bluuebunny/crossref_metadata_2025_split huggingface dataset:
O02.1 A Randomised, Controlled Study to Assess the Efficacy and Safety of Nifuratel Vaginal Tablets on Bacterial Vaginosis
Authors: Mendling W , Caserini M , Palmieri R 
Published: July 2013

BackgroundBacterial vaginosis (BV) is a polymicrobial infection and the most common cause of vaginal discharge in women during their reproductive years. A randomised, evaluator-blinded, parallel group pivotal study was carried out to assess the efficacy and safety of the local treatment with nifuratel vaginal tablets in comparison with metronidazole vaginal suppositories in premenopausal, non-pregnant women suffering from BV.MethodsA total of 727 adult women in 38 German sites, with BV diagnosed by Amsel and Nugent criteria, were enrolled after providing their written informed consent. Patients received one course of vaginal treatment with metronidazole 100 mg once daily (o.d.) for six days or nifuratel 250 mg o.d. for ten days. The test of cure visit was performed on day 24 ± 3 after the beginning of the treatment. The efficacy was evaluated using the therapeutic cure rate defined as a combined endpoint including Amsel criteria, clinical signs and symptoms and Nugent score evaluated by a blinded central assessor. The non-inferiority of nifuratel compared to metronidazole at the pre-specified margin of Δ-15% was defined as the clinically acceptable difference between the two active treatments.ResultsThe therapeutic cure rate was achieved in the per protocol data set by the 53.7% of women: 54.5% in the nifuratel group and 52.9% in metronidazole treated patients (p = 0.0002). Concerning Nugent score (0–3), the two treatments had similar responder rates: 66.2% nifuratel vs. 66.8% metronidazole (p = 0.0006), same results were obtained in terms of Amsel criteria normalisation 78.9% nifuratel vs. 78.6% metronidazole (p = 0.0001). Nifuratel was slightly better to metronidazole curing vulvovaginal signs and symptoms: 81.2% vs. 78.6% (p < 0.0001).ConclusionThe study results suggest that nifuratel 250 mg vaginal tablet o.d. for 10 days may be recommended as first-line treatment in BV as well as the golden standard metronidazole since their efficacy is comparable.
O02.2 Susceptiblity of Bacterial Vaginosis (BV)-Associated Bacteria and Lactobacilli to Rifaximin, Metronidazole and Clindamycin
Authors: Hillier S L , Cosentino L , Petrina M , Rabe L 
Published: July 2013

ObjectiveRifaximin is a semisynthetic rifamycin with poor oral bioavailability, used as an oral agent for the treatment of traveller’s diarrhoea and hepatic encephalopathy. Rifaximin is in development as a topical agent for the treatment of bacterial vaginosis (BV). The objective of this study was to evaluate the antimicrobial susceptibility of vaginal isolates of facultative and anaerobic bacteria to rifaximin, clindamycin and metronidazole.MethodsA total of 411 unique BV-related bacteria and 100 isolates of lactobacilli recovered from the human vagina of US women during the years 2009–2012 were tested for antimicrobial susceptibility by the agar dilution CLSI reference method to calculate MICs.ResultsOverall, 142 (35%) of the BV-associated vaginal isolates tested were resistant to metronidazole, 63 (15%) were resistant to clindamycin and 11 (2.6%) were resistant to rifaximin. Metronidazole resistance was observed most frequently amongGardnerella vaginalis(n = 100 isolates, 69% resistant),Atopobium vaginae(n = 62, 87% resistant) andMobiluncus(n = 40, 42% resistant), whereas most were susceptible to both clindamycin (197/202; 98% susceptible) and rifaximin (191/202; 95% susceptible). Both rifaximin and metronidazole were effective against all strains ofPrevotella bivia(n = 34),P timonensis(n = 33),Anaerococcus tetradius(n = 21), Finegoldia magna(n = 20) andPeptoniphilus lacrimalis(n = 20), whereas clindamycin resistance was detected among 74%, 42%, 19%, 30% and 30% of these anaerobes isolates, respectively. More than 90% ofPrevotella amnii(n = 33),Peptoniphilus harei(n = 23) andMegasphaera-like bacteria (n = 25) were susceptible to all three antibiotics. As expected, none of theLactobacillusisolates were susceptible to metronidazole, whereas a majority were susceptible to both clindamycin and rifaximinin vitro.ConclusionRifaximin had MIC values for a range of microorganisms associated with BV which were superior or similar to the other two drugs approved for the treatment of this condition and deserves clinical evaluation as a new therapeutic agent for the treatment of BV.
O02.4 Persistent/Recurrent Chlamydial Infection Among STD Clinic Patients Treated with CDC-Recommended Therapies
Authors: Khosropour C M , Duan R , Metsch L R , Feaster D J , Golden M R 
Published: July 2013

BackgroundCDC guidelines recommend azithromycin or doxycycline as treatments for chlamydial infection. Recently, one randomised trial comparing these therapies suggested doxycycline was superior, while another found the two therapies were equivalent. We examined the risk of persistent/recurrent chlamydial infection among patients treated with doxycycline or azithromycin.MethodsWe performed a secondary analysis of data from Project Aware, a randomised, controlled trial of a behavioural intervention. The trial enrolled patients aged ≥ 18 years without a prior HIV diagnosis in 9 U.S. STD clinics in 2010. At baseline, women with urogenital chlamydial infection and men with urethral and/or rectal chlamydial infections were treated with azithromycin or doxycycline, per clinic standard of care. Patients with a positive chlamydia test at 6-month follow-up were considered to have persistent/recurrent infection.ResultsOf 5012 participants, 492 (9.8%) tested positive forC. trachomatisat baseline. Of these, 338 (69%) were treated with doxycycline or azithromycin without a second drug active againstC. trachomatis; 92% (76 of 83) and 88% (225 of 255), respectively, were re-tested at 6 months. Comparing doxycycline and azithromycin, overall 7 (9.2%) and 26 (11.6%), respectively, had persistent/recurrent infection (RR = 0.80, 95% CI = 0.36–1.76). Among persons with urogenital infections, 6 (10.0%) of 60 and 18 (10.1%) of 179 (RR = 0.99, 95% CI = 0 0.41–2.39), respectively had persistent/recurrent infection. Among men with rectal infections, 2 (9.5%) of 21 and 8 (16.3%) of 49 who received doxycycline and azithromycin, respectively, had persistent/recurrent infection (RR = 0.58, 95% CI = 0.14–2.52). On multivariate analysis, persistent/recurrent infection was significantly associated with black (vs. white) race (aRR = 4.29, 95% CI = 1.14–16.16) and rectal (vs. urogenital) infection (aRR = 5.42, 95% CI = 0.99–29.55), but not treatment regimen.ConclusionThere were no differences in persistent/recurrent urogenital chlamydia infections at six months by treatment type. Treatment failure of rectal infections among men may be more common with azithromycin and merits additional study.
O03.1 Risk Factors For Antimicrobial ResistantNeisseria Gonorrhoeaein Europe
Authors: Cole M J , Spiteri G , Town K , Unemo M , Hoffmann S , Laar M van de , Ison C 
Published: July 2013

IntroductionThe European Centre for Disease Prevention and Control is responsible for the enhanced surveillance of sexually transmitted infections and co-ordinates the European gonococcal antimicrobial surveillance programme (Euro-GASP) in the European Union and the European Economic Area. Linked patient and antimicrobial susceptibility data from Euro-GASP allows those at risk of acquiring antimicrobial resistantNeisseria gonorrhoeaeto be identified.MethodsSeventeen countries in 2009 and 21 countries in 2010 and 2011 submitted gonococcal isolates to Euro-GASP, which were tested by Etest or agar dilution for cefixime, ceftriaxone, ciprofloxacin, azithromycin, spectinomycin and gentamicin. Additional patient data linked to the gonococcal isolates susceptibility profiles was collected. All three years antimicrobial susceptibility data and linked patient data were combined. Patient variables associated with resistance were established using a univariate and multivariable analyses of odds ratios. Geometric means for ceftriaxone and cefixime MICs were calculated.ResultsA total of 5034 gonococcal isolates were tested in Euro-GASP from 2009 to 2011. In the multivariable analysis heterosexuals (males only for ciprofloxacin), older patients and those without a concurrent chlamydia infection remained significantly more likely to be infected with isolates displaying cefixime decreased susceptibility and ciprofloxacin resistance. The geometric mean of cefixime and ceftriaxone MICs decreased from 2009 to 2011, most significantly for MSM; MSM had lower geometric means than heterosexuals in 2011. A bimodal MIC distribution of a ‘more susceptible’ and ‘less susceptible’ gonococcal population appears to be emerging alongside this geometric mean decrease.ConclusionThis Euro-GASP data suggests that the burden of gonococcal antimicrobial resistance is more prevalent among heterosexuals and decreasing in MSM. This study shows the importance of collecting and analysing patient data along with susceptibility data, however improved data numbers and representativeness is required before any focused treatments or public health intervention strategies are initiated.Abstract O03.1 Table 1Patient risk factors for antimicrobial resistance (OR, 95% CI from multivariable analysis)Cefixime decreased susceptibilityCiprofloxacin resistanceMSM11Male heterosexuals2.39 (1.58–3.61)*1.49 (1.21–1.83)*Female2.75 (1.68–4.5)*1.04 (0.8–1.34)< 25 years11≥ 25 years2.07 (1.36–3.13)*1.67 (1.37–2.05)*Chlamydia - yes11Chlamydia - no1.87(1.1–3.16)*2.2 (1.74–2.8)**P value < 0.05 (from the Pearson Chi2-test)
O03.3 Maximising the Efficiency of Gonorrhoea Treatment by Targeting the Use of Previous First Line Therapies to Susceptible Patients
Authors: Town K , Obi C , Chisholm S , Hughes G , Ison C A 
Published: July 2013

BackgroundGonorrhoea treatment guidelines change when less than 95% of the infected population is successfully treated with the recommended antimicrobial. Isolates with decreased susceptibility to ceftriaxone, the current recommended therapy, have been identified and if treatment failure becomes problematic there are no new antimicrobials approved. However,Neisseria gonorrhoeaeremains susceptible to penicillin, ciprofloxacin and cefixime in at least two thirds of patients (82%, 68%, and 98% respectively) so it may be possible to target previously recommended antimicrobials to specific population sub-groups.MethodsDescriptive data from the Gonococcal Resistance to Antimicrobials Surveillance Programme (GRASP) were analysed for trends in penicillin, ciprofloxacin and cefixime susceptibility across patient sub-groups. Patient characteristics associated with antimicrobial susceptibility were identified using univariate and multivariable analyses. All analyses were performed separately for heterosexuals and men who have sex with men (MSM).ResultsHeterosexual patients whose infection was susceptible to penicillin, ciprofloxacin or cefixime were of black ethnicity, penicillin: 94%, adjusted odds ratio (OR) 3.52 (95% confidence interval (CI) 2.62–4.72), ciprofloxacin: 92%, OR 5.35 (CI 4.08–7.0), cefixime: 99%, OR 3.62 (CI 1.91–6.84), or with concurrent chlamydia infection (penicillin: 94%, 2.34, 1.75–3.13, ciprofloxacin: 92%, 3.37, 2.59–4.38, cefixime: 99%, 2.32, 1.23–4.39). Additionally isolates susceptible to penicillin were found in patients aged 13–24 years (92%, 3.54, 2.63–4.77) or without symptoms (92%, 1.75, 1.28–2.4). All isolates from heterosexuals were fully susceptible to cefixime. In all sub-groups of the MSM population the proportion of isolates susceptible to penicillin, ciprofloxacin or cefixime was below 90%.ConclusionThe efficiency of gonorrhoea treatment could be maximised by targeting the use of previous first line therapies to specific heterosexual population sub-groups if the treatment threshold is reduced to 90%. Treatment of any MSM with penicillin, ciprofloxacin or cefixime would not be appropriate, as the proportion susceptible to these antimicrobials is much less than for the heterosexual population.
O03.4 Genomic Epidemiology of Neisseria Gonorrhoeae with Reduced Susceptibility to Cefixime in the United States
Authors: Grad Y H , Kirkcaldy R , Trees D , Dordel J , Goldstein E , Weinstock H , Parkhill J , Hanage W P , Bentley S , Lipsitch M 
Published: July 2013

BackgroundGenome sequencing of pathogens has yielded insights into transmission networks and the spread of antibiotic resistance. Here, we report a large-scale genomic epidemiology study ofNeisseria gonorrhoeaeto investigate the emergence and spread of isolates with reduced susceptibility to cephalosporins.MethodsWe sequenced the genomes of 242 gonococcal isolates collected by CDC’s Gonococcal Isolate Surveillance Program (GISP). These isolates comprise all 141 isolates from GISP in 2009–10 with reduced susceptibility to cefixime (cefRS; cefixime MICs ≥ 0.25 µg/ml) and 141 susceptible isolates matched by location, collection date, and sexual orientation of the infected individual. We assessed diversity and association of genes known to contribute to antibiotic resistance, correlated location and phylogenetic clustering to determine sexual networks, and characterised the extent of recombination.ResultsPhylogenetic analysis of single nucleotide polymorphisms (SNPs) within the core genome (34959 SNPs) demonstrates that most cefRSisolates in the US fall into two distinct lineages. We identify several independent acquisitions of a mosaicpenAallele, including evidence of a partial mosaic in an isolate with cefRSand of reversion to an allele conferring cephalosporin susceptibility. Correlating the phylogeny with sexual orientation and geographic location provides evidence for clones circulating in sexual networks, some of which appear geographically restricted and others widespread. Analysis of predicted recombinant regions shows evidence of exchange with otherNeisseriaspp., consistent with prior observations of interspecies mosaicism.ConclusionsCefRSisolates in the US predominantly derive from two lineages that share the same mosaicpenAsequence, and reflect sexual networks at local and regional scales. Additionally, we quantify the extent of recombination and the correlation of selected alleles with resistance phenotypes. Genomic methods offer detailed insights into the spread of resistant infections, with potential for enhanced surveillance and improved diagnostics.
O03.5 Recent Increases in Gonorrhoea in Europe
Authors: Spiteri G , Haar K , Sfetcu O , Laar M van de 
Published: July 2013

BackgroundRecent reports have described increasing trends of gonorrhoea among men who have sex with men (MSM) in the United Kingdom and women in Sweden. European Union (EU/EEA) surveillance data has also shown increasing rates of gonorrhoea since 2008. We analysed surveillance data to identify the contributions of key populations to this increase.MethodsSurveillance of gonorrhoea in the EU/EEA is co-ordinated by the European Centre for Disease Prevention and Control (ECDC). Data reported to ECDC in 2008 and 2011 were compared, focusing on countries with an increasing number of gonorrhoea cases, to analyse changes among key populations.ResultsIn 2011, 39 179 cases of gonorrhoea were reported from 28 EU/EEA countries. Of these countries, 21 reported a median increase in the number of reported cases of 31% (interquartile range: 22–79%). Among countries reporting increasing cases, 15–24 year olds accounted for 43% of reports in 2011; males accounted for 72%; MSM for 40%. Among MSM, the largest proportion of cases was reported among 25–34 year olds (42%).Between 2008 and 2011, the number of reported cases increased by 37%. Increases were observed among all age-groups, particularly among 25–34 year olds (61%) and those aged 45+ (78%). Reported cases increased by 51% among males compared to 30% among females. Transmission among MSM increased by 124% since 2008 and, among MSM, the largest increase in reported cases was among those aged 45+ (192%) and 25–34 year olds (173%).ConclusionsAlthough reported cases of gonorrhoea increased among all age-groups and both genders between 2008 and 2011, the highest increase occurred among MSM above 25 years of age. Increasing trends may be due to increased awareness and testing, and improved reporting; increased transmission, however, is also likely. Prevention messages targeting these groups need to be reinforced.
O03.6 Using Molecular Typing to Investigate N. Gonorrhoeae Strain Turnover: A Comparative Study of GISP Isolates Collected from Baltimore and San Francisco
Authors: Espinosa K , Gerrity J , Pandori M , Marsiglia V , Hardick J , Barnes M , Hess D , Gaydos C 
Published: July 2013

BackgroundOne internationally accepted method for the molecular epidemiologic typing ofNeisseria gonorrhoeaeisNeisseria gonorrhoeaeMulti Antigen Sequence Typing (NG-MAST). NG-MAST utilises DNA sequencing of two variable regions of theN. gonorrhoeaegenome to classify gonococcal isolates into strain types.MethodWe assessed the genetic diversity ofN. gonorrhoeaeisolates in Baltimore (N = 277) spanning the years 2009–2011 compared to San Francisco (N = 539) from 2005–2011, using NG-MAST. All isolates in this project were obtained from the CDC Gonococcal Isolate Surveillance Project (GISP). San Francisco strains were mostly from MSM, while the Baltimore isolates were mostly from a heterosexual population.ResultsNG-MAST results from isolates across that time period revealed a surprising degree of sequence type turnover within the Baltimore area. When compared to the data from San Francisco, theN. gonorrhoeaegenetic diversity trends revealed minimal overlap in sequence families between the two metropolitan areas; SF8238, SF210, and SF 2992 were present in both populations. However, a pair-wise comparison of other strain families revealed two relatively distinct populations; the most prevalent strain families in San Francisco were SF437, SF23, SF3935, and SF1407, while those in Baltimore were SF8234, SF8240, SF865, and SF8262.ConclusionThese data may imply that the traditional understanding of a gonococcal transmission pattern from west to east cannot accurately depict the strain flow ofN. gonorrhoeaeisolates within these populations. Our data revealed a large amount of strain turnover in both metropolitan areas by year. This raises questions about the entry and transmission ofN. gonorrhoeaewithin the U.S., and the implications of this turnover in regards to the evolution of this organism.
O04.1 The Influence of Hormonal Contraception and Pregnancy on the Vaginal Microbiome, Sexually Transmitted Infections, and Cytokine Responses in a Cohort of Rwandan Sex Workers
Authors: Verwijs M C , Borgdorff H , Wit F W N M , Schuren F H , Lutter R , Verhelst R , Bonten M J M , Wijgert J H H M van de 
Published: July 2013

BackgroundThe effects of hormonal contraception and pregnancy on the vaginal microbiome (by molecular methods), acquisition and persistence of sexually transmitted infections (STIs), and genitourinary mucosal immunology are still largely unknown.MethodsHIV-negative, non-pregnant female sex workers (n = 397) in Kigali, Rwanda, were followed for two years. Demographic, behavioural, clinical, STI and pregnancy data were collected at regular intervals. The vaginal microbiome was cross-sectionally determined using a phylogenetic microarray (n = 174). Women with STIs were purposefully oversampled in this subsample. Inflammatory cytokines were measured in cervicovaginal fluid using Luminex and ELISA methodology (n = 343). Hormonal exposure was defined as use of hormonal contraception (oral or injectable) or a positive urine pregnancy test. Women in the exposure groups were compared to non-pregnant women who did not use hormonal contraception. Adjustments were made for demographic data and sexual risk taking.ResultsAt baseline, 12% of the women used hormonal injectables, and 6% oral contraceptives (OC); 7.7% was pregnant. OC use was associated with higher HPV prevalence (aOR 3.09; 95% CI 1.42–7.72), higherChlamydia trachomatisincidence (aOR 7.13; 95% CI 1.40–36.30), and lower syphilis prevalence (0% vs 7.2% in controls) and incidence (0% vs 1.2%). Hormonal injectables were associated with higher HSV-2 prevalence (aOR 2.08; 95% CI 1.23–3.50). Pregnancy was weakly associated with higherTrichomonas vaginalis(aOR 1.67; 95% CI 0.97–2.88) and vaginal yeast (aOR 1.95; 95% CI 0.99–3.82) incidence. Six vaginal microbiome clusters were identified. No associations between hormonal exposure status and vaginal microbiome clusters were found; however, pregnant women had lowerGardnerella vaginalislevels. Pregnant women had higher IL-8 levels in cervicovaginal fluids than non-exposed women.ConclusionsBoth hormonal contraception and pregnancy were associated with higher STI incidence. Overall, vaginal inflammation and microbiome composition were similar among groups, but pregnant women had lowerGardnerellaand higher IL-8 levels.
O04.2 Hormonal Contraception is Associated with a Reduced Risk of Bacterial Vaginosis: A Systematic Review and Meta-Analysis
Authors: Vodstrcil L A , Hocking J S , Law M , Walker S , Fairley C K , Tabrizi S , Bradshaw C S 
Published: July 2013

BackgroundWe conducted a systematic review and meta-analysis of published data to examine the association between hormonal contraception (HC) and bacterial vaginosis (BV).MethodsThree databases (Medline, Web of Science and Embase) were searched until the end of January 2013 and duplicate references removed. Inclusion criteria were (1) > 20 BV cases; (2) data available to derive the association between HC and BV; (3) > 10% of participants used HC; (4) accepted BV diagnostic method. Data extracted included: type of HC, BV diagnostic method, and BV outcome (prevalent, incident, recurrent). Meta-analyses were conducted to calculate overall and pooled odds/risk ratios (OR/RR), stratified by HC-type and BV outcome. This systematic review is registered with PROSPERO (CRD42013003699).ResultsOf 1710 unique references identified, 328 were assessed for eligibility and 48 studies met inclusion criteria. Overall, 36 reported BV-prevalence, 12 BV-incidence and 3 BV-recurrence. Twenty three studies reported data for combined-HC, 9 for progesterone-only HC and 23 did not specify HC-type. Diagnostic methods included: Nugent’s (n = 31), Amsel’s (n = 15), Spiegel’s (n = 1) and Ison-Hay (n = 1). Pooled BV prevalence was 30.7% (95% CI: 26.7–34.7%) and ranged from 4.7%–66.7%, with > 99% of the observed variance of prevalent BV explained by heterogeneity (I2 = 99.6%). The pooled effect of any HC-use on the composite-BV outcome (prevalent/incident/recurrent) was OR = 0.67 (95% CI: 0.62–0.71). When stratified by BV outcome, any HC-use was associated with decreased risk of prevalent (OR = 0.63; 0.58–0.68), incident (RR = 0.78; 0.68–0.87) and recurrent (RR = 0.61; 0.49–0.73) BV. When prevalent BV was stratified by HC-type, combined-HC (OR = 0.68; 0.62–0.74), unspecified HC-type (OR = 0.60; 0.53–0.67), and progesterone-only methods (OR = 0.67; 0.46–0.88) were all associated with decreased risk of prevalent BV.ConclusionHC-use is associated with a significant and consistent decreased risk of all BV outcomes, with a greater reduction in risk for prevalent than incident BV. Surprisingly, both combined and progesterone-only contraceptive methods were associated with reduced risk of prevalent BV.