Mycoplasma genitalium Prevalence, Coinfection, and Macrolide Antibiotic Resistance Frequency in a Multicenter Clinical Study Cohort in the United States

The prevalence rates ofMycoplasma genitaliuminfections and coinfections with other sexually transmitted organisms and the frequency of a macrolide antibiotic resistance phenotype were determined in urogenital specimens collected from female and male subjects enrolled in a multicenter clinical study in the United States. Specimens from 946 subjects seeking care from seven geographically diverse clinical sites were tested forM. genitaliumand forChlamydia trachomatis,Neisseria gonorrhoeae, andTrichomonas vaginalis. Sequencing was used to assess macrolide antibiotic resistance amongM. genitalium-positive subjects.M. genitaliumprevalence rates were 16.1% for females and 17.2% for males. Significant risk factors forM. genitaliuminfections were black race, younger age, non-Hispanic ethnicity, and female symptomatic status. FemaleM. genitaliuminfections were significantly more prevalent thanC. trachomatisandN. gonorrhoeaeinfections, while theM. genitaliuminfection rate in males was significantly higher than theN. gonorrhoeaeandT. vaginalisinfection rates. The macrolide-resistant phenotype was found in 50.8% of females and 42% of males. These results show a high prevalence ofM. genitaliumsingle infections, a lower prevalence of coinfections with other sexually transmitted organisms, and high rates of macrolide antibiotic resistance in a diverse sample of subjects seeking care across a wide geographic area of the United States.

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Molecular Testing for Mycoplasma genitalium in the United States: Results from the AMES Prospective Multicenter Clinical Study

Journal of Clinical Microbiology ◽

10.1128/jcm.01125-19 ◽

2019 ◽

Vol 57 (11) ◽

Cited By ~ 9

Author(s):

Charlotte A. Gaydos ◽

Lisa E. Manhart ◽

Stephanie N. Taylor ◽

Rebecca A. Lillis ◽

Edward W. Hook ◽

...

Keyword(s):

United States ◽

Clinical Study ◽

Reference Method ◽

Mycoplasma Genitalium ◽

The United States ◽

23S Rrna ◽

Molecular Testing ◽

Content Type ◽

Vaginal Swabs ◽

Multicenter Clinical Study

ABSTRACT A prospective multicenter clinical study involving subjects from 21 sites across the United States was conducted to validate the performance of a new in vitro diagnostic nucleic acid amplification test (NAAT) for the detection of Mycoplasma genitalium. Seven urogenital specimen types (n = 11,556) obtained from 1,778 females, aged 15 to 74 years, and 1,583 males, aged 16 to 82 years, were tested with the Aptima Mycoplasma genitalium assay, an investigational transcription-mediated amplification (TMA) NAAT for the detection of M. genitalium 16S rRNA. Infected status for enrolled subjects was established using results obtained from testing either self-collected vaginal swab or clinician-collected male urethral swab specimens with a composite reference method consisting of three transcription-mediated amplification NAATs targeting unique regions of M. genitalium 16S or 23S rRNA. M. genitalium prevalence was 10.2% in females and 10.6% in males; prevalence was high in both symptomatic and asymptomatic subjects for both sexes. Compared to the subject infected status standard, the investigational test had sensitivity and specificity estimates, respectively, of 98.9% and 98.5% for subject-collected vaginal swabs, 92.0% and 98.0% for clinician-collected vaginal swabs, 81.5% and 98.3% for endocervical swabs, 77.8% and 99.0% for female urine, and 98.2% and 99.6% for male urethral swabs, 88.4% and 97.8% for self-collected penile meatal swabs, and 90.9% and 99.4% for male urine specimens. For all seven specimen types, within-specimen positive and negative agreements between the investigational test and the composite reference standard ranged from 94.2% to 98.3% and from 98.5 to 99.9%, respectively. These results provide clinical efficacy evidence for the first FDA-cleared NAAT for M. genitalium detection in the United States.

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Mycoplasma genitalium Detection in Urogenital Specimens from Symptomatic and Asymptomatic Men and Women by Use of the cobas TV/MG Test

Journal of Clinical Microbiology ◽

10.1128/jcm.02124-19 ◽

2020 ◽

Vol 58 (6) ◽

Cited By ~ 1

Author(s):

Barbara Van Der Pol ◽

Ken B. Waites ◽

Li Xiao ◽

Stephanie N. Taylor ◽

Arundhati Rao ◽

...

Keyword(s):

United States ◽

Trichomonas Vaginalis ◽

Mycoplasma Genitalium ◽

The United States ◽

Clinical Samples ◽

Men And Women ◽

Content Type ◽

Sexually Transmitted ◽

Asymptomatic Individuals ◽

Asymptomatic Men

ABSTRACT Mycoplasma genitalium (MG) infections are a growing concern within the field of sexually transmitted infections. However, diagnostic assays for M. genitalium have been limited in the United States. As most infections are asymptomatic, individuals can unknowingly pass the infection on, and the prevalence is likely to be underestimated. Diagnosis of M. genitalium infection is recommended using a nucleic acid test. This multicenter study assessed the performance of the cobas Trichomonas vaginalis (TV)/MG assay (cobas) for the detection of M. genitalium, using 22,150 urogenital specimens from both symptomatic and asymptomatic men and women collected at geographically diverse sites across the United States. The performance was compared to a reference standard of three laboratory-developed tests (LDTs). The specificity of the cobas assay for M. genitalium ranged from 96.0% to 99.8% across symptomatic and asymptomatic men and women. The sensitivities in female vaginal swabs and urine samples were 96.6% (95% confidence interval [CI], 88.5 to 99.1%) and 86.4% (95% CI, 75.5 to 93.0%), respectively. The sensitivities in male urine and meatal swab samples were 100% (95% CI, 94.0 to 100%) and 85.0% (95% CI, 73.9 to 91.9%), respectively. This study demonstrated that the cobas assay was highly sensitive and specific in all relevant clinical samples for the detection of M. genitalium.

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Levels ofMycoplasma genitaliumAntimicrobial Resistance Differ by Both Region and Gender in the State of Queensland, Australia: Implications for Treatment Guidelines

Journal of Clinical Microbiology ◽

10.1128/jcm.01555-18 ◽

2019 ◽

Vol 57 (3) ◽

Cited By ~ 15

Author(s):

E. L. Sweeney ◽

E. Trembizki ◽

C. Bletchly ◽

C. S. Bradshaw ◽

A. Menon ◽

...

Keyword(s):

Antibiotic Resistance ◽

Treatment Guidelines ◽

Mycoplasma Genitalium ◽

Macrolide Resistance ◽

Quinolone Resistance ◽

Resistance Mutations ◽

Transmitted Infection ◽

Content Type ◽

Sexually Transmitted ◽

And Gender

ABSTRACTMycoplasma genitaliumis frequently associated with urogenital and rectal infections, with the number of cases of macrolide-resistant and quinolone-resistantM. genitaliuminfection continuing to increase. In this study, we examined the levels of resistance to these two common antibiotic treatments in geographically distinct locations in Queensland, Australia. Samples were screened for macrolide resistance-associated mutations using a commercially available kit (ResistancePlus MG; SpeeDx), and quinolone resistance-associated mutations were identified by PCR and DNA sequencing. Comparisons between antibiotic resistance mutations and location/gender were performed. The levels ofM. genitaliummacrolide resistance were high across both locations (62%). Quinolone resistance mutations were found in ∼10% of all samples, with a number of samples harboring mutations conferring resistance to both macrolides and quinolones. Quinolone resistance was higher in southeast Queensland than in north Queensland, and this was consistent in both males and females (P = 0.007). TheM. genitaliumisolates in rectal swab samples from males harbored high levels of macrolide (75.9%) and quinolone (19%) resistance, with 15.5% harboring resistance to both classes of antibiotics. Overall, the lowest observed level of resistance was to quinolones in females from north Queensland (1.6%). These data highlight the high levels of antibiotic resistance inM. genitaliumisolates within Queensland and the challenges faced by sexually transmitted infection clinicians in managing these infections. The data do, however, show that the levels of antibiotic resistance may differ between populations within the same state, which has implications for clinical management and treatment guidelines. These findings also support the need for ongoing antibiotic resistance surveillance and tailored treatment.

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Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: Results from a Prospective Multicenter Clinical Study

Journal of Clinical Microbiology ◽

10.1128/jcm.01643-19 ◽

2019 ◽

Vol 58 (2) ◽

Cited By ~ 4

Author(s):

Jane R. Schwebke ◽

Stephanie N. Taylor ◽

Ronald Ackerman ◽

Robert Schlaberg ◽

Neil B. Quigley ◽

...

Keyword(s):

Clinical Study ◽

Bacterial Vaginosis ◽

Sensitivity And Specificity ◽

Significant Proportion ◽

The United States ◽

Species Group ◽

Diagnostic Methods ◽

Content Type ◽

Multicenter Clinical Study

ABSTRACT Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis accounts for a significant proportion of all gynecologic visits in the United States. A prospective multicenter clinical study was conducted to validate the performance of two new in vitro diagnostic transcription-mediated amplification nucleic acid amplification tests (NAATs) for diagnosis of BV, VVC, and trichomoniasis. Patient- and clinician-collected vaginal-swab samples obtained from women with symptoms of vaginitis were tested with the Aptima BV and Aptima Candida/Trichomonas vaginitis (CV/TV) assays. The results were compared to Nugent (plus Amsel for intermediate Nugent) scores for BV, Candida cultures and DNA sequencing for VVC, and a composite of NAAT and culture for T. vaginalis. The prevalences of infection were similar for clinician- and patient-collected samples: 49% for BV, 29% for VVC due to the Candida species group, 4% for VVC due to Candida glabrata, and 10% for T. vaginalis. Sensitivity and specificity estimates for the investigational tests in clinician-collected samples were 95.0% and 89.6%, respectively, for BV; 91.7% and 94.9% for the Candida species group; 84.7% and 99.1% for C. glabrata; and 96.5% and 95.1% for T. vaginalis. Sensitivities and specificities were similar in patient-collected samples. In a secondary analysis, clinicians’ diagnoses, in-clinic assessments, and investigational-assay results were compared to gold standard reference methods. Overall, the investigational assays had higher sensitivity and specificity than clinicians’ diagnoses and in-clinic assessments, indicating that the investigational assays were more predictive of infection than traditional diagnostic methods. These results provide clinical-efficacy evidence for two in vitro diagnostic NAATs that can detect the main causes of vaginitis.

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Draft Genomic Sequences of Campylobacter coli Isolates from Chicken Carcasses

Microbiology Resource Announcements ◽

10.1128/mra.00564-19 ◽

2019 ◽

Vol 8 (28) ◽

Cited By ~ 1

Author(s):

Aixia Xu ◽

Aisha Abdul-Wakeel ◽

Nereus W. Gunther ◽

Christopher Sommers

Keyword(s):

United States ◽

Antibiotic Resistance ◽

Virulence Factors ◽

The United States ◽

Genomic Sequences ◽

Campylobacter Coli ◽

Foodborne Illnesses ◽

Content Type

Campylobacter bacteria are one of the leading causes of bacterial foodborne illnesses in the United States. Here, we report the draft genomic sequences of eight Campylobacter coli isolates from chicken carcasses, including virulence factors and antibiotic resistance.

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Antibacterial Resistance in Ureaplasma Species and Mycoplasma hominis Isolates from Urine Cultures in College-Aged Females

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.01104-17 ◽

2017 ◽

Vol 61 (10) ◽

Cited By ~ 16

Author(s):

Marissa A. Valentine-King ◽

Mary B. Brown

Keyword(s):

United States ◽

Antibiotic Resistance ◽

Pcr Amplification ◽

Tetracycline Resistance ◽

Mycoplasma Hominis ◽

The United States ◽

Resistant Isolate ◽

Content Type ◽

Tract Infections ◽

First Time

ABSTRACT Urinary tract infections (UTIs) affect nearly 20% of women age 15 to 29 and account for an estimated $3.5 billion in costs. Antibiotic resistance prolongs UTI treatment, and resistance profiles vary regionally. This regional variation is an important consideration in guiding empirical treatment selection. Regional studies in the United States have identified tetracycline resistance in over one-third of Ureaplasma species isolates, but no studies have evaluated antibiotic resistance levels in college-aged women with a first-time UTI. We tested a panel of antibiotics and determined the MICs of Ureaplasma species (60 U. parvum and 13 U. urealyticum) and 10 Mycoplasma hominis isolates obtained from urine from college-aged women with a first-time UTI. Low antibiotic resistance was found in this population of women with a first-time UTI. All M. hominis and U. urealyticum isolates were sensitive. However, two U. parvum isolates were resistant, with one to levofloxacin (MIC, 4 μg/ml) and one to tetracycline (MIC, 8 μg/ml). For the Ureaplasma spp., the MIC90s were highest against gentamicin (21 μg/ml) and lowest against doxycycline (0.25 μg/ml). In a comparison of MIC levels between Ureaplasma spp., U. urealyticum had significantly higher MICs against each antibiotic except doxycycline. For the resistant isolates, the genetic mechanisms of resistance were determined. PCR amplification identified tetM to be present in the tetracycline-resistant isolate and an S83W mutation within the parC gene of the quinolone-resistant isolate. To our knowledge, this study is the first to provide molecular and phenotypic evidence of the S83W parC mutation conferring levofloxacin resistance in U. parvum isolated from a patient in the United States.

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Characteristics of Mycoplasma genitalium Urogenital Infections in a Diverse Patient Sample from the United States: Results from the Aptima Mycoplasma genitalium Evaluation Study (AMES)

Journal of Clinical Microbiology ◽

10.1128/jcm.00165-20 ◽

2020 ◽

Vol 58 (7) ◽

Cited By ~ 1

Author(s):

Lisa E. Manhart ◽

Charlotte A. Gaydos ◽

Stephanie N. Taylor ◽

Rebecca A. Lillis ◽

Edward W. Hook ◽

...

Keyword(s):

United States ◽

Mycoplasma Genitalium ◽

Evaluation Study ◽

The United States ◽

Nucleic Acid Amplification ◽

Content Type ◽

Urogenital Infections ◽

Asymptomatic Individuals ◽

Urogenital Symptoms

ABSTRACT Data from a large prospective multicenter clinical validation study of a nucleic acid amplification in vitro diagnostic test for Mycoplasma genitalium were analyzed to describe the prevalence of M. genitalium infection, risk factors, and disease associations in female and male patients seeking care in diverse geographic regions of the United States. Among 1,737 female and 1,563 male participants, the overall prevalence of M. genitalium infection was 10.3% and was significantly higher in persons ages 15 to 24 years than in persons ages 35 to 39 years (for females, 19.8% versus 4.7% [odds ratio {OR} = 5.05; 95% confidence interval {CI} = 3.01 to 8.46]; for males, 16.5% versus 9.4% [OR = 1.91; 95% CI = 1.20 to 3.02]). The risk for M. genitalium infection was higher in black than in white participants (for females, 12.0% versus 6.8% [OR = 1.88; 95% CI = 1.30 to 2.72]; for males, 12.9% versus 6.9% [OR = 2.02; 95% CI = 1.38 to 2.96]) and higher in non-Hispanic than in Hispanic participants (for females, 11.2% versus 6.0% [OR = 1.97; 95% CI = 1.25 to 3.10]; for males, 11.6% versus 6.8% [OR = 1.80; 95% CI = 1.14 to 2.85]). Participants reporting urogenital symptoms had a significantly elevated risk of M. genitalium infection compared to that for asymptomatic individuals (for females, OR = 1.53 [95% CI = 1.09 to 2.14]; for males, OR = 1.42 [95% CI = 1.02 to 1.99]). Women diagnosed with vaginitis and cervicitis had a higher prevalence of M. genitalium infection than women without those diagnoses, although this was statistically significant only for vaginitis (for vaginitis, OR = 1.88 [95% CI = 1.37 to 2.58]; for cervicitis, OR = 1.42 [95% CI = 0.61 to 2.96]). A diagnosis of urethritis in men was also significantly associated with M. genitalium infection (OR = 2.97; 95% CI = 2.14 to 4.13). Few characteristics distinguished asymptomatic from symptomatic M. genitalium infections. These results from persons seeking care in the United States suggest that M. genitalium infection should be considered in young persons presenting with urogenital symptoms.

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Antibiotic Resistance among Urinary Isolates from Female Outpatients in the United States in 2003 and 2012

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.02897-15 ◽

2016 ◽

Vol 60 (5) ◽

pp. 2680-2683 ◽

Cited By ~ 57

Author(s):

Guillermo V. Sanchez ◽

Ahmed Babiker ◽

Ronald N. Master ◽

Tony Luu ◽

Anisha Mathur ◽

...

Keyword(s):

United States ◽

Antibiotic Resistance ◽

Age Groups ◽

The United States ◽

Antibiotic Activity ◽

Surveillance Network ◽

Content Type ◽

E Coli ◽

Elderly Outpatients ◽

Urinary Isolates

ABSTRACTA retrospective analysis was performed using The Surveillance Network, USA, to examine the prevalence of antibiotic resistance among urine isolates from U.S. female outpatients in 2012 and assessed trends in antibiotic resistance comparing data from 2003 and 2012. The most common pathogen identified in 2012 (n= 285,325) wasEscherichia coli(64.9% of isolates). In 2012,E. coliresistance to nitrofurantoin was low (<3%) across all age groups.E. coliresistance to ciprofloxacin was high among adults (11.8%) and elderly outpatients (29.1%). When comparing the 2003 and 2012 data from isolates from adults,E. coliresistance to nitrofurantoin changed only slightly (from 0.7% to 0.9%), whereas increases in resistance to ciprofloxacin (3.6% to 11.8%) and trimethoprim-sulfamethoxazole (17.2% to 22.2%) changed substantially. In the United States,E. colihas become increasingly resistant to ciprofloxacin and trimethoprim-sulfamethoxazole (TMP-SMX) in adult female outpatients. Nitrofurantoin retains high levels of antibiotic activity against urinaryE. coli.

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