Evaluation of three-dose fosfomycin tromethamine in the treatment of patients with urinary tract infections: an uncontrolled, open-label, multicentre study
Objective To evaluate the clinical and microbiological efficacy and safety of three doses of 3 g fosfomycin tromethamine administered orally to treat lower urinary tract infections.Design and participants This prospective, uncontrolled, open-label study was conducted in 12 medical centres in China,...
Saved in:
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2013-12-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/3/12/e004157.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1823864509964484608 |
|---|---|
| author | Shan Chen Yong Yang Bo Yang Ming Chen Kai Zhang Yi Wang Lu-Dong Qiao Bo Zheng Hong-Feng Guo Yuan-Jie Niu Ben-Kang Shi Wei-Min Yang Xiao-Kun Zhao Xiao-Feng Gao |
| author_facet | Shan Chen Yong Yang Bo Yang Ming Chen Kai Zhang Yi Wang Lu-Dong Qiao Bo Zheng Hong-Feng Guo Yuan-Jie Niu Ben-Kang Shi Wei-Min Yang Xiao-Kun Zhao Xiao-Feng Gao |
| author_sort | Shan Chen |
| collection | DOAJ |
| description | Objective To evaluate the clinical and microbiological efficacy and safety of three doses of 3 g fosfomycin tromethamine administered orally to treat lower urinary tract infections.Design and participants This prospective, uncontrolled, open-label study was conducted in 12 medical centres in China, between January and December 2011. According to the diagnosis criteria of Chinese Guidelines on Urological Infections, patients (18–70 years) with acute uncomplicated cystitis, recurrent lower urinary tract infection or complicated lower urinary tract infection received three doses of 3 g fosfomycin tromethamine orally, at days 1, 3 and 5.Primary and secondary outcome measures Efficacy endpoints (clinical efficacy, microbiological efficacy and overall efficacy) were evaluated on day 15. Clinical symptoms, physical signs, urinalysis, liver and kidney function, patient records and evaluation of adverse events (AEs) and serious AEs up to day 15 were evaluated for analysis of safety.Results 361 patients were included in the full analysis set, 356 in the safety analysis set and 335 in the per-protocol set (PPS). In the PPS, the clinical efficacy rates at day 15 for acute uncomplicated cystitis, recurrent lower urinary tract infection and complicated lower urinary tract infection were 94.71% (179/189), 77.22% (61/79) and 62.69% (42/67), respectively. The microbiological efficacy rates (day 15) were 97.65% (83/85), 94.44% (34/36) and 83.87% (26/31), respectively. The overall efficacy rates (day 15) were 95.29% (81/85), 77.78% (28/36) and 64.52% (20/31), respectively. 20/356 (5.6%) patients reported drug-related AEs, the most common being diarrhoea. No serious drug-related AEs were reported.Conclusions This fosfomycin tromethamine dosing regimen showed clinical and microbiological efficacy with some AEs and good tolerability in patients with acute uncomplicated cystitis, recurrent lower urinary tract infection and complicated lower urinary tract infection. |
| format | Article |
| id | doaj-art-93a77ea0e14c4d4592b077a56336184f |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2013-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-93a77ea0e14c4d4592b077a56336184f2025-02-09T02:55:09ZengBMJ Publishing GroupBMJ Open2044-60552013-12-0131210.1136/bmjopen-2013-004157Evaluation of three-dose fosfomycin tromethamine in the treatment of patients with urinary tract infections: an uncontrolled, open-label, multicentre studyShan Chen0Yong Yang1Bo Yang2Ming Chen3Kai Zhang4Yi Wang5Lu-Dong Qiao6Bo Zheng7Hong-Feng Guo8Yuan-Jie Niu9Ben-Kang Shi10Wei-Min Yang11Xiao-Kun Zhao12Xiao-Feng Gao131 Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China2 Shantou University Medical College, Shantou, China3 Department of Neurology, Beijing Jiangong Hospital, Beijing, China1 Department of Dermatology, The First Affiliated Hospital of Jinan University and Jinan University Institute of Dermatology, Guangzhou, China1Picture Health, Cleveland, OH, USADepartment of Urology, First Affiliated Hospital of China Medical University, Shenyang, People`s Republic of ChinaDepartment of Urology, Beijing Tongren Hospital Capital Medical University, Beijing, People`s Republic of ChinaDepartment of Epidemiology, Fudan University School of Public Health, Shanghai, ChinaDepartment of Urology, Peking University Shougang Hospital (Wu Jieping Urology Center), Beijing, People`s Republic of ChinaDepartment of Urology, Second Affiliated Hospital of Tianjin Medical University, Tianjin, People`s Republic of ChinaDepartment of Urology, Qilu Hospital of Shandong University, Jinan, People`s Republic of ChinaDepartment of Urology, Wuhan Hubei Tongji Hospital, Wuhan, People`s Republic of ChinaDepartment of Urology, Hunan Province Xiangya Second Hospital, Changsha, People`s Republic of ChinaDepartment of Urology, Shanghai Changhai Hospital, Shanghai, People`s Republic of ChinaObjective To evaluate the clinical and microbiological efficacy and safety of three doses of 3 g fosfomycin tromethamine administered orally to treat lower urinary tract infections.Design and participants This prospective, uncontrolled, open-label study was conducted in 12 medical centres in China, between January and December 2011. According to the diagnosis criteria of Chinese Guidelines on Urological Infections, patients (18–70 years) with acute uncomplicated cystitis, recurrent lower urinary tract infection or complicated lower urinary tract infection received three doses of 3 g fosfomycin tromethamine orally, at days 1, 3 and 5.Primary and secondary outcome measures Efficacy endpoints (clinical efficacy, microbiological efficacy and overall efficacy) were evaluated on day 15. Clinical symptoms, physical signs, urinalysis, liver and kidney function, patient records and evaluation of adverse events (AEs) and serious AEs up to day 15 were evaluated for analysis of safety.Results 361 patients were included in the full analysis set, 356 in the safety analysis set and 335 in the per-protocol set (PPS). In the PPS, the clinical efficacy rates at day 15 for acute uncomplicated cystitis, recurrent lower urinary tract infection and complicated lower urinary tract infection were 94.71% (179/189), 77.22% (61/79) and 62.69% (42/67), respectively. The microbiological efficacy rates (day 15) were 97.65% (83/85), 94.44% (34/36) and 83.87% (26/31), respectively. The overall efficacy rates (day 15) were 95.29% (81/85), 77.78% (28/36) and 64.52% (20/31), respectively. 20/356 (5.6%) patients reported drug-related AEs, the most common being diarrhoea. No serious drug-related AEs were reported.Conclusions This fosfomycin tromethamine dosing regimen showed clinical and microbiological efficacy with some AEs and good tolerability in patients with acute uncomplicated cystitis, recurrent lower urinary tract infection and complicated lower urinary tract infection.https://bmjopen.bmj.com/content/3/12/e004157.full |
| spellingShingle | Shan Chen Yong Yang Bo Yang Ming Chen Kai Zhang Yi Wang Lu-Dong Qiao Bo Zheng Hong-Feng Guo Yuan-Jie Niu Ben-Kang Shi Wei-Min Yang Xiao-Kun Zhao Xiao-Feng Gao Evaluation of three-dose fosfomycin tromethamine in the treatment of patients with urinary tract infections: an uncontrolled, open-label, multicentre study BMJ Open |
| title | Evaluation of three-dose fosfomycin tromethamine in the treatment of patients with urinary tract infections: an uncontrolled, open-label, multicentre study |
| title_full | Evaluation of three-dose fosfomycin tromethamine in the treatment of patients with urinary tract infections: an uncontrolled, open-label, multicentre study |
| title_fullStr | Evaluation of three-dose fosfomycin tromethamine in the treatment of patients with urinary tract infections: an uncontrolled, open-label, multicentre study |
| title_full_unstemmed | Evaluation of three-dose fosfomycin tromethamine in the treatment of patients with urinary tract infections: an uncontrolled, open-label, multicentre study |
| title_short | Evaluation of three-dose fosfomycin tromethamine in the treatment of patients with urinary tract infections: an uncontrolled, open-label, multicentre study |
| title_sort | evaluation of three dose fosfomycin tromethamine in the treatment of patients with urinary tract infections an uncontrolled open label multicentre study |
| url | https://bmjopen.bmj.com/content/3/12/e004157.full |
| work_keys_str_mv | AT shanchen evaluationofthreedosefosfomycintromethamineinthetreatmentofpatientswithurinarytractinfectionsanuncontrolledopenlabelmulticentrestudy AT yongyang evaluationofthreedosefosfomycintromethamineinthetreatmentofpatientswithurinarytractinfectionsanuncontrolledopenlabelmulticentrestudy AT boyang evaluationofthreedosefosfomycintromethamineinthetreatmentofpatientswithurinarytractinfectionsanuncontrolledopenlabelmulticentrestudy AT mingchen evaluationofthreedosefosfomycintromethamineinthetreatmentofpatientswithurinarytractinfectionsanuncontrolledopenlabelmulticentrestudy AT kaizhang evaluationofthreedosefosfomycintromethamineinthetreatmentofpatientswithurinarytractinfectionsanuncontrolledopenlabelmulticentrestudy AT yiwang evaluationofthreedosefosfomycintromethamineinthetreatmentofpatientswithurinarytractinfectionsanuncontrolledopenlabelmulticentrestudy AT ludongqiao evaluationofthreedosefosfomycintromethamineinthetreatmentofpatientswithurinarytractinfectionsanuncontrolledopenlabelmulticentrestudy AT bozheng evaluationofthreedosefosfomycintromethamineinthetreatmentofpatientswithurinarytractinfectionsanuncontrolledopenlabelmulticentrestudy AT hongfengguo evaluationofthreedosefosfomycintromethamineinthetreatmentofpatientswithurinarytractinfectionsanuncontrolledopenlabelmulticentrestudy AT yuanjieniu evaluationofthreedosefosfomycintromethamineinthetreatmentofpatientswithurinarytractinfectionsanuncontrolledopenlabelmulticentrestudy AT benkangshi evaluationofthreedosefosfomycintromethamineinthetreatmentofpatientswithurinarytractinfectionsanuncontrolledopenlabelmulticentrestudy AT weiminyang evaluationofthreedosefosfomycintromethamineinthetreatmentofpatientswithurinarytractinfectionsanuncontrolledopenlabelmulticentrestudy AT xiaokunzhao evaluationofthreedosefosfomycintromethamineinthetreatmentofpatientswithurinarytractinfectionsanuncontrolledopenlabelmulticentrestudy AT xiaofenggao evaluationofthreedosefosfomycintromethamineinthetreatmentofpatientswithurinarytractinfectionsanuncontrolledopenlabelmulticentrestudy |