Clinical effectiveness and bacteriological eradication of three different Short-COurse antibiotic regimens and single-dose fosfomycin for uncomplicated lower Urinary Tract infections in adult women (SCOUT study) : study protocol for a randomised clinical trial
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
INTRODUCTION: Uncomplicated lower urinary tract infections (uLUTI) are a common problem in primary care. Current local guidelines recommend the use of a single 3 g dose of fosfomycin. However, most general practitioners (GP) prefer short-course therapies to single-dose therapy. No study has compared head-to-head short-course antimicrobial agents for uLUTIs. Therefore, the aim of this randomised clinical trial is to compare three different short-course antibiotic therapies with a single-dose of fosfomycin for these infections.
METHODS AND ANALYSIS: This will be a pragmatic, multicentre, parallel group, open trial. Women aged 18 or older and with symptoms of uLUTI and a positive urine dipstick analysis will be randomised to one of the following four groups: a single dose of 3 g of fosfomycin, 2 days of 3 g of fosfomycin o.d., 3 days of pivmecillinam 400 mg three times per day (t.i.d) or 5 days of nitrofurantoin 100 mg t.i.d. A total sample of 1120 patients was calculated. The primary endpoint is clinical effectiveness at day 7, defined as cure of symptoms reported by the patients in a diary including four symptoms: dysuria, urgency, frequency and suprapubic pain, which will be scored on a 4-point severity scale (not present/mild/moderate/severe). Follow-up visits are scheduled at days 7 (phone call), 14 and 28 for assessing evolution. Urine samples will be collected in the three on-site visits and urine cultures performed. If positive, antibiograms for the three antibiotics studied will be performed. Bacterial eradication will be measured at days 14 and 28.
ETHICS AND DISSEMINATION: The study was approved by the Ethical Board of IDIAP Jordi Gol (reference number: 21/173-AC) and Spanish Agency of Medicines and Medical Devices. The findings of this trial will be disseminated through research conferences and peer-review journals.
TRIAL REGISTRATION NUMBER: NCT04959331; EudraCT Number: 2021-001332-26.
TIME SCHEDULE: January 2022 to April 2023.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:11 |
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| Enthalten in: |
BMJ open - 11(2021), 11 vom: 25. Nov., Seite e055898 |
| Sprache: |
Englisch |
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| Links: |
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| Anmerkungen: |
Date Completed 06.12.2021 Date Revised 31.05.2022 published: Electronic ClinicalTrials.gov: NCT04959331 Citation Status MEDLINE |
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| doi: |
10.1136/bmjopen-2021-055898 |
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| 100 | 1 | |a Garcia-Sangenís, Ana |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Clinical effectiveness and bacteriological eradication of three different Short-COurse antibiotic regimens and single-dose fosfomycin for uncomplicated lower Urinary Tract infections in adult women (SCOUT study) |b study protocol for a randomised clinical trial |
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| 500 | |a Date Completed 06.12.2021 | ||
| 500 | |a Date Revised 31.05.2022 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04959331 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a INTRODUCTION: Uncomplicated lower urinary tract infections (uLUTI) are a common problem in primary care. Current local guidelines recommend the use of a single 3 g dose of fosfomycin. However, most general practitioners (GP) prefer short-course therapies to single-dose therapy. No study has compared head-to-head short-course antimicrobial agents for uLUTIs. Therefore, the aim of this randomised clinical trial is to compare three different short-course antibiotic therapies with a single-dose of fosfomycin for these infections | ||
| 520 | |a METHODS AND ANALYSIS: This will be a pragmatic, multicentre, parallel group, open trial. Women aged 18 or older and with symptoms of uLUTI and a positive urine dipstick analysis will be randomised to one of the following four groups: a single dose of 3 g of fosfomycin, 2 days of 3 g of fosfomycin o.d., 3 days of pivmecillinam 400 mg three times per day (t.i.d) or 5 days of nitrofurantoin 100 mg t.i.d. A total sample of 1120 patients was calculated. The primary endpoint is clinical effectiveness at day 7, defined as cure of symptoms reported by the patients in a diary including four symptoms: dysuria, urgency, frequency and suprapubic pain, which will be scored on a 4-point severity scale (not present/mild/moderate/severe). Follow-up visits are scheduled at days 7 (phone call), 14 and 28 for assessing evolution. Urine samples will be collected in the three on-site visits and urine cultures performed. If positive, antibiograms for the three antibiotics studied will be performed. Bacterial eradication will be measured at days 14 and 28 | ||
| 520 | |a ETHICS AND DISSEMINATION: The study was approved by the Ethical Board of IDIAP Jordi Gol (reference number: 21/173-AC) and Spanish Agency of Medicines and Medical Devices. The findings of this trial will be disseminated through research conferences and peer-review journals | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT04959331; EudraCT Number: 2021-001332-26 | ||
| 520 | |a TIME SCHEDULE: January 2022 to April 2023 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a microbiology | |
| 650 | 4 | |a primary care | |
| 650 | 4 | |a public health | |
| 650 | 4 | |a urinary tract infections | |
| 650 | 7 | |a Anti-Bacterial Agents |2 NLM | |
| 650 | 7 | |a Fosfomycin |2 NLM | |
| 650 | 7 | |a 2N81MY12TE |2 NLM | |
| 650 | 7 | |a Nitrofurantoin |2 NLM | |
| 650 | 7 | |a 927AH8112L |2 NLM | |
| 700 | 1 | |a Morros, Rosa |e verfasserin |4 aut | |
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| 700 | 1 | |a Leiva, Alfonso |e verfasserin |4 aut | |
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| 700 | 1 | |a Marín-Cañada, Jaime |e verfasserin |4 aut | |
| 700 | 1 | |a Molero, José M |e verfasserin |4 aut | |
| 700 | 1 | |a Moragas, Ana |e verfasserin |4 aut | |
| 700 | 1 | |a Troncoso, Amelia |e verfasserin |4 aut | |
| 700 | 1 | |a Monfà, Ramon |e verfasserin |4 aut | |
| 700 | 1 | |a Llor, Carl |e verfasserin |4 aut | |
| 700 | 0 | |a SCOUT Study Group |e verfasserin |4 aut | |
| 700 | 1 | |a Bolíbar, Bonaventura |e investigator |4 oth | |
| 700 | 1 | |a Ouchi-Vernet, Dan |e investigator |4 oth | |
| 700 | 1 | |a Berenguera, Anna |e investigator |4 oth | |
| 700 | 1 | |a Cots, Josep M |e investigator |4 oth | |
| 700 | 1 | |a Cobo, Sílvia |e investigator |4 oth | |
| 700 | 1 | |a Gómez, Fede |e investigator |4 oth | |
| 700 | 1 | |a Cabello, Ignacio Ricci |e investigator |4 oth | |
| 700 | 1 | |a Vicens-Caldentey, Catalina |e investigator |4 oth | |
| 700 | 1 | |a Ramírez-Manent, José I |e investigator |4 oth | |
| 700 | 1 | |a Soler-Mieras, Aina |e investigator |4 oth | |
| 700 | 1 | |a Quintana-Torres, Lourdes |e investigator |4 oth | |
| 700 | 1 | |a Llobera-Cànaves, Joan |e investigator |4 oth | |
| 700 | 1 | |a Roca-Casas, Antonia |e investigator |4 oth | |
| 700 | 1 | |a Yáñez-Juan, Aina M |e investigator |4 oth | |
| 700 | 1 | |a Alcoceba-Cruixent, Eva |e investigator |4 oth | |
| 700 | 1 | |a Ballester-Camps, Antonio |e investigator |4 oth | |
| 700 | 1 | |a Bulilete, Oana |e investigator |4 oth | |
| 700 | 1 | |a Consuelo Camionero-Soto, M |e investigator |4 oth | |
| 700 | 1 | |a Bordoy, Joan Pou |e investigator |4 oth | |
| 700 | 1 | |a Antonia Sánchez-Calavera, M |e investigator |4 oth | |
| 700 | 1 | |a Royán-Molero, Pilar |e investigator |4 oth | |
| 700 | 1 | |a Shafi-Tabatebaei, Nima Peyman-Fard |e investigator |4 oth | |
| 700 | 1 | |a García-Roy, África |e investigator |4 oth | |
| 700 | 1 | |a Jabal-Calvillo, Raquel |e investigator |4 oth | |
| 700 | 1 | |a Lasilla-Fernández, Lucía |e investigator |4 oth | |
| 700 | 1 | |a Hurtado-Gutiérrez, Andrea |e investigator |4 oth | |
| 700 | 1 | |a Vich-Pérez, Pilar |e investigator |4 oth | |
| 700 | 1 | |a Triano-Sánchez, Rocío C |e investigator |4 oth | |
| 700 | 1 | |a Ávila-Sánchez, José |e investigator |4 oth | |
| 700 | 1 | |a Gómez-García, Manuel |e investigator |4 oth | |
| 700 | 1 | |a Prieto-Checa, Isabel |e investigator |4 oth | |
| 700 | 1 | |a Nogueol-Álvarez, Mar |e investigator |4 oth | |
| 700 | 1 | |a Sánchez-Iñigo, Cristina |e investigator |4 oth | |
| 700 | 1 | |a Garcia Espinosa, Maria Victoria |e investigator |4 oth | |
| 700 | 1 | |a Leandro, Marta Lor |e investigator |4 oth | |
| 700 | 1 | |a González, Lidia Escribano |e investigator |4 oth | |
| 700 | 1 | |a Ortiz, Luís Benito |e investigator |4 oth | |
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