Urinary Tract InfectionsPhase 4SCOUTNCT04959331
Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women.
A Phase 4 study testing Fosfomycin Trometamol Salt, Nitrofurantoin and Pivmecillinam in people with Urinary Tract Infections, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 33 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Fosfomycin Trometamol Salt, Nitrofurantoin and Pivmecillinam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 33 sitesSpain
- Study dates
- 2 Nov 2021to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Spain33 sites
Banyoles Center
Banyoles, Catalonia, 17820
Calatayud Center
Calatayud, Aragon, 50300
Santa Ponça Health Center
Calvià, Balearic Islands, 07180
Corbera Center
Corbera de Llobregat, Catalonia, 08757
La Gavarra Health Center
Cornellà de Llobregat, Catalonia, 08940
El Puerto Center
Coslada, Madrid, 28821
Valleaguado Health Center
Coslada, Madrid, 28823
17 de Setembre Center
el Prat de Llobregat, Catalonia, 08820
Can Vidalet Center
Esplugues de Llobregat, Catalonia, 08950
Santa Clara Center
Girona, Catalonia, 17001
Florida Center
L'Hospitalet de Llobregat, Catalonia, 08905
Can Serra Center
L'Hospitalet de Llobregat, Catalonia, 08906
Los Alpes Health Center
Madrid, Madrid, 28022
Aquitania Health Center
Madrid, Madrid, 28032
Mar Báltico Center
Madrid, Madrid, 28033
Buenos Aires Center
Madrid, Madrid, 28038
Montblanc Center
Montblanc, Catalonia, 43400
Emili Darder Center
Palma de Mallorca, Balearic Islands, 07007
Camp Redó Health Center
Palma de Mallorca, Balearic Islands, 07010
Son Pisà Center
Palma de Mallorca, Balearic Islands, 07011
Son Serra-La Vileta Health Center
Palma de Mallorca, Balearic Islands, 07013
Pere Garau Center
Palma de Mallorca, Catalonia, 07007
San Fernando Health Center
San Fernando de Henares, Madrid, 28830
Molí Nou Center
Sant Boi de Llobregat, Catalonia, 08830
Sant Feliu de Guíxols Center
Sant Feliu de Guíxols, Catalonia, 17220
Sant Just Desvern Center
Sant Just Desvern, Catalonia, 08960
Vila Vella Center
Sant Vicenç dels Horts, Catalonia, 08620
Santa Maria del Camí Center
Santa Maria del Camí, Balearic Islands, 07320
Jaume I Health Center
Tarragona, Catalonia, 43005
Villarejo de Salvanés Health Center
Villarejo de Salvanés, Madrid, 28590
Las Fuentes Center
Zaragoza, Aragon, 50002
Arrabal Health Center
Zaragoza, Aragon, 50015
Parque Goya Health Center
Zaragoza, Aragon, 50018
About this study
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.
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.
Read the 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
- Being tested
- Fosfomycin Trometamol Salt, Nitrofurantoin, Pivmecillinam
- Keywords
- Urinary Tract Infections, Women, Patient Outcome Assessment, Bacteriological Eradication, Urinalysis, Anti-Bacterial Agents, Antimicrobial Resistance, Short Course, Primary Health Care
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosfomycin Trometamol SaltDrug
Also called Monurol
Fosfomycin 3 g 2 sachets, taken orally, once daily for two days
NitrofurantoinDrug
Also called Furantoin
Nitrofurantoin 50 mg pills, taken orally, two pills/8 hours, for five days
PivmecillinamDrug
Also called Selexid
Pivmecillinam 400 mg pills. taken orally, one pill/8 hours, for three days
Fosfomycin Trometamol SaltDrug
Also called Monurol
Fosfomycin 3 g one sachet, taken orally, for one day
| Study group | Role | What they receive |
|---|---|---|
| Short-course fosfomycin | Active comparator | 3 g of fosfomycin once daily for two days (sachets) Receives: Drug: Fosfomycin Trometamol Salt |
| Short-course nitrofurantoin | Active comparator | Five-day nitrofurantoin 100 mg t.i.d. (pills) Receives: Drug: Nitrofurantoin |
| Short-course pivmecillinam | Active comparator | Three-day pivmecillinam 400 mg. t.i.d. (pills) Receives: Drug: Pivmecillinam |
| Single-dose fosfomycin | Active comparator | Single 3 g dose of fosfomycin (sachet) Receives: Drug: Fosfomycin Trometamol Salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effectiveness.
Proportion of patients who report being cured, defined as the resolution of the four symptoms, scoring 0 in the symptom diary.
Measured: Day 7.
Bacteriological eradication.
Proportion of patients bacteriologically cured, defined as less than 1,000 colony forming units (cfu)/ml.
Measured: Day 14.
Secondary outcomes (6)
Duration of symptoms.
Number of days until the last day the patient scores 0 in any of the four symptoms.
Measured: From baseline visit to day 7.
Bacteriological eradication.
Proportion of patients bacteriologically cured, defined as less than 1,000 cfu/ml.
Measured: Day 28.
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.
Measured: Days 7, 14 and 28.
Reattendance and complication rate.
Proportion of patients re-attending healthcare services and development of complications within the first 4 weeks (i.e. pyelonephritis, urosepsis).
Measured: Days 7, 14 and 28.
Adverse event rate.
Proportion of patients presenting adverse and serious adverse events.
Measured: Days 7, 14 and 28.
Change in quality of life.
Change in the quality of life by means of the 5-level EQ-5D version (EQ-5D-5L) validated questionnaire (Spanish version).
Measured: Days 0 and 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start2 Nov 2021
- Primary completion14 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 short-course antibiotic regimens and one-dose of fosfomycin
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Balearic Islands Health Service (Ibsalut), Instituto de Investigación Sanitaria Aragón, Gerencia de Atención Primaria, Madrid
- Responsible party
- Sponsor
- Investigators
- Rosa Morros, MD PhD, Study chair, Pharmacist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959331
- Sponsor's protocol ID
- IJG-SCOUT-2021
- Acronym
- SCOUT
- Status last verified
- Feb 2025
- First submitted
- 5 Jul 2021
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On request
Publications
Llor C, Monfa R, Garcia-Sangenis A, Leiva A, Marin-Canada J, Sanchez-Calavera MA, Moragas A, Aguilar-Sanchez M, Troncoso-Marino A, Rodriguez-Barrientos R, Molero JM, Ouchi D, Miranda-Jimenez C, Fernandez-Garcia S, Morros R. Clinical and bacteriological effectiveness of three different short-course antibiotic regimens and single-dose fosfomycin for uncomplicated lower urinary tract infections in women (SCOUT): a pragmatic, multicentre, open-label, randomised clinical trial. Lancet. 2026 Apr 25;407(10539):1603-1613. doi: 10.1016/S0140-6736(25)02171-3. Epub 2026 Apr 20.
PubMed 42026010Garcia-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.
PubMed 34824124
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04959331
- Acronym / sponsor ID
- SCOUT / IJG-SCOUT-2021
- Conditions
- Urinary Tract Infections
- Keywords
- Urinary Tract Infections, Women, Patient Outcome Assessment, Bacteriological Eradication, Urinalysis, Anti-Bacterial Agents, Antimicrobial Resistance, Short Course
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Balearic Islands Health Service (Ibsalut), Instituto de Investigación Sanitaria Aragón, Gerencia de Atención Primaria, Madrid
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 14 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 3 short-course antibiotic regimens and one-dose of fosfomycin
| Arm | Type | Receives |
|---|---|---|
| Short-course fosfomycin | Active comparator | Drug: Fosfomycin Trometamol Salt3 g of fosfomycin once daily for two days (sachets) |
| Short-course nitrofurantoin | Active comparator | Drug: NitrofurantoinFive-day nitrofurantoin 100 mg t.i.d. (pills) |
| Short-course pivmecillinam | Active comparator | Drug: PivmecillinamThree-day pivmecillinam 400 mg. t.i.d. (pills) |
| Single-dose fosfomycin | Active comparator | Drug: Fosfomycin Trometamol SaltSingle 3 g dose of fosfomycin (sachet) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fosfomycin Trometamol SaltAlso: MonurolFosfomycin 3 g 2 sachets, taken orally, once daily for two days | Drug | Short-course fosfomycin |
| NitrofurantoinAlso: FurantoinNitrofurantoin 50 mg pills, taken orally, two pills/8 hours, for five days | Drug | Short-course nitrofurantoin |
| PivmecillinamAlso: SelexidPivmecillinam 400 mg pills. taken orally, one pill/8 hours, for three days | Drug | Short-course pivmecillinam |
| Fosfomycin Trometamol SaltAlso: MonurolFosfomycin 3 g one sachet, taken orally, for one day | Drug | Single-dose fosfomycin |
Primary outcome
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.
Bacteriological eradication.
Time frame: Day 14.
Proportion of patients bacteriologically cured, defined as less than 1,000 colony forming units (cfu)/ml.
6 secondary outcomes
Duration of symptoms.
Time frame: From baseline visit to day 7.
Bacteriological eradication.
Time frame: Day 28.
Relapse rate.
Time frame: Days 7, 14 and 28.
Reattendance and complication rate.
Time frame: Days 7, 14 and 28.
Adverse event rate.
Time frame: Days 7, 14 and 28.
Change in quality of life.
Time frame: Days 0 and 7.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Derived from this study: PubMed 42026010Llor C, Monfa R, Garcia-Sangenis A, Leiva A, Marin-Canada J, Sanchez-Calavera MA, Moragas A, Aguilar-Sanchez M, Troncoso-Marino A, Rodriguez-Barrientos R, Molero JM, Ouchi D, Miranda-Jimenez C, Fernandez-Garcia S, Morros R. Clinical and bacteriological effectiveness of three different short-course antibiotic regimens and single-dose fosfomycin for uncomplicated lower urinary tract infections in women (SCOUT): a pragmatic, multicentre, open-label, randomised clinical trial. Lancet. 2026 Apr 25;407(10539):1603-1613. doi: 10.1016/S0140-6736(25)02171-3. Epub 2026 Apr 20.
- Derived from this study: PubMed 34824124Garcia-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.
- Individual participant dataSharing planned: Yes. On request
Related trials for Urinary Tract Infections
Recruiting
Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
Urinary Tract Infections
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Morros, MD PhD study chair
Pharmacist
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fosfomycin Trometamol Salt, Nitrofurantoin and Pivmecillinam in people with Urinary Tract Infections, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 33 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical effectiveness. (time frame: Day 7.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04959331, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.