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1.
AAPS PharmSciTech ; 25(4): 77, 2024 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-38589761

RESUMO

Keratin has the potential to function as the gel matrix in an ophthalmic formulation for the encapsulation of the macrolide antibiotic azithromycin. The quality of this formulation was thoroughly evaluated through various analyses, such as in vitro release assessment, rheological examination, intraocular retention studies in rabbits, assessment of bacteriostatic efficacy, and safety evaluations. It is worth mentioning that the gel demonstrated shear thinning properties and exhibited characteristics of an elastic solid, thereby confirming its structural stability. The gel demonstrated a notable affinity for mucosal surfaces in comparison to traditional azithromycin aqueous solutions. In vitro release testing revealed that drug release transpired via diffusion mechanisms, following a first-order kinetic release pattern. Additionally, the formulated gel exhibited remarkable antibacterial efficacy against Staphylococcus aureus and Pseudomonas aeruginosa in bacteriostatic evaluations. Lastly, safety assessments confirmed that the gel eye drops induced minimal irritation and displayed no apparent cytotoxicity, indicating their good safety and biocompatibility for ocular application. Thus, these findings indicated that the prepared azithromycin gel eye drops complied with the requisite standards for ophthalmic preparations.


Assuntos
Conjuntivite Bacteriana , Sistemas de Liberação de Medicamentos , Animais , Coelhos , Azitromicina/farmacologia , Queratinas/uso terapêutico , Conjuntivite Bacteriana/tratamento farmacológico , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Géis/química , Soluções Oftálmicas/química
2.
Klin Monbl Augenheilkd ; 241(2): 231-246, 2024 Feb.
Artigo em Alemão | MEDLINE | ID: mdl-37977204

RESUMO

Bacterial conjunctivitis is a leading cause of infectious conjunctivitis in children and second most common cause in adults. Although often self-limiting, it can lead to complications like corneal scarring and systemic infections in high-risk groups including newborns and immunocompromised patients. Thus, prompt diagnosis and treatment are essential for these vulnerable populations. Common bacterial causes are Staphylococcus aureus and Streptococcus pneumoniae in adults and Haemophilus influenzae and Moraxella catarrhalis in children. Clinical features alone do not reliably identify the causative pathogen. Microbiological testing is necessary for persistent or severe cases. Topical antibiotics like azithromycin or fluorochinolones are usually prescribed. However, gonococcal and chlamydial conjunctivitis warrant systemic antibiotics due to their potential for severe complications. Increasing antibiotic resistance might even necessitate tailored therapy based on antibiotic susceptibility profiles. Screening and treating pregnant women is an effective prevention strategy by reducing perinatal transmission (especially of gonococcal and chlamydial infections). In summary, while often self-limiting, potential complications and rising antibiotic resistance underscore the importance of timely diagnosis and treatment of bacterial conjunctivitis. Preventive measures including maternal screening are crucial public health initiatives to curb the risks associated with this common eye infection.


Assuntos
Conjuntivite Bacteriana , Conjuntivite , Recém-Nascido , Criança , Adulto , Humanos , Feminino , Gravidez , Transmissão Vertical de Doenças Infecciosas , Antibacterianos/uso terapêutico , Conjuntivite Bacteriana/diagnóstico , Conjuntivite Bacteriana/tratamento farmacológico , Azitromicina/uso terapêutico
3.
Am J Ophthalmol ; 257: 143-153, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37482371

RESUMO

PURPOSE: To summarize key findings from a Cochrane review of the benefits and safety of antibiotic therapy compared with placebo (or vehicle) for acute bacterial conjunctivitis. DESIGN: Systematic review and meta-analysis. METHODS: We included placebo-controlled randomized controlled trials (RCTs) that compared topical antibiotics with placebo. We followed Cochrane methods for trial selection, data extraction, risk of bias assessment, and evidence synthesis. RESULTS: Twenty-one RCTs involving 8805 participants with acute bacterial conjunctivitis were included. Fifteen (71%) RCTs examined fluoroquinolone (FQ) drops, 3 tested macrolides, alone or in combination with steroids, and another 3 compared other non-FQ antibiotics. Intention-to-treat estimates suggested that compared with placebo, antibiotics may increase clinical recovery by 26% (risk ratio [RR]: 1.26; 95% confidence interval [CI]: 1.09-1.46) at the end of therapy (5 RCTs, 1474 participants). Modified intention-to-treat estimates, in which only participants with laboratory-confirmed bacterial conjunctivitis were analyzed, indicated that antibiotics were associated with 53% higher likelihood of microbiological cure as compared with placebo (RR: 1.53; 95% CI: 1.34-1.74; 10 RCTs, 2827 participants). Non-FQs (RR: 4.05; 95% CI: 1.36-12.00), but not FQs (RR: 0.70; 95% CI: 0.54-0.90), were likely to increase treatment-associated ocular complications such as eye pain, discomfort, and allergic reactions; the certainty of level of evidence was very low. CONCLUSIONS: Moderate level certainty of evidence suggested that antibiotics may increase the likelihood of clinical recovery and microbiological clearance compared with placebo. Very low-level certainty of evidence suggested that antibiotics may be associated with potential harm in patients with acute bacterial conjunctivitis, but the potential risk of bias from study design, inconsistency in outcome measurement, and reporting limit the evidence to very low certainty.


Assuntos
Antibacterianos , Conjuntivite Bacteriana , Humanos , Antibacterianos/uso terapêutico , Conjuntivite Bacteriana/tratamento farmacológico
5.
ACS Appl Mater Interfaces ; 15(19): 22892-22902, 2023 May 17.
Artigo em Inglês | MEDLINE | ID: mdl-37154428

RESUMO

Ocular formulations should provide an effective antibiotic concentration at the site of infection to treat bacterial eye infections. However, tears and frequent blinking accelerate the drug clearance rate and limit drug residence time on the ocular surface. This study describes a biological adhesion reticulate structure (BNP/CA-PEG) consisting of antibiotic-loaded bioadhesion nanoparticles (BNP/CA), with an average 500-600 nm diameter, and eight-arm NH2-PEG-NH2 for local and extended ocular drug delivery. This retention-prolonging effect is a function of the Schiff base reaction between groups on the surface of BNP and amidogen on PEG. BNP/CA-PEG showed significantly higher adhesion properties and better treatment efficacy in an ocular rat model with conjunctivitis in comparison to non-adhesive nanoparticles, BNP, or free antibiotics. Both in vivo safety experiment and in vitro cytotoxicity test verified the biocompatibility and biosafety of the biological adhesion reticulate structure, indicating a promising translational prospect for further clinical use.


Assuntos
Conjuntivite Bacteriana , Nanopartículas , Ratos , Animais , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Antibacterianos/química , Sistemas de Liberação de Medicamentos , Conjuntivite Bacteriana/tratamento farmacológico , Nanopartículas/química , Resultado do Tratamento
7.
Chemotherapy ; 68(4): 228-232, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37231886

RESUMO

Neisseria meningitidis represents an uncommon pathogen of acute bacterial conjunctivitis. In this brief report, we describe a case of meningococcal conjunctivitis in an immunocompetent adult male, with a review of the literature. The patient went to the outpatient ophthalmology clinic complaining of severe ocular discomfort, burning, and redness for more than 2 weeks and, at slit lamp examination, he was diagnosed with a mild conjunctivitis. Microbiology cultures of ocular swabs revealed the growth of colonies, as pure culture, identified as N. meningitidis of serogroup B. A diagnosis of primary meningococcal conjunctivitis was made and treatment of patient with intramuscular injections of ceftriaxone in addition to topical moxifloxacin eye drops for 2 weeks led to clinical improvement and, finally, to a complete recovery, in accordance with microbiological findings. Ophthalmologists must be aware of the possibility of primary meningococcal conjunctivitis cases, even uncommon, and the need to treat with systemic antibiotics and their close contacts with adequate antibiotic chemoprophylaxis.


Assuntos
Conjuntivite Bacteriana , Conjuntivite , Infecções Meningocócicas , Neisseria meningitidis , Adulto , Masculino , Humanos , Pessoa de Meia-Idade , Infecções Meningocócicas/diagnóstico , Infecções Meningocócicas/tratamento farmacológico , Infecções Meningocócicas/microbiologia , Conjuntivite Bacteriana/diagnóstico , Conjuntivite Bacteriana/tratamento farmacológico , Conjuntivite Bacteriana/microbiologia , Antibacterianos/uso terapêutico , Conjuntivite/diagnóstico , Conjuntivite/tratamento farmacológico , Conjuntivite/microbiologia
8.
Cochrane Database Syst Rev ; 3: CD001211, 2023 03 13.
Artigo em Inglês | MEDLINE | ID: mdl-36912752

RESUMO

BACKGROUND: Acute bacterial conjunctivitis is an infection of the conjunctiva and is one of the most common ocular disorders in primary care. Antibiotics are generally prescribed on the basis that they may speed recovery, reduce persistence, and prevent keratitis. However, many cases of acute bacterial conjunctivitis are self-limited, resolving without antibiotic therapy. This Cochrane Review was first published in The Cochrane Library in 1999, then updated in 2006, 2012, and 2022. OBJECTIVES: To assess the benefits and side effects of antibiotic therapy in the management of acute bacterial conjunctivitis. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2022, Issue 5), MEDLINE (January 1950 to May 2022), Embase (January 1980 to May 2022), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www. CLINICALTRIALS: gov), and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases in May 2022.   SELECTION CRITERIA: We included randomized controlled trials (RCTs) in which any form of antibiotic treatment, with or without steroid, had been compared with placebo/vehicle in the management of acute bacterial conjunctivitis. This included topical and systemic antibiotic treatments. DATA COLLECTION AND ANALYSIS: Two authors independently reviewed the titles and abstracts of identified studies. We assessed the full text of all potentially relevant studies and determined the included RCTs, which were further assessed for risk of bias using Cochrane methodology. We performed data extraction in a standardized manner and conducted random-effects meta-analyses using RevMan Web. MAIN RESULTS: We included 21 eligible RCTs, 10 of which were newly identified in this update. A total of 8805 participants were randomized. All treatments were topical in the form of drops or ointment. The trials were heterogeneous in terms of their eligibility criteria, the nature of the intervention (antibiotic drug class, which included fluoroquinolones [FQs] and non-FQs; dosage frequency; duration of treatment), the outcomes assessed and the time points of assessment. We judged one trial to be of high risk of bias, four as low risk of bias, and the others as raising some concerns. Based on intention-to-treat (ITT) population, antibiotics likely improved clinical cure (resolution of clinical symptoms or signs) by 26% (RR 1.26, 95% CI 1.09 to 1.46; 5 trials, 1474 participants; moderate certainty) as compared with placebo. Subgroup analysis showed no differences by antibiotic class (P = 0.67) or treatment duration (P = 0.60). In the placebo group, 55.5% (408/735) of participants had spontaneous clinical resolution by days 4 to 9 versus 68.2% (504/739) of participants treated with an antibiotic. Based on modified ITT population, in which participants were analyzed after randomization on the basis of positive microbiological culture, antibiotics likely increased microbiological cure (RR 1.53, 95% CI 1.34 to 1.74; 10 trials, 2827 participants) compared with placebo at the end of therapy; there were no subgroup differences by drug class (P = 0.60). No study evaluated the cost-effectiveness of antibiotic treatment. Patients receiving antibiotics had a lower risk of treatment incompletion than those in the placebo group (RR 0.64, 95% CI 0.52 to 0.78; 13 trials, 5573 participants; moderate certainty) and were 27% less likely to have persistent clinical infection (RR 0.73, 95% CI 0.65 to 0.81; 19 trials, 5280 participants; moderate certainty). There was no evidence of serious systemic side effects reported in either the antibiotic or placebo group (very low certainty). When compared with placebo, FQs (RR 0.70, 95% CI 0.54 to 0.90) but not non-FQs (RR 4.05, 95% CI 1.36 to 12.00) may result in fewer participants with ocular side effects. However, the estimated effects were of very low certainty. AUTHORS' CONCLUSIONS: The findings of this update suggest that the use of topical antibiotics is associated with a modestly improved chance of resolution in comparison to the use of placebo. Since no evidence of serious side effects was reported, use of antibiotics may therefore be considered to achieve better clinical and microbiologic efficacy than placebo. Increasing the proportion of participants with clinical cure or increasing the speed of recovery or both are important for individual return to work or school, allowing people to regain quality of life. Future studies may examine antiseptic treatments with topical antibiotics for reasons of cost and growing antibiotic resistance.


Assuntos
Antibacterianos , Conjuntivite Bacteriana , Humanos , Antibacterianos/efeitos adversos , Conjuntivite Bacteriana/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto
10.
Eye Contact Lens ; 49(1): 35-41, 2023 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-36544283

RESUMO

PURPOSE: To determine the safety and efficacy of black tea extract in the treatment of bacterial conjunctivitis in a rabbit model and compare it with that of gatifloxacin drops. METHODS: Black tea extract was tested in vitro on bacterial cultures of methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa. Forty-two rabbit eyes were cultured with either MRSA (n=21) or P. aeruginosa (n=21) and further divided into a control group (n=5), a tea group (n=8) treated with black tea extract, and a gatifloxacin group (n=8) treated with 0.3% gatifloxacin eye drops. Conjunctival swabs were collected on the third and fifth days. RESULTS: The tea extract successfully inhibited the growth of both organisms at a concentration of 400 mg/mL. Rabbits in the treatment groups showed a reduction in the clinical index on day 2 (P<0.01), unlike the control group (P=0.1), for both organisms. Resolution of conjunctivitis was achieved on days 4 and 5 in the tea and gatifloxacin groups, respectively. On days 3 and 5, while the control group still showed considerable bacterial growth, the tea and gatifloxacin groups showed its inhibition. CONCLUSION: Tea extract has antimicrobial effects similar to those of gatifloxacin in a rabbit model of conjunctivitis.


Assuntos
Conjuntivite Bacteriana , Conjuntivite , Staphylococcus aureus Resistente à Meticilina , Animais , Coelhos , Gatifloxacina/farmacologia , Gatifloxacina/uso terapêutico , Fluoroquinolonas/uso terapêutico , Conjuntivite Bacteriana/tratamento farmacológico , Conjuntivite/tratamento farmacológico , Chá , Antibacterianos/uso terapêutico , Antibacterianos/farmacologia
12.
BMJ Case Rep ; 15(1)2022 Jan 13.
Artigo em Inglês | MEDLINE | ID: mdl-35027379

RESUMO

Giant fornix syndrome (GFS) results in chronic, relapsing conjunctivitis in elderly patients with enophthalmos and enlarged fornices, in which infectious material collects and perpetuates inflammation. A 98-year-old woman presented with persistent, bilateral, purulent conjunctivitis; corneal epithelial defects and progressive blepharospasm that did not respond to artificial tears, topical antibiotics and steroids and amniotic membrane grafts. Additional findings of deep-set orbits with enlarged upper fornices were diagnostic of GFS. Over the next 2 months, she responded to a combination of topical and systemic antibiotics, autologous serum eye drops, povidone-iodine forniceal rinses, and hypochlorous acid treatment of the eyelashes. GFS is an important diagnostic consideration in elderly patients with chronic conjunctivitis and deep-set orbits.


Assuntos
Doenças da Túnica Conjuntiva , Conjuntivite Bacteriana , Conjuntivite , Infecções Estafilocócicas , Idoso , Idoso de 80 Anos ou mais , Conjuntivite/diagnóstico , Conjuntivite/tratamento farmacológico , Conjuntivite Bacteriana/diagnóstico , Conjuntivite Bacteriana/tratamento farmacológico , Feminino , Humanos , Lubrificantes Oftálmicos , Povidona-Iodo
13.
Eye (Lond) ; 36(5): 1066-1073, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-34035495

RESUMO

OBJECTIVE: To investigate the association between exposure to topical ophthalmic antibiotics during pregnancy and adverse neonatal outcomes. METHODS: In this retrospective cohort study, we identified pregnant women with hordeola, chalazia, blepharitis, or bacterial conjunctivitis from 2005 to 2018 using the Japanese Medical Data Centre Claims Database. From the eligible women, we extracted women who were dispensed no topical antibiotics during the first trimester (non-antibiotic group), women who were dispensed topical fluoroquinolones alone at least once (fluoroquinolone alone group), and women who were dispensed any single type of antibiotic (single-antibiotic group). We compared the frequency of congenital anomalies (CA), preterm birth (PB), low birth weight (LBW), and the composite outcome of these three between the fluoroquinolone and non-antibiotic groups and between the single-antibiotic and non-antibiotic groups, using propensity score adjustment. RESULTS: A total of 891 eligible women were identified. In the fluoroquinolone (n = 409) and non-antibiotic (n = 309) groups, CA occurred in 6.8% and 6.8%, PB in 2.4% and 3.2%, LBW in 2.9% and 3.2%, and the composite outcome in 10.5% and 11.3%, respectively. Analysis using propensity score adjustment showed no significant difference between the groups in the frequency of CA (adjusted odds ratio, 1.15; 95% confidence interval, 0.61-2.18), PB (0.80; 0.30-2.17), LBW (1.08; 0.45-2.63), or the composite outcome (1.12; 0.67-1.87). Comparison of the single-antibiotic and non-antibiotic groups showed similar results. CONCLUSIONS: Topical ophthalmic antibiotics for hordeola, chalazia, blepharitis, or bacterial conjunctivitis during the first trimester were not associated with increased adverse neonatal outcomes.


Assuntos
Blefarite , Calázio , Conjuntivite Bacteriana , Nascimento Prematuro , Antibacterianos/efeitos adversos , Blefarite/induzido quimicamente , Blefarite/tratamento farmacológico , Calázio/induzido quimicamente , Calázio/tratamento farmacológico , Conjuntivite Bacteriana/induzido quimicamente , Conjuntivite Bacteriana/tratamento farmacológico , Conjuntivite Bacteriana/microbiologia , Feminino , Fluoroquinolonas/efeitos adversos , Humanos , Recém-Nascido , Gravidez , Gestantes , Nascimento Prematuro/induzido quimicamente , Nascimento Prematuro/tratamento farmacológico , Pontuação de Propensão , Estudos Retrospectivos
14.
J Med Microbiol ; 70(9)2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34494952

RESUMO

Introduction. Gonorrhoea is a sexually transmitted disease whose incidence has increased in recent years and adult gonococcal conjunctivitis (AGC) is a relatively uncommon complication.Hypothesis/Gap Statement. AGC is associated with increased incidence of genital gonorrhoea and must be treated correctly to avoid serious corneal complications.Aims. To report the prevalence, clinical features, and complications of AGC in a tertiary ophthalmology centre in Barcelona, Spain. Present epidemiological data, clinical features, ocular complications, and antibiotic susceptibility. Design: Single-centre, descriptive, retrospective case series.Methodology. Systematic case-defined search in medical records and further retrospective chart review study of microbiologically confirmed AGC attending outpatient clinic and/or emergency room from 2012 to 2020. We analysed the clinical presentation, treatments, antibiotic susceptibility, complications and ocular sequelae.Results. Thirteen patients were diagnosed of AGC. Eleven patients had unilateral presentation. Two patients had bilateral presentation. In ten cases there was abundant mucopurulent discharge, three cases presented periocular pain and periocular inflammation requiring a CT scan to rule out post-septal cellulitis. The diagnosis was confirmed by culture. In total, 100 % of strains were susceptible to ceftriaxone, 58 % were ciprofloxacin resistant and no beta-lactamase production was detected. Three patients required hospital admission. One patient developed a complication presenting with ptosis caused by superior symblepharon.Conclusion. AGC is a rare disease which is difficult to diagnose as it requires a high index of suspicion to prevent corneal perforation but in an important number of cases it may mimic orbital cellulitis. It is crucial that treatment starts as soon as possible to avoid serious corneal damage. Patients should promptly receive complete and correct treatment when admitted to the emergency room since an elevated number of patients do not attend their medical follow-up visit. Azithromycin or aminoglycoside eye drops are probably the best option to complete the treatment, due to high quinolone resistance.


Assuntos
Conjuntivite Bacteriana , Gonorreia , Neisseria gonorrhoeae/isolamento & purificação , Soluções Oftálmicas/uso terapêutico , Adolescente , Adulto , Aminoglicosídeos/uso terapêutico , Antibacterianos/uso terapêutico , Azitromicina/uso terapêutico , Conjuntivite Bacteriana/tratamento farmacológico , Conjuntivite Bacteriana/epidemiologia , Gonorreia/tratamento farmacológico , Gonorreia/epidemiologia , Humanos , Pessoa de Meia-Idade , Prevalência , Estudos Retrospectivos , Espanha/epidemiologia , Adulto Jovem
15.
J Pharm Sci ; 110(8): 3027-3036, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33940026

RESUMO

In the present study, we aimed to formulate, optimize, and characterize azithromycin chitosan coated niosomes (AZM-CTS-NSM) as a novel colloidal system that increases precorneal residence period, eye permeation, and bioavailability. AZM-NSM was formulated via a modified thin-film hydration strategy and then coated with CTS. We assessed the influence of the cholesterol: surfactant molar ratio, CTS concentration, and surfactant type on particle diameter, entrapment, zeta potential, and NSM adhesion force to the corneal mucosal membrane and employed a central composite design (CCD). The resulting optimized AZM-CTS-NSM has a mean diameter of 376 nm, entrapment of 74.2%, surface charge of 32.1 mV, and mucoadhesion force of 3114 dyne/cm2. The optimized AZM-CTS-NSM demonstrated a prolonged in vitro release behavior. When compared with commercial eye drops, the optimized AZM-CTS-NSM produced a 2.61-fold increase in the apparent permeability coefficient, significantly improving corneal permeability. Additionally, ocular irritation was assessed, with no major irritant effects found to be induced by the formulated NSM. Compared with AZM commercial drops, the optimized AZM-CTS-NSM revealed ˃ 3-fold increase in AZM concentration in the rabbit eyes. Collectively, these findings indicate that CTS-NSM is a potentially valuable ocular nanocarrier that could augment the efficacy of AZM.


Assuntos
Quitosana , Conjuntivite Bacteriana , Animais , Azitromicina , Conjuntivite Bacteriana/tratamento farmacológico , Córnea , Sistemas de Liberação de Medicamentos , Lipossomos , Tamanho da Partícula , Coelhos
16.
Nepal J Ophthalmol ; 13(25): 137-140, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33981108

RESUMO

INTRODUCTION: This is a case of case of acute gonococcal conjunctivitis in a 2.5 years old female child. CASE: A 2.5 years old female child presented with redness, purulent and profuse discharge from left eye with associated upper eyelid swelling. The culture of conjunctival swab revealed Neisseria gonorrhoeae. The child was treated with intravenous antibiotics and fortified medications. CONCLUSION: Unlike young adults and newborn gonococcal conjunctivitis (GCC), children can have a nonsexual mode of transmission and could be seen in an unusual age group. For the management of the diseases, proper history including sexual abuse history and thorough physical examination is mandatory, which is sometimes difficult in a developing country. Gonococcal conjunctivitis in the toddler group should be kept in consideration.


Assuntos
Conjuntivite Bacteriana , Conjuntivite , Gonorreia , Antibacterianos/uso terapêutico , Pré-Escolar , Conjuntivite/tratamento farmacológico , Conjuntivite Bacteriana/diagnóstico , Conjuntivite Bacteriana/tratamento farmacológico , Feminino , Gonorreia/complicações , Gonorreia/diagnóstico , Gonorreia/tratamento farmacológico , Humanos , Recém-Nascido , Neisseria gonorrhoeae , Adulto Jovem
17.
JAMA Ophthalmol ; 139(2): 214-217, 2021 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-33331874

RESUMO

Importance: Off-label treatment was common for ophthalmia neonatorum because only erythromycin ointment had been approved by the US Food and Drug Administration (FDA) for this indication. Ophthalmia neonatorum was previously considered a different indication from bacterial conjunctivitis in older children and adults because of uncertain similarities in the cause of disease and the treatment course between the 2 populations. Prospective therapeutic clinical studies were required to demonstrate the effectiveness of treatment for ophthalmia neonatorum. Objective: To review the therapeutic clinical trials for patients with bacterial conjunctivitis to evaluate the similarity in the cause of disease and the treatment response between neonates and older children and adults. Design, Setting, and Participants: In this comparative effectiveness research review of pooled data from the most recent 30 bacterial conjunctivitis trials (N = 2018) submitted to the FDA to support the approval of topical ophthalmic solutions for older children and adults, 95% CIs were constructed from clinical cure rates. Cure rates in 3 neonatal randomized clinical trials (N = 392) of patients treated with ophthalmic anti-infective solutions of ciprofloxacin, gatifloxacin, and moxifloxacin were constructed and compared. The baseline ocular swab cultures were analyzed. Main Outcomes and Measures: Cure rates of neonatal trials were compared with the 95% CIs among older children and adults. The bacterial organisms isolated from these 2 populations were compared. Results: The 3 neonatal trials enrolled a total of 392 patients, and the 30 trials of older children and adults enrolled a total of 2018 patients. Neonatal clinical cure rates for moxifloxacin (day 4, 48%), ciprofloxacin (day 4, 49%; day 5, 61%), and gatifloxacin (day 7, 79%) were within the 95% CI for products approved to treat older children and adults with bacterial conjunctivitis. Bacterial organisms were consistent between these 2 populations. Conclusions and Relevance: Comparison of the pooled analysis of these historical trial data suggests similarity in the cause of disease and the treatment response between neonates and older children and adults with bacterial conjunctivitis. Therefore, it was appropriate to extrapolate the effectiveness from older children and adults to neonates to support the approval of therapies for ophthalmia neonatorum. Based on this analysis, ophthalmic solutions of ciprofloxacin, gatifloxacin, and moxifloxacin are now approved for all age groups. This analysis presents an approach of using pooled data from previously underpowered individual trials to establish the similarities in the cause of disease and in treatment response between children and adults, which are the fundamental elements used to evaluate whether extrapolation of effectiveness can be used to support drug approval.


Assuntos
Antibacterianos/administração & dosagem , Conjuntivite Bacteriana/tratamento farmacológico , Aprovação de Drogas , Medicina Baseada em Evidências , Oftalmia Neonatal/tratamento farmacológico , United States Food and Drug Administration , Administração Oftálmica , Fatores Etários , Antibacterianos/efeitos adversos , Pesquisa Comparativa da Efetividade , Conjuntivite Bacteriana/diagnóstico , Conjuntivite Bacteriana/microbiologia , Humanos , Recém-Nascido , Oftalmia Neonatal/diagnóstico , Oftalmia Neonatal/microbiologia , Soluções Oftálmicas , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão , Resultado do Tratamento , Estados Unidos
19.
PLoS One ; 15(8): e0237603, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32841261

RESUMO

BACKGROUND/PURPOSE: To date, studies examining polymicrobial infections in ocular disease have mostly been limited to keratitis or endophthalmitis. We characterized polybacterial infections compared to monobacterial infections in prior clinical studies evaluating besifloxacin ophthalmic suspension 0.6% for the treatment of bacterial conjunctivitis and report on associated microbiological outcomes. METHODS: In this post-hoc analysis, microbiological data for subjects with conjunctivitis due to one or more than one bacterial species in three previous studies (two vehicle-, one active-controlled) of besifloxacin were extracted. Bacterial species identified at baseline were deemed causative if their colony count equaled or exceeded species-specific prespecified threshold criteria. In subjects with polybacterial infections, the fold-increase over threshold was used to rank order the contribution of individual species. Baseline pathogens and their minimum inhibitory concentrations (MICs) for common ophthalmic antibiotics were compared by infection type, as were microbial eradication rates following treatment with besifloxacin. RESULTS: Of 1041 subjects with culture-confirmed conjunctivitis, 17% had polybacterial and 83% had monobacterial conjunctivitis at baseline. In polybacterial compared to monobacterial infections, Haemophilus influenzae and Streptococcus pneumoniae were identified less frequently as the dominant infecting species (P = 0.042 and P<0.001, respectively), whereas Streptococcus mitis/S. mitis group was identified more frequently as dominant (P<0.001). Viral coinfection was also identified more frequently in polybacterial infections (P<0.001). Staphylococcus aureus was the most common coinfecting species in polybacterial infections and the second most common dominant species in such infections. With few exceptions, MICs for individual species were comparable regardless of infection type. Clinical microbial eradication rates with besifloxacin were high regardless of infection type (P≤0.016 vs vehicle at follow-up visits). CONCLUSIONS: Approximately one in five subjects with bacterial conjunctivitis are infected with more than one bacterial species underscoring the need for a broad-spectrum antibiotic for such infections. Besifloxacin treatment resulted in robust eradication rates of these infections comparable to monobacterial infections. TRIAL REGISTRATION: NCT000622908, NCT00347932, NCT00348348.


Assuntos
Antibacterianos/uso terapêutico , Azepinas/uso terapêutico , Bactérias/classificação , Bactérias/efeitos dos fármacos , Conjuntivite Bacteriana/tratamento farmacológico , Fluoroquinolonas/uso terapêutico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Conjuntivite Bacteriana/microbiologia , Conjuntivite Bacteriana/patologia , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Lactente , Recém-Nascido , Masculino , Testes de Sensibilidade Microbiana , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos , Adulto Jovem
20.
Am J Case Rep ; 21: e923135, 2020 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-32536685

RESUMO

BACKGROUND Neisseria-associated conjunctivitis is a rare cause of bacterial conjunctivitis in adults, with Neisseria gonorrhoeae as the primarily identified infectious strain. Here, we present a rare case of bacterial conjunctivitis due to Neisseria sicca in a 34-year-old immunocompetent man with no prior medical or ocular history. CASE REPORT A 34-year-old man with no significant past medical or ocular history presented with a 3-day history of left periorbital edema, ocular pain, and copious purulent discharge. Bacterial conjunctivitis was suspected due to the rapidity of onset and purulence. Peripheral corneal thinning was identified. Preliminary culture results showed gram-negative diplococci, and the patient was treated for gonococcal infection. Final cultures identified Neisseria sicca, a rarely pathogenic strain of Neisseria species. CONCLUSIONS This is the second reported case of Neisseria sicca-associated conjunctivitis, and the first reported case to have corneal involvement. Neisseria sicca, while typically non-pathogenic, may manifest as conjunctivitis in immunocompetent hosts with a low-risk sexual history.


Assuntos
Ceftriaxona/uso terapêutico , Conjuntivite Bacteriana/tratamento farmacológico , Conjuntivite Bacteriana/microbiologia , Moxifloxacina/uso terapêutico , Infecções por Neisseriaceae/tratamento farmacológico , Infecções por Neisseriaceae/microbiologia , Antibacterianos/uso terapêutico , Humanos , Masculino , Neisseria sicca
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