RESUMO
Gonorrhea remains a major public health challenge, and current recommendations for gonorrhea treatment are threatened by evolving antimicrobial resistance and a diminished pipeline for new antibiotics. Evaluations of potential new treatments for gonorrhea currently make limited use of new understanding of the pharmacokinetic and pharmacodynamic contributors to effective therapy, the prevention of antimicrobial resistance, and newer designs for clinical trials. They are hampered by the requirement to utilize combination ceftriaxone/azithromycin therapy as the comparator regimen in noninferiority trials designed to seek an indication for gonorrhea therapy. Evolving gonococcal epidemiology and clinical trial design constraints hinder the enrollment of those populations at the greatest risk for gonorrhea (adolescents, women, and persons infected with antibiotic-resistant Neisseria gonorrhoeae). This article summarizes a recent meeting on the evaluation process for antimicrobials for urogenital gonorrhea treatment and encourages the consideration of new designs for the evaluation of gonorrhea therapy.
Assuntos
Anti-Infecciosos , Gonorreia , Adolescente , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Anti-Infecciosos/farmacologia , Azitromicina/farmacologia , Azitromicina/uso terapêutico , Ceftriaxona/farmacologia , Ceftriaxona/uso terapêutico , Ensaios Clínicos como Assunto , Farmacorresistência Bacteriana , Feminino , Gonorreia/tratamento farmacológico , Humanos , Testes de Sensibilidade Microbiana , Neisseria gonorrhoeaeRESUMO
BACKGROUND: Syphilis prevalence in sub-Saharan Africa appears to be stable or declining but is still the highest globally. Ongoing sentinel surveillance in high-risk populations is necessary to inform management and detect changes in syphilis trends. We assessed serological syphilis markers among persons with sexually transmitted infections in Zimbabwe. METHODS: We studied a predominantly urban, regionally diverse group of women and men presenting with genital ulcer disease (GUD), women with vaginal discharge and men with urethral discharge at clinics in Zimbabwe. Syphilis tests included rapid plasma reagin and the Treponema pallidum hemagglutination assay. RESULTS: Among 436 evaluable study participants, 36 (8.3%) tested positive for both rapid plasma reagin and Treponema pallidum hemagglutination assay: women with GUD: 19.2%, men with GUD: 12.6%, women with vaginal discharge: 5.7% and men with urethral discharge: 1.5% (P < 0.0001). CONCLUSIONS: Syphilis rates in Zimbabwe are high in sentinel populations, especially men and women with GUD.
Assuntos
Infecções Sexualmente Transmissíveis/microbiologia , Sífilis/sangue , Sífilis/diagnóstico , Adolescente , Adulto , Biomarcadores/sangue , Feminino , Genitália/patologia , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Vigilância de Evento Sentinela , Infecções Sexualmente Transmissíveis/epidemiologia , Sífilis/epidemiologia , Treponema pallidum , Úlcera/microbiologia , População Urbana/estatística & dados numéricos , Descarga Vaginal/microbiologia , Adulto Jovem , Zimbábue/epidemiologiaRESUMO
BACKGROUND: Dual human immunodeficiency virus (HIV)/syphilis rapid, point-of-care testing may enhance syphilis screening among high-risk populations, increase case finding, reduce time to treatment, and prevent complications. We assessed the laboratory-based performance of a rapid dual HIV/syphilis test using serum collected from patients enrolled in the Zimbabwe Sexually Transmitted Infections (STI) Etiology study. METHODS: Blood specimens were collected from patients presenting with STI syndromes in 6, predominantly urban STI clinics in different regions of Zimbabwe. All specimens were tested at a central research laboratory using the Standard Diagnostics Bioline HIV/Syphilis Duo test. The treponemal syphilis component of the dual rapid test was compared with the Treponema pallidum hemagglutination assay (TPHA) as a gold standard comparator, both alone or in combination with a nontreponemal test, the rapid plasma reagin test. The HIV component of the dual test was compared with a combination of HIV rapid tests conducted at the research laboratory following the Zimbabwe national HIV testing algorithm. RESULTS: Of 600 men and women enrolled in the study, 436 consented to serological syphilis and HIV testing and had specimens successfully tested by all assays. The treponemal component of the dual test had a sensitivity of 66.2% (95% confidence interval [CI], 55.2%-77.2%) and a specificity of 96.4% (95% CI, 94.5%-98.3%) when compared with TPHA; the sensitivity increased to 91.7% (95% CI, 82.6%-99.9%) when both TPHA and rapid plasma reagin were positive. The HIV component of the dual test had a sensitivity of 99.4% (95% CI, 98.4%-99.9%) and a specificity of 100% (95% CI, 99.9%-100%) when compared with the HIV testing algorithm. CONCLUSIONS: Laboratory performance of the SD Bioline HIV/Syphilis Duo test was high for the HIV component of the test. Sensitivity of the treponemal component was lower than reported from most laboratory-based evaluations in the literature. However, sensitivity of the test increased substantially among patients more likely to have active syphilis for which results of both standard treponemal and nontreponemal tests were positive.
Assuntos
Técnicas de Laboratório Clínico/normas , Infecções por HIV/diagnóstico , Testes Imediatos/normas , Testes Sorológicos/normas , Sorodiagnóstico da Sífilis/normas , Sífilis/diagnóstico , Adolescente , Adulto , Anticorpos Antibacterianos/sangue , Técnicas de Laboratório Clínico/métodos , Feminino , HIV , Infecções por HIV/sangue , Humanos , Masculino , Pessoa de Meia-Idade , Kit de Reagentes para Diagnóstico/normas , Sensibilidade e Especificidade , Sífilis/sangue , Sorodiagnóstico da Sífilis/métodos , Treponema pallidum , Adulto Jovem , ZimbábueRESUMO
INTRODUCTION: Sexually transmitted infections (STIs) are managed syndromically in most developing countries. In Zimbabwe, men presenting with urethral discharge are treated with a single intramuscular dose of kanamycin or ceftriaxone in combination with a week's course of oral doxycycline. This study was designed to assess the current etiology of urethral discharge and other STIs to inform current syndromic management regimens. METHODS: We conducted a study among 200 men with urethral discharge presenting at 6 regionally diverse STI clinics in Zimbabwe. Urethral specimens were tested by multiplex polymerase chain reaction testing for Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, and Trichomonas vaginalis. In addition, serologic testing for syphilis and HIV was performed. RESULTS: Among the 200 studied men, one or more pathogens were identified in 163 (81.5%) men, including N. gonorrhoeae in 147 (73.5%), C. trachomatis in 45 (22.5%), T. vaginalis in 8 (4.0%), and M. genitalium in 7 (3.5%). Among all men, 121 (60%) had a single infection, 40 (20%) had dual infections, and 2 (1%) had 3 infections. Among the 45 men with C. trachomatis, 36 (80%) were coinfected with N. gonorrhoeae. Overall, 156 (78%) men had either N. gonorrhoeae or C. trachomatis identified. Of 151 men who consented to HIV testing, 43 (28.5%) tested positive. There were no differences in HIV status by study site or by urethral pathogen detected. CONCLUSIONS: Among men presenting at Zimbabwe STI clinics with urethral discharge, N. gonorrhoeae and C. trachomatis are the most commonly associated pathogens. Current syndromic management guidelines seem to be adequate for the treatment for symptomatic men, but future guidelines must be informed by ongoing monitoring of gonococcal resistance.
Assuntos
Antibacterianos/administração & dosagem , Infecções Sexualmente Transmissíveis/microbiologia , Supuração/microbiologia , Uretrite/microbiologia , Adulto , Ceftriaxona/administração & dosagem , Doxiciclina/administração & dosagem , Inquéritos Epidemiológicos , Humanos , Canamicina/administração & dosagem , Masculino , Reação em Cadeia da Polimerase Multiplex , Técnicas de Amplificação de Ácido Nucleico , Comportamento Sexual , Infecções Sexualmente Transmissíveis/complicações , Infecções Sexualmente Transmissíveis/tratamento farmacológico , Uretrite/tratamento farmacológico , Uretrite/etiologia , Zimbábue/epidemiologiaRESUMO
BACKGROUND: In many countries, sexually transmitted infections (STIs) are treated syndromically. Thus, patients diagnosed as having genital ulcer disease (GUD) in Zimbabwe receive a combination of antimicrobials to treat syphilis, chancroid, lymphogranuloma venereum (LGV), and genital herpes. Periodic studies are necessary to assess the current etiology of GUD and assure the appropriateness of current treatment guidelines. MATERIALS AND METHODS: We selected 6 geographically diverse clinics in Zimbabwe serving high numbers of STI cases to enroll men and women with STI syndromes, including GUD. Sexually transmitted infection history and risk behavioral data were collected by questionnaire and uploaded to a Web-based database. Ulcer specimens were obtained for testing using a validated multiplex polymerase chain reaction (M-PCR) assay for Treponema pallidum (TP; primary syphilis), Haemophilus ducreyi (chancroid), LGV-associated strains of Chlamydia trachomatis, and herpes simplex virus (HSV) types 1 and 2. Blood samples were collected for testing with HIV, treponemal, and nontreponemal serologic assays. RESULTS: Among 200 GUD patients, 77 (38.5%) were positive for HSV, 32 (16%) were positive for TP, and 2 (1%) were positive for LGV-associated strains of C trachomatis. No H ducreyi infections were detected. No organism was found in 98 (49.5%) of participants. The overall HIV positivity rate was 52.2% for all GUD patients, with higher rates among women compared with men (59.8% vs 45.2%, P < 0.05) and among patients with HSV (68.6% vs 41.8%, P < 0.0001). Among patients with GUD, 54 (27.3%) had gonorrhea and/or chlamydia infection. However, in this latter group, 66.7% of women and 70.0% of men did not have abnormal vaginal or urethral discharge on examination. CONCLUSIONS: Herpes simplex virus is the most common cause of GUD in our survey, followed by T. pallidum. No cases of chancroid were detected. The association of HIV infections with HSV suggests high risk for cotransmission; however, some HSV ulcerations may be due to HSV reactivation among immunocompromised patients. The overall prevalence of gonorrhea and chlamydia was high among patients with GUD and most of them did not meet the criteria for concomitant syndromic management covering these infections.
Assuntos
Doenças dos Genitais Femininos/microbiologia , Doenças dos Genitais Masculinos/microbiologia , Infecções Sexualmente Transmissíveis/microbiologia , Úlcera Cutânea/microbiologia , Adolescente , Adulto , Anti-Infecciosos/uso terapêutico , Coinfecção , Feminino , Doenças dos Genitais Femininos/etiologia , Doenças dos Genitais Masculinos/etiologia , Inquéritos Epidemiológicos , Humanos , Masculino , Saúde Reprodutiva , Infecções Sexualmente Transmissíveis/epidemiologia , Infecções Sexualmente Transmissíveis/etiologia , Úlcera Cutânea/epidemiologia , Úlcera Cutânea/etiologia , Adulto Jovem , Zimbábue/epidemiologiaRESUMO
INTRODUCTION: Symptomatic vaginal discharge is a common gynecological condition managed syndromically in most developing countries. In Zimbabwe, women presenting with symptomatic vaginal discharge are treated with empirical regimens that commonly cover both sexually transmitted infections (STIs) and reproductive tract infections, typically including a combination of an intramuscular injection of kanamycin, and oral doxycycline and metronidazole regimens. This study was conducted to determine the current etiology of symptomatic vaginal discharge and assess adequacy of current syndromic management guidelines. METHODS: We enrolled 200 women with symptomatic vaginal discharge presenting at 6 STI clinics in Zimbabwe. Microscopy was used to detect bacterial vaginosis and yeast infection. Nucleic acid amplifications tests were used to detect Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, and Mycoplasma genitalium. In addition, serologic testing was performed to detect human immunodeficiency virus (HIV) infection. RESULTS: Of the 200 women, 146 (73%) had an etiology detected, including bacterial vaginosis (24.7%); N. gonorrhoeae (24.0%); yeast infection (20.7%); T. vaginalis (19.0%); C. trachomatis (14.0%) and M. genitalium (7.0%). Among women with STIs (N = 90), 62 (68.9%) had a single infection, 18 (20.0%) had a dual infection, and 10 (11.1%) had 3 infections.Of 158 women who consented to HIV testing, 64 (40.5%) were HIV infected.The syndromic management regimen covered 115 (57.5%) of the women in the sample who had gonorrhea, chlamydia, M. genitalium, or bacterial vaginosis, whereas 85 (42.5%) of women were treated without such diagnosis. CONCLUSIONS: Among women presenting with symptomatic vaginal discharge, bacterial vaginosis was the most common etiology, and gonorrhea was the most frequently detected STI. The current syndromic management algorithm is suboptimal for coverage of women presenting with symptomatic vaginal discharge; addition of point of care testing could compliment the effectiveness of the syndromic approach.
Assuntos
Descarga Vaginal/etiologia , Descarga Vaginal/microbiologia , Vaginose Bacteriana/diagnóstico , Adolescente , Adulto , Algoritmos , Infecções por Chlamydia/diagnóstico , Infecções por Chlamydia/epidemiologia , Chlamydia trachomatis/isolamento & purificação , Gerenciamento Clínico , Feminino , Gonorreia/diagnóstico , Gonorreia/epidemiologia , Infecções por HIV/diagnóstico , Infecções por HIV/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Infecções por Mycoplasma/diagnóstico , Infecções por Mycoplasma/epidemiologia , Mycoplasma genitalium/isolamento & purificação , Neisseria gonorrhoeae/isolamento & purificação , Inquéritos e Questionários , Trichomonas vaginalis/isolamento & purificação , Descarga Vaginal/epidemiologia , Vaginose Bacteriana/epidemiologia , Adulto Jovem , Zimbábue/epidemiologiaAssuntos
Antibacterianos/uso terapêutico , Chlamydia trachomatis/genética , Doxiciclina/uso terapêutico , Linfogranuloma Venéreo/tratamento farmacológico , Chlamydia trachomatis/isolamento & purificação , Genótipo , Homossexualidade Masculina , Humanos , Linfogranuloma Venéreo/diagnóstico , Linfogranuloma Venéreo/epidemiologia , Masculino , Guias de Prática Clínica como Assunto , SorotipagemRESUMO
Potential legal liability for practicing expedited partner therapy is a common concern among providers, although it has been uncertain how these concerns translate into clinical practice. This study suggests that providers are more likely to practice expedited partner therapy in more favorable legal environments.
Assuntos
Infecções por Chlamydia/transmissão , Busca de Comunicante/legislação & jurisprudência , Gonorreia/transmissão , Responsabilidade Legal , Padrões de Prática Médica/legislação & jurisprudência , Parceiros Sexuais , Infecções por Chlamydia/história , Infecções por Chlamydia/prevenção & controle , Busca de Comunicante/história , Feminino , Gonorreia/história , Gonorreia/prevenção & controle , Pesquisas sobre Atenção à Saúde , História do Século XXI , Humanos , Responsabilidade Legal/história , Masculino , Imperícia , Aceitação pelo Paciente de Cuidados de Saúde , Padrões de Prática Médica/históriaRESUMO
BACKGROUND: Asymptomatic Chlamydia trachomatis (chlamydia) and Neisseria gonorrhoeae (gonorrhea) infections pose diagnostic and control problems in developing countries. METHODS: Participants in China, India, Peru, Russia, and Zimbabwe were screened for C. trachomatis and N. gonorrhoeae infections and symptoms. RESULTS: A total of 18,014 participants were evaluated at baseline, 15,054 at 12 months, and 14,243 at 24 months. The incidence of chlamydia in men was 2.0 per 100 person years both from baseline to 12 months and from 12 to 24 months, and in women, 4.6 from baseline to 12 months and 3.6 from 12 to 24 months; a range of 31.2% to 100% reported no symptoms across the 5 countries. The incidence of gonorrhea in men was 0.3 per 100 person years both from baseline to 12 months and from 12 to 24 months, and in women, 1.4 from baseline to 12 months and 1.1 from 12 to 24 months; a range of 66.7% to 100% reported no symptoms. Being female, aged 18 to 24 years, and having more than 1 partner were associated with both the infections. In addition, being divorced, separated, or widowed was associated with gonorrhea. Being male, having 6+ years of education, and reporting only 1 partner were associated with having no symptoms among those infected with chlamydia. No variables correlated with asymptomatic gonorrhea among those infected. CONCLUSION: A high prevalence and incidence of asymptomatic sexually transmitted infections was identified among men and women in a wide variety of settings. More effective programs are needed to identify and treat chlamydia and gonorrhea infections, especially among women, young adults, those with multiple partners, those repeatedly infected, and particularly those at risk without symptoms. The risk of transmission from persons with no symptoms requires further study.
Assuntos
Infecções por Chlamydia/epidemiologia , Infecções por Chlamydia/fisiopatologia , Chlamydia trachomatis , Gonorreia/epidemiologia , Gonorreia/fisiopatologia , Neisseria gonorrhoeae , Adolescente , Adulto , China/epidemiologia , Infecções por Chlamydia/diagnóstico , Infecções por Chlamydia/microbiologia , Chlamydia trachomatis/isolamento & purificação , Chlamydia trachomatis/patogenicidade , Feminino , Gonorreia/diagnóstico , Gonorreia/microbiologia , Homossexualidade Masculina , Humanos , Incidência , Índia/epidemiologia , Masculino , Pessoa de Meia-Idade , Neisseria gonorrhoeae/isolamento & purificação , Neisseria gonorrhoeae/patogenicidade , Peru/epidemiologia , Prevalência , Federação Russa/epidemiologia , Profissionais do Sexo , Transexualidade , Adulto Jovem , Zimbábue/epidemiologiaRESUMO
We assessed trends in behavioral risk for HIV infection among men who have sex with men (MSM). Seattle MSM participated in random digit dial telephone surveys in 2003 (n = 400) and 2006 (n = 400). Fourteen percent in 2003 and 9% in 2006 reported unprotected anal intercourse with a partner of different or unknown HIV status (non-concordant UAI; odds ratio [OR] = 0.7; 95% confidence interval [CI]: 0.5, 1.2). Compared to participants in 2003, participants in 2006 met a greater proportion of their anal sex partners through the Internet (OR = 2.0; 95% CI: 1.2, 3.1). Although the proportion of anal sex partnerships formed online increased between 2003 and 2006, Internet partnerships were not more risky than those initiated elsewhere. While the emergence of the Internet as a venue through which men meet partners demonstrates that sexual risk among MSM remains highly dynamic, our findings suggest that sexual risk behavior among MSM is currently stable.