Clinical utility of oral Nemonoxacin 500 mg once daily for the treatment of acute lower urinary tract infections: a prospective open-label, multicenter study
Abstract Background Urinary tract infection (UTI) is one of the most common infectious diseases requiring convenient and appropriate treatment. Nemonoxacin is active against the common pathogens of UTIs. However, more clinical data are required to further support the utility of 500 mg nemonoxacin on...
Saved in:
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2025-04-01
|
| Series: | BMC Infectious Diseases |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12879-025-10915-5 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849726752628146176 |
|---|---|
| author | Zhen Du Bo Zheng Shan Chen Liang Cui Huilin Wu Zhan Gao Jin Yang Gang Cui Jiajing Wang Tiehuan Shu Ninghan Feng Ludong Qiao |
| author_facet | Zhen Du Bo Zheng Shan Chen Liang Cui Huilin Wu Zhan Gao Jin Yang Gang Cui Jiajing Wang Tiehuan Shu Ninghan Feng Ludong Qiao |
| author_sort | Zhen Du |
| collection | DOAJ |
| description | Abstract Background Urinary tract infection (UTI) is one of the most common infectious diseases requiring convenient and appropriate treatment. Nemonoxacin is active against the common pathogens of UTIs. However, more clinical data are required to further support the utility of 500 mg nemonoxacin once daily in treatment of acute lower UTI. Methods We conducted a prospective, single-arm, open-label, multicenter clinical trial in outpatients with acute lower UTI, including uncomplicated UTI (uUTI), recurrent UTI (rUTI), and complicated UTI (cUTI). The patients were prospectively enrolled to take 500 mg nemonoxacin capsules once daily for 3 days (uUTI and rUTI) or 14 days (cUTI). The baseline data, clinical symptoms, laboratory and microbiological tests were analyzed to evaluate the efficacy and safety of nemonoxacin. The clinical and microbiological efficacy were evaluated using the modified intent-to-treat (mITT) set and microbiologically modified intent-to-treat (m-mITT) set, respectively. The comprehensive efficacy and safety were assessed using microbiologically evaluable (ME) set and safety set (SS), respectively. Results A total of 404 patients were enrolled. Majority (90.1%) of the patients were females. More than half (66.3%) of the patients were 20 to 40 years of age, and 19.1% were elderly patients (≥ 60 years). Most (83.2%) of the patients reported two or more urinary tract symptoms. The overall clinical efficacy rate of nemonoxacin was 83.9% (292/348) in mITT set, specifically, 83.9% (186/224) in uUTI, 84.4% (81/96) in rUTI and 89.3% (25/28) in cUTI. The overall microbiological efficacy rate was 76.8% (119/155) in m-mITT set. The overall comprehensive efficacy rate was 73.4% (102/139) in ME set. The incidence of clinical adverse reactions was 7.2% (29/404) in the safety set. Most of the adverse events were mild and transient, including pruritus, nausea, dizziness, and headache. No drug-related serious adverse events were observed. Conclusions Nemonoxacin capsules 500 mg once daily is effective, safe, and well-tolerated for treatment of mild-to-moderate acute lower UTIs in adult outpatients. Trial registration Chinese Clinical Trial Registry (ChiCTR2100046585). Registered on May 22, 2021. |
| format | Article |
| id | doaj-art-3fb8cb02dadb4b37a391b1293e08d22e |
| institution | DOAJ |
| issn | 1471-2334 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj-art-3fb8cb02dadb4b37a391b1293e08d22e2025-08-20T03:10:05ZengBMCBMC Infectious Diseases1471-23342025-04-012511810.1186/s12879-025-10915-5Clinical utility of oral Nemonoxacin 500 mg once daily for the treatment of acute lower urinary tract infections: a prospective open-label, multicenter studyZhen Du0Bo Zheng1Shan Chen2Liang Cui3Huilin Wu4Zhan Gao5Jin Yang6Gang Cui7Jiajing Wang8Tiehuan Shu9Ninghan Feng10Ludong Qiao11Department of Urology, Beijing Tongren Hospital, Capital Medical UniversityInstitute of Clinical Pharmacology, Peking University First Hospital, Peking UniversityDepartment of Urology, Beijing Tongren Hospital, Capital Medical UniversityDepartment of Urology, Civil Aviation General HospitalDepartment of Urology, Jinhua People’s HospitalDepartment of Urology, Xiyuan Hospital, China Academy of Chinese Medical SciencesDepartment of Urology, Affiliated Hospital of Chengdu UniversityDepartment of Urology, Beijing Daxing District People’s Hospital, Capital Medical UniversityDepartment of Urology, Beijing Chuiyangliu HospitalDepartment of Urology, Hunan University of Medicine General HospitalDepartment of Urology, Wuxi Second People’s HospitalDepartment of Urology, Beijing Tongren Hospital, Capital Medical UniversityAbstract Background Urinary tract infection (UTI) is one of the most common infectious diseases requiring convenient and appropriate treatment. Nemonoxacin is active against the common pathogens of UTIs. However, more clinical data are required to further support the utility of 500 mg nemonoxacin once daily in treatment of acute lower UTI. Methods We conducted a prospective, single-arm, open-label, multicenter clinical trial in outpatients with acute lower UTI, including uncomplicated UTI (uUTI), recurrent UTI (rUTI), and complicated UTI (cUTI). The patients were prospectively enrolled to take 500 mg nemonoxacin capsules once daily for 3 days (uUTI and rUTI) or 14 days (cUTI). The baseline data, clinical symptoms, laboratory and microbiological tests were analyzed to evaluate the efficacy and safety of nemonoxacin. The clinical and microbiological efficacy were evaluated using the modified intent-to-treat (mITT) set and microbiologically modified intent-to-treat (m-mITT) set, respectively. The comprehensive efficacy and safety were assessed using microbiologically evaluable (ME) set and safety set (SS), respectively. Results A total of 404 patients were enrolled. Majority (90.1%) of the patients were females. More than half (66.3%) of the patients were 20 to 40 years of age, and 19.1% were elderly patients (≥ 60 years). Most (83.2%) of the patients reported two or more urinary tract symptoms. The overall clinical efficacy rate of nemonoxacin was 83.9% (292/348) in mITT set, specifically, 83.9% (186/224) in uUTI, 84.4% (81/96) in rUTI and 89.3% (25/28) in cUTI. The overall microbiological efficacy rate was 76.8% (119/155) in m-mITT set. The overall comprehensive efficacy rate was 73.4% (102/139) in ME set. The incidence of clinical adverse reactions was 7.2% (29/404) in the safety set. Most of the adverse events were mild and transient, including pruritus, nausea, dizziness, and headache. No drug-related serious adverse events were observed. Conclusions Nemonoxacin capsules 500 mg once daily is effective, safe, and well-tolerated for treatment of mild-to-moderate acute lower UTIs in adult outpatients. Trial registration Chinese Clinical Trial Registry (ChiCTR2100046585). Registered on May 22, 2021.https://doi.org/10.1186/s12879-025-10915-5NemonoxacinOral administrationAcute lower urinary tract infectionClinical efficacyProspective clinical trial |
| spellingShingle | Zhen Du Bo Zheng Shan Chen Liang Cui Huilin Wu Zhan Gao Jin Yang Gang Cui Jiajing Wang Tiehuan Shu Ninghan Feng Ludong Qiao Clinical utility of oral Nemonoxacin 500 mg once daily for the treatment of acute lower urinary tract infections: a prospective open-label, multicenter study BMC Infectious Diseases Nemonoxacin Oral administration Acute lower urinary tract infection Clinical efficacy Prospective clinical trial |
| title | Clinical utility of oral Nemonoxacin 500 mg once daily for the treatment of acute lower urinary tract infections: a prospective open-label, multicenter study |
| title_full | Clinical utility of oral Nemonoxacin 500 mg once daily for the treatment of acute lower urinary tract infections: a prospective open-label, multicenter study |
| title_fullStr | Clinical utility of oral Nemonoxacin 500 mg once daily for the treatment of acute lower urinary tract infections: a prospective open-label, multicenter study |
| title_full_unstemmed | Clinical utility of oral Nemonoxacin 500 mg once daily for the treatment of acute lower urinary tract infections: a prospective open-label, multicenter study |
| title_short | Clinical utility of oral Nemonoxacin 500 mg once daily for the treatment of acute lower urinary tract infections: a prospective open-label, multicenter study |
| title_sort | clinical utility of oral nemonoxacin 500 mg once daily for the treatment of acute lower urinary tract infections a prospective open label multicenter study |
| topic | Nemonoxacin Oral administration Acute lower urinary tract infection Clinical efficacy Prospective clinical trial |
| url | https://doi.org/10.1186/s12879-025-10915-5 |
| work_keys_str_mv | AT zhendu clinicalutilityoforalnemonoxacin500mgoncedailyforthetreatmentofacutelowerurinarytractinfectionsaprospectiveopenlabelmulticenterstudy AT bozheng clinicalutilityoforalnemonoxacin500mgoncedailyforthetreatmentofacutelowerurinarytractinfectionsaprospectiveopenlabelmulticenterstudy AT shanchen clinicalutilityoforalnemonoxacin500mgoncedailyforthetreatmentofacutelowerurinarytractinfectionsaprospectiveopenlabelmulticenterstudy AT liangcui clinicalutilityoforalnemonoxacin500mgoncedailyforthetreatmentofacutelowerurinarytractinfectionsaprospectiveopenlabelmulticenterstudy AT huilinwu clinicalutilityoforalnemonoxacin500mgoncedailyforthetreatmentofacutelowerurinarytractinfectionsaprospectiveopenlabelmulticenterstudy AT zhangao clinicalutilityoforalnemonoxacin500mgoncedailyforthetreatmentofacutelowerurinarytractinfectionsaprospectiveopenlabelmulticenterstudy AT jinyang clinicalutilityoforalnemonoxacin500mgoncedailyforthetreatmentofacutelowerurinarytractinfectionsaprospectiveopenlabelmulticenterstudy AT gangcui clinicalutilityoforalnemonoxacin500mgoncedailyforthetreatmentofacutelowerurinarytractinfectionsaprospectiveopenlabelmulticenterstudy AT jiajingwang clinicalutilityoforalnemonoxacin500mgoncedailyforthetreatmentofacutelowerurinarytractinfectionsaprospectiveopenlabelmulticenterstudy AT tiehuanshu clinicalutilityoforalnemonoxacin500mgoncedailyforthetreatmentofacutelowerurinarytractinfectionsaprospectiveopenlabelmulticenterstudy AT ninghanfeng clinicalutilityoforalnemonoxacin500mgoncedailyforthetreatmentofacutelowerurinarytractinfectionsaprospectiveopenlabelmulticenterstudy AT ludongqiao clinicalutilityoforalnemonoxacin500mgoncedailyforthetreatmentofacutelowerurinarytractinfectionsaprospectiveopenlabelmulticenterstudy |