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

NCT ID: NCT04959331

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2024-12-31

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.

Conditions

Urinary Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Short-course fosfomycin

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

Group Type: ACTIVE_COMPARATOR

Fosfomycin Trometamol Salt

Intervention Type: DRUG

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

Short-course nitrofurantoin

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

Group Type: ACTIVE_COMPARATOR

Nitrofurantoin

Intervention Type: DRUG

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

Short-course pivmecillinam

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

Group Type: ACTIVE_COMPARATOR

Pivmecillinam

Intervention Type: DRUG

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

Single-dose fosfomycin

Single 3 g dose of fosfomycin (sachet)

Group Type: ACTIVE_COMPARATOR

Fosfomycin Trometamol Salt

Intervention Type: DRUG

Fosfomycin 3 g one sachet, taken orally, for one day

Interventions

Fosfomycin Trometamol Salt

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

Intervention Type: DRUG

Nitrofurantoin

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

Intervention Type: DRUG

Pivmecillinam

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

Intervention Type: DRUG

Fosfomycin Trometamol Salt

Fosfomycin 3 g one sachet, taken orally, for one day

Intervention Type: DRUG

Other Intervention Names

Monurol; Furantoin; Selexid; Monurol

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Balearic Islands Health Service (Ibsalut)

OTHER

Sponsor Role: collaborator

Instituto de Investigación Sanitaria Aragón

OTHER

Sponsor Role: collaborator

Gerencia de Atención Primaria, Madrid

OTHER_GOV

Sponsor Role: collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rosa Morros, MD PhD

Role: STUDY_CHAIR

Pharmacist

Locations

Calatayud Center

Calatayud, Aragon, Spain

Las Fuentes Center

Zaragoza, Aragon, Spain

Arrabal Health Center

Zaragoza, Aragon, Spain

Parque Goya Health Center

Zaragoza, Aragon, Spain

Santa Ponça Health Center

Calvià, Balearic Islands, Spain

Emili Darder Center

Palma de Mallorca, Balearic Islands, Spain

Camp Redó Health Center

Palma de Mallorca, Balearic Islands, Spain

Son Pisà Center

Palma de Mallorca, Balearic Islands, Spain

Son Serra-La Vileta Health Center

Palma de Mallorca, Balearic Islands, Spain

Santa Maria del Camí Center

Santa Maria del Camí, Balearic Islands, Spain

Banyoles Center

Banyoles, Catalonia, Spain

Corbera Center

Corbera de Llobregat, Catalonia, Spain

La Gavarra Health Center

Cornellà de Llobregat, Catalonia, Spain

17 de Setembre Center

el Prat de Llobregat, Catalonia, Spain

Can Vidalet Center

Esplugues de Llobregat, Catalonia, Spain

Santa Clara Center

Girona, Catalonia, Spain

Florida Center

L'Hospitalet de Llobregat, Catalonia, Spain

Can Serra Center

L'Hospitalet de Llobregat, Catalonia, Spain

Montblanc Center

Montblanc, Catalonia, Spain

Pere Garau Center

Palma de Mallorca, Catalonia, Spain

Molí Nou Center

Sant Boi de Llobregat, Catalonia, Spain

Sant Feliu de Guíxols Center

Sant Feliu de Guíxols, Catalonia, Spain

Sant Just Desvern Center

Sant Just Desvern, Catalonia, Spain

Vila Vella Center

Sant Vicenç dels Horts, Catalonia, Spain

Jaume I Health Center

Tarragona, Catalonia, Spain

El Puerto Center

Coslada, Madrid, Spain

Valleaguado Health Center

Coslada, Madrid, Spain

Los Alpes Health Center

Madrid, Madrid, Spain

Aquitania Health Center

Madrid, Madrid, Spain

Mar Báltico Center

Madrid, Madrid, Spain

Buenos Aires Center

Madrid, Madrid, Spain

San Fernando Health Center

San Fernando de Henares, Madrid, Spain

Villarejo de Salvanés Health Center

Villarejo de Salvanés, Madrid, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 34824124 (View on PubMed)

Other Identifiers

IJG-SCOUT-2021

Identifier Type: -

Identifier Source: org_study_id