, Vinicius Carvalho ; Freitas, Alyne Soares ; Melo Guedes, Gláucia Morgana de

Otitis externa is an inflammatory disease of the external ear canal of complex and multifactorial etiology associated with recurrent bacterial infection. This study aimed to assess the antimicrobial and antibiofilm activity of promethazine against bacterial isolates from dogs with otitis externa, as well as the effect of this compound on the dynamics of biofilm formation over 120 h. Planktonic bacterial susceptibility to promethazine was evaluated to determine the minimum inhibitory concentrations (MIC). The minimum biofilm eradication concentration (MBEC) was also determined by broth microdilution. To evaluate the effect on biofilm growth, promethazine was tested at three concentrations MIC, MIC/2 and MIC/8, with daily readings at 48, 72, 96 and 120 h. The MICs of promethazine ranged from 48.83 to 781.25 μg mL^-1. Promethazine significantly (P < 0.05) reduced mature biofilm biomass, with MBECs ranging from 48.8 to 6250 μg mL^-1 and reduced (P < 0.01) biofilm formation for up to the 120-h, at concentrations corresponding to the MIC obtained against each isolate. Promethazine was effective against microorganisms associated with canine otitis externa. The data suggest that promethazine presents antimicrobial and antibiofilm activity and is a potential alternative to treat and prevent recurrent bacterial otitis in dogs. These results emphasize the importance of drug repurposing in veterinary otology as an alternative to reduce antimicrobial resistance.

2024-01-01·Clinical & Translational Immunology

Phenotypic spectrum in a family with a novel RAC2 p.I21S dominant‐activating mutation

作者: Hsiao, Kuang-Chih ; Chua, Ignatius ; Chan, Lydia ; Ameratunga, Rohan ; Keating, Paula ; Winterbourn, Christine ; Woon, See-Tarn ; Heller, Raoul ; Ashby, Louisa

AbstractObjectivesDominant‐activating (DA) lesions in RAC2 have been reported in 18 individuals to date. Some have required haematopoietic stem cell transplantation (HSCT) for their (severe) combined immunodeficiency syndrome phenotype. We aimed to investigate clinical and cellular features of a kindred harbouring a novel variant in RAC2 p.Ile21Ser (I21S) to better understand DA lesions' phenotypic spectrum.MethodsClinical and immunological information was collated for seven living individuals from the same kindred with RAC2 p.I21S. We evaluated neutrophil morphology, RAC2 protein expression and superoxide production using freshly isolated neutrophils stimulated with phorbol‐12‐myristate‐13‐acetate (PMA) and N‐formyl‐MetLeuPhe (fMLP).ResultsPatient 1 (P1, aged 11, male) has a history of bacterial suppurative otitis media, viral and bacterial cutaneous infections. P1's siblings (P2, P3), mother (P4), maternal aunt (P5) and uncle (P6) have similar infection histories. P1's maternal cousin (P7) presented with Burkitt's lymphoma at age 9. All affected individuals are alive and none has required HSCT to date. They have chronic lymphopenia affecting the CD4+T and B‐cell compartments. P1–3 have isolated reduction in IgM levels whereas the adults universally have normal immunoglobulins. Specific antibody responses are preserved. Affected individuals have neutrophil vacuolation, and their neutrophils have enhanced superoxide production compared to healthy controls.ConclusionRAC2 p.I21S is an activating variant causing notable morphological and functional abnormalities similar to other reported DA mutations. This novel variant expands the broad clinical phenotypic spectrum of RAC2 DA lesions, emphasising the need to tailor clinical management according to patients' disease phenotype and severity.

2023-12-01·International Journal of Pediatric Otorhinolaryngology

Otitis media at 6-monthly assessments of Australian First Nations children between ages 12–36 months: Findings from two randomised controlled trials of combined pneumococcal conjugate vaccines

Article

作者: Torzillo, P J ; Beissbarth, J ; Wilson, N ; Binks, M J ; Leach, A J ; Mulholland, E K ; Morris, P S ; Snelling, T ; McIntyre, P ; Santosham, M ; Skull, S A ; Krause, V ; Chatfield, M ; Carapetis, J ; Oguoma, V M ; Andrews, R ; Arrowsmith, B ; Chang, A B ; Lehmann, D ; Licciardi, P V ; Smith-Vaughan, H

OBJECTIVESIn remote communities of northern Australia, First Nations children with hearing loss are disproportionately at risk of poor school readiness and performance compared to their peers with no hearing loss. The aim of this trial is to prevent early childhood persisting otitis media (OM), associated hearing loss and developmental delay. To achieve this, we designed a mixed pneumococcal conjugate vaccine (PCV) schedule that could maximise immunogenicity and thereby prevent bacterial otitis media (OM) and a trajectory of educational and social disadvantage.METHODSIn two sequential parallel, open-label, randomised controlled trials, eligible infants were first allocated 1:1:1 to standard or mixed PCV primary schedules at age 28-38 days, then at age 12 months to a booster dose (1:1) of 13-valent PCV, PCV13 (Prevenar13®, +P), or 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugated vaccine, PHiD-CV10 (Synflorix®, +S). Here we report findings of standardised ear assessments conducted six-monthly from age 12-36 months, by booster dose.RESULTSFrom March 2013 to September 2018, 261 children were allocated to booster + P (n = 131) or + S (n = 130). There were no significant differences in prevalence of any OM diagnosis by booster dose or when stratified by primary schedule. We found high, almost identical prevalence of OM in both boost groups at each age (for example 88% of 129 and 91% of 128 children seen, respectively, at primary endpoint age 18 months, difference -3% [95% Confidence Interval -11, 5]). At each age prevalence of bilateral OM was 52%-78%, and tympanic membrane perforation was 10%-18%.CONCLUSIONDespite optimal pneumococcal immunisation, the high prevalence of OM persists throughout early childhood. Novel approaches to OM prevention are needed, along with improved early identification strategies and evaluation of expanded valency PCVs.