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Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women. (SCOUT)

Primary Purpose

Urinary Tract Infections

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Fosfomycin Trometamol Salt
Nitrofurantoin
Pivmecillinam
Fosfomycin Trometamol Salt
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infections focused on measuring Urinary Tract Infections, Women, Patient Outcome Assessment, Bacteriological Eradication, Urinalysis, Anti-Bacterial Agents, Antimicrobial Resistance, Short Course, Primary Health Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women of 18 years of age or older, with clinical features of uncomplicated community-acquired lower urinary tract infection including:

  • At least one of four key symptoms of lower urinary tract infection: dysuria, urgency including nycturia, frequency, and suprapubic tenderness that could be attributed to an uncomplicated lower urinary tract infection, and no alternative explanation (i.e. symptoms suggestive of sexually-transmitted infection or vulvovaginitis), and
  • A urine dipstick analysis positive for either nitrites or leukocyte esterase.

Exclusion Criteria:

  • Male sex
  • High suspicion of pyelonephritis (i.e. fever ≥ 37.5°C or flank pain/tenderness)
  • Any condition that may lead or predispose to complicated urinary infection (i.e. indwelling urinary catheter, pregnancy, immunosuppressive therapy, abnormal urinary tracts, recurrent urinary tract infection, severe neurological disease affecting the bladder)
  • Pregnancy or planned pregnancy
  • Symptoms consistent with urinary tract infection in the preceding 4 weeks
  • Patients taking long-term antibiotic prophylaxis
  • Ongoing antibiotic therapy or use of any systemic antibiotic in the previous 7 days
  • Symptoms correlating with differential diagnosis (i.e. vaginal discharge or pain)
  • Hypersensitivity or allergy to β lactams, nitrofurantoin and/or fosfomycin
  • Moderate to severe chronic renal insufficiency
  • Pre-existing polyneuropathy
  • History of lung or liver reaction or peripheral neuropathy after previous use of nitrofurantoin
  • Glucose-6-phosphate dehydrogenase deficiency
  • Porphyria or systemic primary carnitine deficiency or of the type organic aciduria (i.e. methylmalonic aciduria and propionicacidaemia)
  • Esophageal stricture
  • Current intake of allopurinol or probenecid or valproate
  • Currently part of another randomized clinical trial
  • Previous enrolment in the proposed study
  • Patients living in long-term institutions; and/or
  • Difficulty in conducting scheduled follow-up visits

Sites / Locations

  • Arrabal Health CenterRecruiting
  • Parque Goya Health CenterRecruiting
  • Santa Ponça Health CenterRecruiting
  • Escola Graduada Health CenterRecruiting
  • Camp Redó Health CenterRecruiting
  • Son Serra-La Vileta Health CenterRecruiting
  • La Gavarra Health CenterRecruiting
  • Jaume I Health CenterRecruiting
  • Valleaguado Health Center
  • San Fernando Health Center
  • Villarejo de Salvanés Health Center
  • Los Alpes Health Center
  • Aquitania Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Short-course fosfomycin

Short-course nitrofurantoin

Short-course pivmecillinam

Single-dose fosfomycin

Arm Description

3 g of fosfomycin once daily for two days (sachets)

Five-day nitrofurantoin 100 mg t.i.d. (pills)

Three-day pivmecillinam 400 mg. t.i.d. (pills)

Single 3 g dose of fosfomycin (sachet)

Outcomes

Primary Outcome Measures

Clinical effectiveness.
Proportion of patients who report being cured, defined as the resolution of the four symptoms, scoring 0 in the symptom diary.
Bacteriological eradication.
Proportion of patients bacteriologically cured, defined as less than 1,000 cfu/ml.

Secondary Outcome Measures

Duration of symptoms.
Number of days until the last day the patient scores 0 in any of the four symptoms.
Bacteriological eradication.
Proportion of patients bacteriologically cured, defined as less than 1,000 cfu/ml.
Relapse rate.
Proportion of patients presenting a relapse of symptoms within the first four weeks after inclusion in the study and timing of relapse of symptoms and/or bacteriuria.
Reattendance and complication rate.
Proportion of patients re-attending healthcare services and development of complications within the first 4 weeks (i.e. pyelonephritis, urosepsis).
Adverse event rate.
Proportion of patients presenting adverse and serious adverse events.
Change in quality of life.
Change in the quality of life by means of the EQ-5D-5L validated questionnaire (Spanish version).

Full Information

First Posted
July 5, 2021
Last Updated
August 29, 2022
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Balearic Islands Health Service (Ibsalut), Instituto de Investigación Sanitaria Aragón, Gerencia de Atención Primaria, Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT04959331
Brief Title
Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women.
Acronym
SCOUT
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Balearic Islands Health Service (Ibsalut), Instituto de Investigación Sanitaria Aragón, Gerencia de Atención Primaria, Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Randomized clinical trial in which women aged 18 or older and with symptoms of uncomplicated lower urinary tract infection and a positive urine dipstick analysis will be randomized to one of the following four groups: 2-day 3 g fosfomycin o.d., 3-day pivmecillinam 400 mg. t.i.d, 5-day nitrofurantoin 100 mg t.i.d. or a single dose of 3 g of fosfomycin. Sample: 1,000 patients. Two co-primary endpoints are considered: clinical effectiveness at day 7 and bacteriological eradication at day 14. 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.
Detailed Description
Uncomplicated lower urinary tract infections (LUTI) represent a common problem in primary care. Resistance of uropathogens to common antibiotics has significantly increased in the last years. Current local guidelines recommend the use of a single 3 g dose of fosfomycin for these infections, but most general practitioners prefer short-course therapies to single-dose therapy. No study has compared head-to-head short course antimicrobial agents for uncomplicated LUTIs. Therefore, the aim of this randomized clinical trial is to compare three different short-course antibiotic therapies with single-dose fosfomycin for uncomplicated LUTIs in adult women. This will be a pragmatic, multicenter, parallel group, open randomized trial. Women aged 18 or older and with symptoms of uncomplicated LUTI and a positive urine dipstick analysis will be randomized to one of the following four groups: 2-day 3 g fosfomycin o.d., 3-day pivmecillinam 400 mg. t.i.d, 5-day nitrofurantoin 100 mg t.i.d. or a single dose of 3 g of fosfomycin. Sample: 1,000 patients. Two co-primary endpoints are considered: clinical effectiveness, defined as resolution of symptoms, answered by the patients at day 7, and bacteriological eradication (proportion of patients bacteriologically cured) at day 14. Patients will be given a symptom diary for seven days. 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 3 antibiotics studied will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
Urinary Tract Infections, Women, Patient Outcome Assessment, Bacteriological Eradication, Urinalysis, Anti-Bacterial Agents, Antimicrobial Resistance, Short Course, Primary Health Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
3 short-course antibiotic regimens and one-dose of fosfomycin
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Short-course fosfomycin
Arm Type
Active Comparator
Arm Description
3 g of fosfomycin once daily for two days (sachets)
Arm Title
Short-course nitrofurantoin
Arm Type
Active Comparator
Arm Description
Five-day nitrofurantoin 100 mg t.i.d. (pills)
Arm Title
Short-course pivmecillinam
Arm Type
Active Comparator
Arm Description
Three-day pivmecillinam 400 mg. t.i.d. (pills)
Arm Title
Single-dose fosfomycin
Arm Type
Active Comparator
Arm Description
Single 3 g dose of fosfomycin (sachet)
Intervention Type
Drug
Intervention Name(s)
Fosfomycin Trometamol Salt
Other Intervention Name(s)
Monurol
Intervention Description
Fosfomycin 3 g 2 sachets, taken orally, once daily for two days
Intervention Type
Drug
Intervention Name(s)
Nitrofurantoin
Other Intervention Name(s)
Furantoin
Intervention Description
Nitrofurantoin 50 mg pills, taken orally, two pills/8 hours, for five days
Intervention Type
Drug
Intervention Name(s)
Pivmecillinam
Other Intervention Name(s)
Selexid
Intervention Description
Pivmecillinam 400 mg pills. taken orally, one pill/8 hours, for three days
Intervention Type
Drug
Intervention Name(s)
Fosfomycin Trometamol Salt
Other Intervention Name(s)
Monurol
Intervention Description
Fosfomycin 3 g one sachet, taken orally, for one day
Primary Outcome Measure Information:
Title
Clinical effectiveness.
Description
Proportion of patients who report being cured, defined as the resolution of the four symptoms, scoring 0 in the symptom diary.
Time Frame
Day 7.
Title
Bacteriological eradication.
Description
Proportion of patients bacteriologically cured, defined as less than 1,000 cfu/ml.
Time Frame
Day 14.
Secondary Outcome Measure Information:
Title
Duration of symptoms.
Description
Number of days until the last day the patient scores 0 in any of the four symptoms.
Time Frame
From baseline visit to day 7.
Title
Bacteriological eradication.
Description
Proportion of patients bacteriologically cured, defined as less than 1,000 cfu/ml.
Time Frame
Day 28.
Title
Relapse rate.
Description
Proportion of patients presenting a relapse of symptoms within the first four weeks after inclusion in the study and timing of relapse of symptoms and/or bacteriuria.
Time Frame
Days 7, 14 and 28.
Title
Reattendance and complication rate.
Description
Proportion of patients re-attending healthcare services and development of complications within the first 4 weeks (i.e. pyelonephritis, urosepsis).
Time Frame
Days 7, 14 and 28.
Title
Adverse event rate.
Description
Proportion of patients presenting adverse and serious adverse events.
Time Frame
Days 7, 14 and 28.
Title
Change in quality of life.
Description
Change in the quality of life by means of the EQ-5D-5L validated questionnaire (Spanish version).
Time Frame
Days 0 and 7.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women of 18 years of age or older, with clinical features of uncomplicated community-acquired lower urinary tract infection including: At least one of four key symptoms of lower urinary tract infection: dysuria, urgency including nycturia, frequency, and suprapubic tenderness that could be attributed to an uncomplicated lower urinary tract infection, and no alternative explanation (i.e. symptoms suggestive of sexually-transmitted infection or vulvovaginitis), and A urine dipstick analysis positive for either nitrites or leukocyte esterase. Exclusion Criteria: Male sex High suspicion of pyelonephritis (i.e. fever ≥ 37.5°C or flank pain/tenderness) Any condition that may lead or predispose to complicated urinary infection (i.e. indwelling urinary catheter, pregnancy, immunosuppressive therapy, abnormal urinary tracts, recurrent urinary tract infection, severe neurological disease affecting the bladder) Pregnancy or planned pregnancy Symptoms consistent with urinary tract infection in the preceding 4 weeks Patients taking long-term antibiotic prophylaxis Ongoing antibiotic therapy or use of any systemic antibiotic in the previous 7 days Symptoms correlating with differential diagnosis (i.e. vaginal discharge or pain) Hypersensitivity or allergy to β lactams, nitrofurantoin and/or fosfomycin Moderate to severe chronic renal insufficiency Pre-existing polyneuropathy History of lung or liver reaction or peripheral neuropathy after previous use of nitrofurantoin Glucose-6-phosphate dehydrogenase deficiency Porphyria or systemic primary carnitine deficiency or of the type organic aciduria (i.e. methylmalonic aciduria and propionicacidaemia) Esophageal stricture Current intake of allopurinol or probenecid or valproate Currently part of another randomized clinical trial Previous enrolment in the proposed study Patients living in long-term institutions; and/or Difficulty in conducting scheduled follow-up visits
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Garcia-Sangenís, MD
Phone
0034638687717
Email
agarcia@idiapjgol.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ramon Monfà, MD
Email
rmonfa@idiapjgol.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa Morros, MD PhD
Organizational Affiliation
Pharmacist
Official's Role
Study Chair
Facility Information:
Facility Name
Arrabal Health Center
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
50015
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Magallón Botaya, MD
Phone
0034976731500
Email
med000764@gmail.com
Facility Name
Parque Goya Health Center
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
50018
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cruz Bartolomé Moreno, MD
Phone
+34976765000
Email
cruzbrtlm@gmail.com
Facility Name
Santa Ponça Health Center
City
Calvià
State/Province
Balearic Islands
ZIP/Postal Code
07180
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Ignacio Ramirez Manent, MD
Phone
0034971694345
Facility Name
Escola Graduada Health Center
City
Palma De Mallorca
State/Province
Balearic Islands
ZIP/Postal Code
07002
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoni Ballester Camps, MD
Phone
0034971717049
Facility Name
Camp Redó Health Center
City
Palma De Mallorca
State/Province
Balearic Islands
ZIP/Postal Code
07010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Pou Bordoy, MD
Phone
+34971205551
Facility Name
Son Serra-La Vileta Health Center
City
Palma De Mallorca
State/Province
Balearic Islands
ZIP/Postal Code
07013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catalina Vicens Caldentey, MD
Phone
0034971793193
Facility Name
La Gavarra Health Center
City
Cornellà De Llobregat
State/Province
Catalonia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Cobo, MD
Email
scobo@ambitcp.catsalut.net
Facility Name
Jaume I Health Center
City
Tarragona
State/Province
Catalonia
ZIP/Postal Code
43005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Moragas, MD PhD
Phone
0034600072170
Email
anamaria.moragas@urv.cat
First Name & Middle Initial & Last Name & Degree
Silvia Hernandez, MD PhD
Phone
607811649
Email
silviaha@comt.es
Facility Name
Valleaguado Health Center
City
Coslada
State/Province
Madrid
ZIP/Postal Code
28823
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lidia Escribano González, MD
Phone
0034916690024
Facility Name
San Fernando Health Center
City
San Fernando De Henares
State/Province
Madrid
ZIP/Postal Code
28830
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Benito Ortiz, MD
Phone
0034916691266
Facility Name
Villarejo de Salvanés Health Center
City
Villarejo de Salvanés
State/Province
Madrid
ZIP/Postal Code
28590
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Marín Cañada, MD
Phone
0034918745017
Email
jmarin29@hotmail.com
Facility Name
Los Alpes Health Center
City
Madrid
ZIP/Postal Code
28022
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Victoria Garcia Espinosa, MD
Phone
0034917759109
Facility Name
Aquitania Health Center
City
Madrid
ZIP/Postal Code
28032
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Lor Leandro, MD
Phone
0034913135323

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
On request
IPD Sharing Time Frame
On request after publication.
IPD Sharing Access Criteria
Principal investigator's email (carles.llor@gmail.com)
Citations:
PubMed Identifier
34824124
Citation
Garcia-Sangenis A, Morros R, Aguilar-Sanchez M, Medina-Perucha L, Leiva A, Ripoll J, Martinez-Pecharroman M, Bartolome-Moreno CB, Magallon Botaya R, Marin-Canada J, Molero JM, Moragas A, Troncoso A, Monfa R, Llor C; SCOUT Study Group. 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. BMJ Open. 2021 Nov 25;11(11):e055898. doi: 10.1136/bmjopen-2021-055898.
Results Reference
derived
Links:
URL
http://www.idiapjgol.org/index.php/en/
Description
The protocol of the study will be available on this webpage

Learn more about this trial

Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women.

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