Sitafloxacin- Versus Moxifloxacin-Based Sequential Treatment for Mycoplasma Genitalium Infections: Protocol for a Multicenter, Open-Label Randomized Controlled Trial
BackgroundMycoplasma genitalium is an emerging sexually transmitted pathogen associated with increasing antibiotic resistance. The current treatment guidelines recommend moxifloxacin-sequential therapy for macrolide-resistant Mgenitalium or strains with unknown resistance pro...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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JMIR Publications
2023-11-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2023/1/e52565 |
| _version_ | 1797628018174197760 |
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| author | Naokatsu Ando Daisuke Mizushima Yosuke Shimizu Yukari Uemura Misao Takano Morika Mitobe Kai Kobayashi Hiroaki Kubota Hirofumi Miyake Jun Suzuki Kenji Sadamasu Takato Nakamoto Takahiro Aoki Koji Watanabe Shinichi Oka Hiroyuki Gatanaga |
| author_facet | Naokatsu Ando Daisuke Mizushima Yosuke Shimizu Yukari Uemura Misao Takano Morika Mitobe Kai Kobayashi Hiroaki Kubota Hirofumi Miyake Jun Suzuki Kenji Sadamasu Takato Nakamoto Takahiro Aoki Koji Watanabe Shinichi Oka Hiroyuki Gatanaga |
| author_sort | Naokatsu Ando |
| collection | DOAJ |
| description |
BackgroundMycoplasma genitalium is an emerging sexually transmitted pathogen associated with increasing antibiotic resistance. The current treatment guidelines recommend moxifloxacin-sequential therapy for macrolide-resistant Mgenitalium or strains with unknown resistance profiles. However, it is unclear whether sitafloxacin, a 4th-generation fluoroquinolone antibiotic, is effective against resistant strains.
ObjectiveThis study aims to assess and compare the efficacy and safety of sitafloxacin- and moxifloxacin-based treatment regimens for managing Mgenitalium infections.
MethodsWe will conduct this randomized controlled trial at multiple centers in Japan. Eligible participants include adults aged 18 years or older with a confirmed Mgenitalium infection, as determined through the nucleic acid amplification test. Patients will be randomly assigned using a stratified approach based on the treatment facility and infection site. The interventions comprise oral sitafloxacin (200 mg) daily for 7 days (with optional pretreatment of oral doxycycline, 200 mg, daily for up to 7 days), with a control group receiving oral doxycycline (200 mg) daily for 7 days followed by moxifloxacin (400 mg) daily for another 7 days. The primary outcome is the treatment success rate with a superiority margin of 10%, as confirmed through the nucleic acid amplification test. Secondary outcomes encompass changes in the bacterial load at the urogenital or rectal sites and the emergence of posttreatment-resistant mutant strains.
ResultsEnrollment commenced in June 2023 and will conclude in December 2024, with findings anticipated by 2025. The expected success rates fall within the range of 80% for sitafloxacin and 42% for moxifloxacin against Mgenitalium carrying the G248T (S83I) mutation, based on previous studies. Accordingly, with a 5% significance level (2-sided) and 80% statistical power, we aim to recruit 50 participants per group, factoring in a 10% expected dropout rate.
ConclusionsThis study will provide valuable insights into the efficacy and safety of sitafloxacin- versus moxifloxacin-based sequential therapy in treating Mgenitalium infections. These findings have the potential to influence clinical guidelines, favoring more effective therapeutic choices. The multicenter approach enhances the robustness of this study. However, a limitation is the potential insufficiency of statistical power to detect posttreatment-resistant mutant strains in each group, rendering posttreatment-resistance mutations a notable concern. In the future, we may need to increase the sample size to enhance power.
Trial RegistrationJapan Registry of Clinical Trials (jRCTs031230111); https://jrct.niph.go.jp/en-latest-detail/jRCTs031230111
International Registered Report Identifier (IRRID)DERR1-10.2196/52565 |
| first_indexed | 2024-03-11T10:32:35Z |
| format | Article |
| id | doaj.art-5eb14bf7df8444d0bc1f8f748691b975 |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-11T10:32:35Z |
| publishDate | 2023-11-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-5eb14bf7df8444d0bc1f8f748691b9752023-11-14T13:46:04ZengJMIR PublicationsJMIR Research Protocols1929-07482023-11-0112e5256510.2196/52565Sitafloxacin- Versus Moxifloxacin-Based Sequential Treatment for Mycoplasma Genitalium Infections: Protocol for a Multicenter, Open-Label Randomized Controlled TrialNaokatsu Andohttps://orcid.org/0000-0002-5520-2780Daisuke Mizushimahttps://orcid.org/0000-0001-8424-4616Yosuke Shimizuhttps://orcid.org/0000-0002-9255-3395Yukari Uemurahttps://orcid.org/0000-0002-3013-7775Misao Takanohttps://orcid.org/0000-0001-5059-110XMorika Mitobehttps://orcid.org/0000-0002-1466-7661Kai Kobayashihttps://orcid.org/0000-0003-4524-284XHiroaki Kubotahttps://orcid.org/0000-0002-6339-8568Hirofumi Miyakehttps://orcid.org/0000-0003-3629-5333Jun Suzukihttps://orcid.org/0009-0006-2322-9176Kenji Sadamasuhttps://orcid.org/0000-0003-0541-706XTakato Nakamotohttps://orcid.org/0000-0002-0547-1026Takahiro Aokihttps://orcid.org/0009-0002-4451-599XKoji Watanabehttps://orcid.org/0000-0002-3190-8439Shinichi Okahttps://orcid.org/0000-0002-9283-2167Hiroyuki Gatanagahttps://orcid.org/0000-0001-9191-9984 BackgroundMycoplasma genitalium is an emerging sexually transmitted pathogen associated with increasing antibiotic resistance. The current treatment guidelines recommend moxifloxacin-sequential therapy for macrolide-resistant Mgenitalium or strains with unknown resistance profiles. However, it is unclear whether sitafloxacin, a 4th-generation fluoroquinolone antibiotic, is effective against resistant strains. ObjectiveThis study aims to assess and compare the efficacy and safety of sitafloxacin- and moxifloxacin-based treatment regimens for managing Mgenitalium infections. MethodsWe will conduct this randomized controlled trial at multiple centers in Japan. Eligible participants include adults aged 18 years or older with a confirmed Mgenitalium infection, as determined through the nucleic acid amplification test. Patients will be randomly assigned using a stratified approach based on the treatment facility and infection site. The interventions comprise oral sitafloxacin (200 mg) daily for 7 days (with optional pretreatment of oral doxycycline, 200 mg, daily for up to 7 days), with a control group receiving oral doxycycline (200 mg) daily for 7 days followed by moxifloxacin (400 mg) daily for another 7 days. The primary outcome is the treatment success rate with a superiority margin of 10%, as confirmed through the nucleic acid amplification test. Secondary outcomes encompass changes in the bacterial load at the urogenital or rectal sites and the emergence of posttreatment-resistant mutant strains. ResultsEnrollment commenced in June 2023 and will conclude in December 2024, with findings anticipated by 2025. The expected success rates fall within the range of 80% for sitafloxacin and 42% for moxifloxacin against Mgenitalium carrying the G248T (S83I) mutation, based on previous studies. Accordingly, with a 5% significance level (2-sided) and 80% statistical power, we aim to recruit 50 participants per group, factoring in a 10% expected dropout rate. ConclusionsThis study will provide valuable insights into the efficacy and safety of sitafloxacin- versus moxifloxacin-based sequential therapy in treating Mgenitalium infections. These findings have the potential to influence clinical guidelines, favoring more effective therapeutic choices. The multicenter approach enhances the robustness of this study. However, a limitation is the potential insufficiency of statistical power to detect posttreatment-resistant mutant strains in each group, rendering posttreatment-resistance mutations a notable concern. In the future, we may need to increase the sample size to enhance power. Trial RegistrationJapan Registry of Clinical Trials (jRCTs031230111); https://jrct.niph.go.jp/en-latest-detail/jRCTs031230111 International Registered Report Identifier (IRRID)DERR1-10.2196/52565https://www.researchprotocols.org/2023/1/e52565 |
| spellingShingle | Naokatsu Ando Daisuke Mizushima Yosuke Shimizu Yukari Uemura Misao Takano Morika Mitobe Kai Kobayashi Hiroaki Kubota Hirofumi Miyake Jun Suzuki Kenji Sadamasu Takato Nakamoto Takahiro Aoki Koji Watanabe Shinichi Oka Hiroyuki Gatanaga Sitafloxacin- Versus Moxifloxacin-Based Sequential Treatment for Mycoplasma Genitalium Infections: Protocol for a Multicenter, Open-Label Randomized Controlled Trial JMIR Research Protocols |
| title | Sitafloxacin- Versus Moxifloxacin-Based Sequential Treatment for Mycoplasma Genitalium Infections: Protocol for a Multicenter, Open-Label Randomized Controlled Trial |
| title_full | Sitafloxacin- Versus Moxifloxacin-Based Sequential Treatment for Mycoplasma Genitalium Infections: Protocol for a Multicenter, Open-Label Randomized Controlled Trial |
| title_fullStr | Sitafloxacin- Versus Moxifloxacin-Based Sequential Treatment for Mycoplasma Genitalium Infections: Protocol for a Multicenter, Open-Label Randomized Controlled Trial |
| title_full_unstemmed | Sitafloxacin- Versus Moxifloxacin-Based Sequential Treatment for Mycoplasma Genitalium Infections: Protocol for a Multicenter, Open-Label Randomized Controlled Trial |
| title_short | Sitafloxacin- Versus Moxifloxacin-Based Sequential Treatment for Mycoplasma Genitalium Infections: Protocol for a Multicenter, Open-Label Randomized Controlled Trial |
| title_sort | sitafloxacin versus moxifloxacin based sequential treatment for mycoplasma genitalium infections protocol for a multicenter open label randomized controlled trial |
| url | https://www.researchprotocols.org/2023/1/e52565 |
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