Dataset Information

Effectiveness of sitafloxacin monotherapy for quinolone-resistant rectal and urogenital Mycoplasma genitalium infections: a prospective cohort study.

ABSTRACT:

Background

Mycoplasma genitalium has a tendency to develop macrolide and quinolone resistance.

Objectives

We investigated the microbiological cure rate of a 7 day course of sitafloxacin for the treatment of rectal and urogenital infections in MSM.

Patients and methods

This open-label, prospective cohort study was conducted at the National Center for Global Health and Medicine, Tokyo, Japan from January 2019 to August 2022. Patients with M. genitalium urogenital or rectal infections were included. The patients were treated with sitafloxacin 200 mg daily for 7 days. M. genitalium isolates were tested for parC, gyrA and 23S rRNA resistance-associated mutations.

Results

In total, 180 patients (median age, 35 years) were included in this study, of whom 77.0% (97/126) harboured parC mutations, including 71.4% (90/126) with G248T(S83I) in parC, and 22.5% (27/120) harboured gyrA mutations. The median time to test of cure was 21 days. The overall microbiological cure rate was 87.8%. The cure rate was 100% for microbes harbouring parC and gyrA WTs, 92.9% for microbes harbouring parC G248T(S83I) and gyrA WT, and 41.7% for microbes harbouring parC G248T(S83I) and gyrA with mutations. The cure rate did not differ significantly between urogenital and rectal infection (P = 0.359).

Conclusions

Sitafloxacin monotherapy was highly effective against infection caused by M. genitalium, except strains with combined parC and gyrA mutations. Sitafloxacin monotherapy can be used as a first-line treatment for M. genitalium infections in settings with a high prevalence of parC mutations and a low prevalence of gyrA mutations.

SUBMITTER: Ando N

PROVIDER: S-EPMC10393875 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of sitafloxacin monotherapy for quinolone-resistant rectal and urogenital Mycoplasma genitalium infections: a prospective cohort study.

Ando Naokatsu N Mizushima Daisuke D Takano Misao M Mitobe Morika M Kobayashi Kai K Kubota Hiroaki H Miyake Hirofumi H Suzuki Jun J Sadamasu Kenji K Aoki Takahiro T Watanabe Koji K Uemura Haruka H Yanagawa Yasuaki Y Gatanaga Hiroyuki H Oka Shinichi S

The Journal of antimicrobial chemotherapy 20230801 8

<h4>Background</h4>Mycoplasma genitalium has a tendency to develop macrolide and quinolone resistance.<h4>Objectives</h4>We investigated the microbiological cure rate of a 7 day course of sitafloxacin for the treatment of rectal and urogenital infections in MSM.<h4>Patients and methods</h4>This open-label, prospective cohort study was conducted at the National Center for Global Health and Medicine, Tokyo, Japan from January 2019 to August 2022. Patients with M. genitalium urogenital or rectal in ...[more]

PMID: 37376970

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Project description:Abstract Background M. genitalium (M. gen) is an under-recognized sexually transmitted bacterial pathogen that causes 15-25% of nongonococcal urethritis (NGU) in men. Asymptomatic M. gen may serve as a reservoir, lead to transmission to sexual contacts, and drive the development of drug resistance. M. gen may be associated with an increased risk of HIV acquisition, as seen in some studies. Data are limited on M. gen prevalence among U.S. men who have sex with men (MSM) living with HIV or HIV-uninfected and on pre-exposure prophylaxis (PrEP). Methods We analyzed baseline prevalence of urogenital and rectal M. gen using the Aptima Mycoplasma genitalium nucleic acid amplification test in participants enrolled in DoxyPEP, an ongoing randomized, open label trial of the effectiveness of doxycycline post-exposure prophylaxis (PEP) on incidence of gonorrhea, chlamydia, and early syphilis among MSM and transgender women living with HIV or on PrEP in San Francisco and Seattle (NCT03980223). Participants completing at least one follow up visit were also assessed for M. gen persistence, clearance, and incidence. Testing was at regular intervals and not symptom driven. Results This analysis included 122 men; 34% with HIV and 66% on PrEP. In the prior 12 months, 18.9% had a diagnosis of syphilis, 58.2% chlamydia, and 63.9% gonorrhea. At baseline, M. gen was present in at least one site in 24%; 9% in the urine and 16% in the rectum, with 1 testing positive at both sites. M. gen presence was not associated with age, ethnicity, race, HIV status, number of partners in the past 3 months, or bacterial STI in the past 3 months. 65 participants had follow up tests a median of 9.1 months after baseline (IQR 7.8-9.8); among 7 participants with urogenital M. gen at baseline, M. gen cleared in 6 and persisted in 1. Among 11 participants with rectal M. gen at baseline, M. gen cleared in 4 cleared and persisted in 7. At follow up, M. gen was detected in 2 urine and 9 rectal specimens in those previously negative at these sites. Figure 1. Baseline prevalence of urogenital and rectal M. genitalium in MSM at high risk for STIs enrolled in DoxyPEP Figure 2. Detection of urogenital and rectal M. genitalium among participants with baseline and follow up testing Conclusion In this cohort of MSM with a recent diagnosis of a bacterial STI, routine testing identified urogenital or rectal M. gen in 24% of participants at baseline and 31% at either baseline or follow-up. The association of persistent M. gen with the risk for subsequent symptomatic infection and drug resistance merits further investigation. Disclosures Emma D. Bainbridge, MD, MPH, Hologic (Grant/Research Support) Olusegun O. Soge, PhD, Hologic Inc. (Grant/Research Support)SpeeDx Inc. (Grant/Research Support) Annie Luetkemeyer, MD, Cepheid (Grant/Research Support)Hologic (Grant/Research Support)Mayne Pharma (Grant/Research Support)

Project description:BackgroundThis study evaluated the distribution of macrolide-resistant Mycoplasma genitalium in multiple urogenital specimens collected from women enrolled in a prospective multicenter US clinical study.MethodsFour female urogenital specimens (vaginal swab, urine, endocervical swab, ectocervical brush/spatula) collected from each subject were tested using a transcription-mediated amplification (TMA) assay for M. genitalium. TMA-positive specimens were evaluated by reverse transcription-polymerase chain reaction and bidirectional Sanger sequencing of M. genitalium 23S rRNA to identify the presence of macrolide-resistance-mediating mutations (MRMs) at base positions 2058/2059.ResultsOf 140 women with ≥1 TMA-positive specimens, 128 (91.4%) yielded M. genitalium 23S rRNA sequence. MRMs were found in 52% of vaginal specimens, 46.3% of urine specimens, 37.8% of endocervical specimens, and 46% of ectocervical specimens. There were 44 unique specimen type/sequence phenotype combinations of M. genitalium infection. Most (81; 63.3%) women had single specimen-sequence phenotype (macrolide-susceptible, MRM, or both) infections, while 24 (18.8%) women had multiple specimen-sequence phenotype concordant infections, and 23 (17.9%) women had multiple specimen-sequence phenotype discordant infections. The sensitivity for any single specimen type to detect overall urogenital tract macrolide-resistant M. genitalium infection status was 96.3% for vaginal swab samples, 82.6% for urine samples, 70.8% for endocervical swab samples, and 82.1% for ectocervical brush/spatula liquid Pap samples.ConclusionsThe distribution of M. genitalium infections in female urogenital tract specimens is highly complex, with multiple phenotypic combinations of the organism infecting a significant proportion of women at different anatomic specimen collection sites. Vaginal swab sampling yielded the highest sensitivity for identifying women with macrolide-resistant M. genitalium urogenital tract infections.

Project description:BackgroundMycoplasma genitalium (MG) causes urethritis, cervicitis and pelvic inflammatory disease. The MG treatment failure rate using 1 g azithromycin at an Australian Sexual Health clinic in 2007-9 was 31% (95%CI 23-40%). We developed a rapid high resolution melt analysis (HRMA) assay targeting resistance mutations in the MG 23S rRNA gene, and validated it against DNA sequencing by examining pre- and post-treatment archived samples from MG-infected patients.Methodology/principal findingsAvailable MG-positive pre-treatment (n = 82) and post-treatment samples from individuals with clinical treatment failure (n = 20) were screened for 23S rRNA gene mutations. Sixteen (20%) pre-treatment samples possessed resistance mutations (A2058G, A2059G, A2059C), which were significantly more common in patients with symptomatic azithromycin-treatment failure (12/26; 44%) than in those clinically cured (4/56; 7%), p<0.001. All 20 patients experiencing azithromycin-failure had detectable mutations in their post-treatment samples. In 9 of these cases, the same mutational types were present in both pre- and post-treatment samples indicating transmitted resistance, whilst in 11 of these cases (55%), mutations were absent in pre-treatment samples indicating likely selection of resistant isolates have occurred. HRMA was able to detect all mutational changes determined in this study by DNA sequencing. An additional HRMA assay incorporating an unlabelled probe was also developed to detect type 4 single-nucleotide polymorphisms found in other populations, with a slightly lower sensitivity of 90%.Conclusions/significanceTreatment failure is associated with the detection of macrolide resistance mutations, which appear to be almost equally due to selection of resistant isolates following exposure to 1 g azithromycin and pre-existing transmitted resistance. The application of a rapid molecular assay to detect resistance at the time of initial detection of infection allows clinicians to shorten the time to initiate effective second line treatment. This has the potential to reduce transmission of resistant strains and to avoid sequelae associated with persistent untreated infection.

Dataset Information

Effectiveness of sitafloxacin monotherapy for quinolone-resistant rectal and urogenital Mycoplasma genitalium infections: a prospective cohort study.

Background

Objectives

Patients and methods

Results

Conclusions

Publications

Effectiveness of sitafloxacin monotherapy for quinolone-resistant rectal and urogenital Mycoplasma genitalium infections: a prospective cohort study.

Similar Datasets

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