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

September 1, 2025 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
    • Aragon
      • Calatayud, Aragon, Spain, 50300
        • Calatayud Center
      • Zaragoza, Aragon, Spain, 50002
        • Las Fuentes Center
      • Zaragoza, Aragon, Spain, 50015
        • Arrabal Health Center
      • Zaragoza, Aragon, Spain, 50018
        • Parque Goya Health Center
    • Balearic Islands
      • Calvià, Balearic Islands, Spain, 07180
        • Santa Ponça Health Center
      • Palma de Mallorca, Balearic Islands, Spain, 07007
        • Emili Darder Center
      • Palma de Mallorca, Balearic Islands, Spain, 07010
        • Camp Redó Health Center
      • Palma de Mallorca, Balearic Islands, Spain, 07011
        • Son Pisà Center
      • Palma de Mallorca, Balearic Islands, Spain, 07013
        • Son Serra-La Vileta Health Center
      • Santa Maria del Camí, Balearic Islands, Spain, 07320
        • Santa Maria del Camí Center
    • Catalonia
      • Banyoles, Catalonia, Spain, 17820
        • Banyoles Center
      • Corbera de Llobregat, Catalonia, Spain, 08757
        • Corbera Center
      • Cornellà de Llobregat, Catalonia, Spain, 08940
        • La Gavarra Health Center
      • Esplugues de Llobregat, Catalonia, Spain, 08950
        • Can Vidalet Center
      • Girona, Catalonia, Spain, 17001
        • Santa Clara Center
      • L'Hospitalet de Llobregat, Catalonia, Spain, 08905
        • Florida Center
      • L'Hospitalet de Llobregat, Catalonia, Spain, 08906
        • Can Serra Center
      • Montblanc, Catalonia, Spain, 43400
        • Montblanc Center
      • Palma de Mallorca, Catalonia, Spain, 07007
        • Pere Garau Center
      • Sant Boi de Llobregat, Catalonia, Spain, 08830
        • Molí Nou Center
      • Sant Feliu de Guíxols, Catalonia, Spain, 17220
        • Sant Feliu de Guíxols Center
      • Sant Just Desvern, Catalonia, Spain, 08960
        • Sant Just Desvern Center
      • Sant Vicenç dels Horts, Catalonia, Spain, 08620
        • Vila Vella Center
      • Tarragona, Catalonia, Spain, 43005
        • Jaume I Health Center
      • el Prat de Llobregat, Catalonia, Spain, 08820
        • 17 de Setembre Center
    • Madrid
      • Coslada, Madrid, Spain, 28821
        • El Puerto Center
      • Coslada, Madrid, Spain, 28823
        • Valleaguado Health Center
      • Madrid, Madrid, Spain, 28022
        • Los Alpes Health Center
      • Madrid, Madrid, Spain, 28032
        • Aquitania Health Center
      • Madrid, Madrid, Spain, 28033
        • Mar Báltico Center
      • Madrid, Madrid, Spain, 28038
        • Buenos Aires Center
      • San Fernando de Henares, Madrid, Spain, 28830
        • San Fernando Health Center
      • Villarejo de Salvanés, Madrid, Spain, 28590
        • Villarejo de Salvanés Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Short-course fosfomycin
3 g of fosfomycin once daily for two days (sachets)
Drug: Fosfomycin Trometamol Salt
Fosfomycin 3 g 2 sachets, taken orally, once daily for two days
Other Names:
  • Monurol
Drug: Fosfomycin Trometamol Salt
Fosfomycin 3 g one sachet, taken orally, for one day
Other Names:
  • Monurol
Active Comparator: Short-course nitrofurantoin
Five-day nitrofurantoin 100 mg t.i.d. (pills)
Drug: Nitrofurantoin
Nitrofurantoin 50 mg pills, taken orally, two pills/8 hours, for five days
Other Names:
  • Furantoin
Active Comparator: Short-course pivmecillinam
Three-day pivmecillinam 400 mg. t.i.d. (pills)
Drug: Pivmecillinam
Pivmecillinam 400 mg pills. taken orally, one pill/8 hours, for three days
Other Names:
  • Selexid
Active Comparator: Single-dose fosfomycin
Single 3 g dose of fosfomycin (sachet)
Drug: Fosfomycin Trometamol Salt
Fosfomycin 3 g 2 sachets, taken orally, once daily for two days
Other Names:
  • Monurol
Drug: Fosfomycin Trometamol Salt
Fosfomycin 3 g one sachet, taken orally, for one day
Other Names:
  • Monurol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical effectiveness.
Time Frame: Day 7.
Proportion of patients who report being cured, defined as the resolution of the four symptoms, scoring 0 in the symptom diary.
Day 7.
Bacteriological eradication.
Time Frame: Day 14.
Proportion of patients bacteriologically cured, defined as less than 1,000 colony forming units (cfu)/ml.
Day 14.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of symptoms.
Time Frame: From baseline visit to day 7.
Number of days until the last day the patient scores 0 in any of the four symptoms.
From baseline visit to day 7.
Bacteriological eradication.
Time Frame: Day 28.
Proportion of patients bacteriologically cured, defined as less than 1,000 cfu/ml.
Day 28.
Relapse rate.
Time Frame: Days 7, 14 and 28.
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.
Days 7, 14 and 28.
Reattendance and complication rate.
Time Frame: Days 7, 14 and 28.
Proportion of patients re-attending healthcare services and development of complications within the first 4 weeks (i.e. pyelonephritis, urosepsis).
Days 7, 14 and 28.
Adverse event rate.
Time Frame: Days 7, 14 and 28.
Proportion of patients presenting adverse and serious adverse events.
Days 7, 14 and 28.
Change in quality of life.
Time Frame: Days 0 and 7.
Change in the quality of life by means of the 5-level EQ-5D version (EQ-5D-5L) validated questionnaire (Spanish version).
Days 0 and 7.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto de Investigación Sanitaria Aragón
Gerencia de Atención Primaria, Madrid
Balearic Islands Health Service (Ibsalut)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Rosa Morros, MD PhD, Pharmacist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IJG-SCOUT-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

On request

IPD Sharing Time Frame

On request after publication.

IPD Sharing Access Criteria

Principal investigator's email (carles.llor@gmail.com)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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