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

NCT04959331 | Completed Phase 4 DMC

• 1 other identifier: IJG-SCOUT-2021
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 33

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.

Conditions

Urinary Tract Infections

Keywords

Urinary Tract Infections; Women; Patient Outcome Assessment; Bacteriological Eradication; Urinalysis; Anti-Bacterial Agents; Antimicrobial Resistance; Short Course; Primary Health Care

Outcome Measures

Primary Outcomes (2)

• Clinical effectiveness.

  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.

  Proportion of patients bacteriologically cured, defined as less than 1,000 colony forming units (cfu)/ml.

  Day 14.

Secondary Outcomes (6)

• Duration of symptoms.

  From baseline visit to day 7.

• Bacteriological eradication.

  Day 28.

• Relapse rate.

  Days 7, 14 and 28.

• Reattendance and complication rate.

  Days 7, 14 and 28.

• Adverse event rate.

  Days 7, 14 and 28.

Study Arms (4)

Short-course fosfomycin

ACTIVE COMPARATOR

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

Drug: Fosfomycin Trometamol Salt

Short-course nitrofurantoin

ACTIVE COMPARATOR

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

Drug: Nitrofurantoin

Short-course pivmecillinam

ACTIVE COMPARATOR

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

Drug: Pivmecillinam

Single-dose fosfomycin

ACTIVE COMPARATOR

Single 3 g dose of fosfomycin (sachet)

Drug: Fosfomycin Trometamol Salt

Interventions

Fosfomycin Trometamol Salt DRUG

Fosfomycin 3 g 2 sachets, taken orally, once daily for two days

Also known as: Monurol

Short-course fosfomycin

Nitrofurantoin DRUG

Nitrofurantoin 50 mg pills, taken orally, two pills/8 hours, for five days

Also known as: Furantoin

Short-course nitrofurantoin

Pivmecillinam DRUG

Pivmecillinam 400 mg pills. taken orally, one pill/8 hours, for three days

Also known as: Selexid

Short-course pivmecillinam

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Balearic Islands Health Service (Ibsalut): collaborator
• Instituto de Investigación Sanitaria Aragón: collaborator
• Gerencia de Atención Primaria, Madrid: collaborator

Study Sites (33)

Calatayud Center

Calatayud, Aragon, 50300, Spain

Location

Las Fuentes Center

Zaragoza, Aragon, 50002, Spain

Location

Arrabal Health Center

Zaragoza, Aragon, 50015, Spain

Location

Parque Goya Health Center

Zaragoza, Aragon, 50018, Spain

Location

Santa Ponça Health Center

Calvià, Balearic Islands, 07180, Spain

Location

Emili Darder Center

Palma de Mallorca, Balearic Islands, 07007, Spain

Location

Camp Redó Health Center

Palma de Mallorca, Balearic Islands, 07010, Spain

Location

Son Pisà Center

Palma de Mallorca, Balearic Islands, 07011, Spain

Location

Son Serra-La Vileta Health Center

Palma de Mallorca, Balearic Islands, 07013, Spain

Location

Santa Maria del Camí Center

Santa Maria del Camí, Balearic Islands, 07320, Spain

Location

Banyoles Center

Banyoles, Catalonia, 17820, Spain

Location

Corbera Center

Corbera de Llobregat, Catalonia, 08757, Spain

Location

La Gavarra Health Center

Cornellà de Llobregat, Catalonia, 08940, Spain

Location

17 de Setembre Center

el Prat de Llobregat, Catalonia, 08820, Spain

Location

Can Vidalet Center

Esplugues de Llobregat, Catalonia, 08950, Spain

Location

Santa Clara Center

Girona, Catalonia, 17001, Spain

Location

Florida Center

L'Hospitalet de Llobregat, Catalonia, 08905, Spain

Location

Can Serra Center

L'Hospitalet de Llobregat, Catalonia, 08906, Spain

Location

Montblanc Center

Montblanc, Catalonia, 43400, Spain

Location

Pere Garau Center

Palma de Mallorca, Catalonia, 07007, Spain

Location

Molí Nou Center

Sant Boi de Llobregat, Catalonia, 08830, Spain

Location

Sant Feliu de Guíxols Center

Sant Feliu de Guíxols, Catalonia, 17220, Spain

Location

Sant Just Desvern Center

Sant Just Desvern, Catalonia, 08960, Spain

Location

Vila Vella Center

Sant Vicenç dels Horts, Catalonia, 08620, Spain

Location

Jaume I Health Center

Tarragona, Catalonia, 43005, Spain

Location

El Puerto Center

Coslada, Madrid, 28821, Spain

Location

Valleaguado Health Center

Coslada, Madrid, 28823, Spain

Location

Los Alpes Health Center

Madrid, Madrid, 28022, Spain

Location

Aquitania Health Center

Madrid, Madrid, 28032, Spain

Location

Mar Báltico Center

Madrid, Madrid, 28033, Spain

Location

Buenos Aires Center

Madrid, Madrid, 28038, Spain

Location

San Fernando Health Center

San Fernando de Henares, Madrid, 28830, Spain

Location

Villarejo de Salvanés Health Center

Villarejo de Salvanés, Madrid, 28590, Spain

Location

Related Publications (1)

• 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.

  PMID: 34824124 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Fosfomycin; Nitrofurantoin; Amdinocillin Pivoxil

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Nitrofurans; Nitro Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amdinocillin; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Rosa Morros, MD PhD

  Pharmacist

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 short-course antibiotic regimens and one-dose of fosfomycin

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 13, 2021
• Study Start: November 2, 2021
• Primary Completion: December 14, 2024
• Study Completion: December 31, 2024
• Last Updated: September 8, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: On request after publication.
• Access Criteria: Principal investigator's email (carles.llor@gmail.com)

Locations

ES (33)