Cystitis AcuteMicUTINCT05667207
Dipsticks and Microscopy to Reduce Antibiotic Use in Women's Urinary Tract Infections: a Pilot Trial (MicUTI)
A study testing Point-of-care microscopy and dipstick guided management in people with Cystitis Acute and Antibiotic Resistant Infection, run by Wuerzburg University Hospital at 2 sites in Germany.
Trial summary
With the aim to pilot a full-scaled trial to reduce unnecessary antibiotics in women with suspected uncomplicated urinary tract infections, twenty general practices in Bavaria, Germany, will be randomized to deliver patient management based on phase-contrast microscopy and urinary dipsticks or to usual care. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cystitis Acute, Antibiotic Resistant Infection, Medication Adherence
- What is being tested?
- Point-of-care microscopy and dipstick guided management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesGermany
- Study dates
- 15 Jun 2023to 30 Apr 2024
- Phase
- Interventional
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with at least two of dysuria, frequency, urgency, lower abdominal pain or hematuria.
Who cannot join
- Signs of a complicated UTI (anamnesis of fever, chills or flank pain)
- Clinically relevant immunosuppression (i.e., current use of any immunosup-pressive therapy, congenital or acquired disorders of immunity)
- Acute or chronic functional or anatomical variations in urinary tract except renal insufficiency grade II/IIIa
- Permanent bladder catheter or use of bladder catheter within the past two weeks
- UTI within the past two weeks
- Use of any antibiotic within the past two weeks
Show all 11Show fewer
- Accommodation in a nursing home or hospital stay within the past two weeks
- Severe neurologic or psychiatric illness, severe dementia or severe substance use disorder
- Other severe diseases
- Being unable to understand the informed consent or to complete the patient diary
- Known pregnancy
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Stefanie Stark
Erlangen, 91054
University Hospital Würzburg
Würzburg, 97080
About this study
Official title: Dipsticks and Point-of-care Microscopy to Reduce Antibiotic Use in Women With Uncomplicated Urinary Tract Infections: a Cluster-randomized Controlled Pilot Trial
With the aim to pilot a full-scaled trial to reduce unnecessary antibiotics in women with suspected uncomplicated urinary tract infections, twenty general practices in Bavaria, Germany, will be randomized to deliver patient management based on phase-contrast microscopy and urinary dipsticks or to usual care. Primary endpoints are recruitment and retention rates.
Read the detailed description
Introduction: Uncomplicated urinary tract infections (UTIs) in women are among the most common infections encountered in primary care after those of the respiratory tract. They are often self-limiting, even though antibiotics are prescribed for almost all women presenting with suggestive clinical features. Efforts directed to tackle antimicrobial resistance led to primary care randomized controlled trials (RCTs) that investigated alternative treatment strategies in these patients. While reducing antibiotic use substantially, none of the experimental treatments showed non-inferiority to antibiotics with respect to clinical outcomes such as symptom duration, symptom burden, and pyelonephritis. Evidence suggests that rapid point-of-care (POC) tests to detect bacteria and erythrocytes in urine at presentation may help primary care clinicians to select women with uncomplicated UTIs (unUTIs) in whom antibiotics can be withheld without affecting clinical outcomes. The aim of this study is to pilot a full-scaled primary care RCT to evaluate the effects of a POC diagnosis and treatment algorithm based on a combination of phase-contrast microscopy and urinary dipsticks on antibiotic use in women with symptoms of an unUTI.
Methods and analysis: MicUTI (Microscopy in UTI) is a pragmatic open-label two -arm parallel pilot cluster-RCT. Twenty general practices affiliated to the Bavarian Practice Based Research Network (BayFoNet) in Germany will be randomly assigned to deliver patient management based on POC-tests (POCTs) or to the usual care arm. Urine samples will be obtained at presentation for POCTs and microbiological analysis. All patients will be followed-up using a self-directed patient diary completed until day 7 from inclusion or until symptom resolution (up to day 14), and through telephone-calls at day 28. An electronic medical record review is performed in case of missing follow-up information.
Primary endpoints are patient enrollment and retention rates. Exploratory endpoints include antibiotic use for UTI at day 28, time to symptom resolution, symptom burden, the number of recurrent and upper UTIs and re-consultations, and diagnostic accuracy (POCTs vs. urine culture as reference standard).
Ethics, data protection and trial registration: The trial will be conducted in accordance to the declaration of Helsinki and the relevant data protection regulations. Institutional review board approval: 109/22-sc (December 16, 2022)
- Conditions
- Cystitis Acute, Antibiotic Resistant Infection, Medication Adherence, Urinary Tract Infection Bacterial, Urinary Tract Infection Lower Acute
- Being tested
- Point-of-care microscopy and dipstick guided management
- Keywords
- General Practice, Primary care, randomized controlled trial, randomized clinical trial, cluster-randomized trial, pilot study, feasibility, microscopy, urinary dipsticks, clinical decision algorithm, point-of-care test
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care microscopy and dipstick guided managementDiagnostic test
GPs will be encouraged to apply the following diagnosis and treatment algorithm (figure 1) to consenting women, taking their preferences into account:
- If POCTs are positive for bacteria by microscopy and/or for erythrocytes by dipsticks the GP issues, at his/her own clinical judgement, a delayed or immediate prescription for an antibiotic.10 In the MicUTI intervention, delayed prescription is defined as issuing an antibiotic prescription with the advice to take the medication only when symptoms do not improve or worsen in 48 hours.
- If POCTs are negative for bacteria and erythrocytes, the GP advises for self-help remedies according to guidelines and to do without antibiotics Study specific training in point-of-care microscopy will be provided to intervention practices.
| Study group | Role | What they receive |
|---|---|---|
| Point-of-care microscopy and dipstick guided management | Experimental | GPs whose practice is allocated to the intervention will have their management guided by POCTs, namely phase-contrast microscopy and urinary dipsticks for all patients consenting for participation. Receives: Diagnostic Test: Point-of-care microscopy and dipstick guided management |
| Usual care | No intervention | Practices in the control arm will not have their management guided by POCTs. They will perform usual care. The treatment decision is usually based on symptoms and dip-stick test results (i.e., erythrocytes, leukocytes, nitrites). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment efficacy
Number of participants enrolled per site over 6 months of trial duration
Measured: 6 months (duration of the trial in each study site)
Retention
Percentage of complete follow-ups over 28 days
Measured: 28 days (duration of the trial for each enrolled patient)
Secondary outcomes (11)
Total antibiotic use
Number of antibiotic prescriptions per patient with UTI within 28 days
Measured: 28 days
Antibiotic doses
Defined daily doses of the prescribed antibiotics per patient with UTI within 28 days
Measured: 28 days
Inappropriate antibiotic use
Percentage of patients with symptoms of UTI who were prescribed antibiotics among those with negative urine cultures
Measured: Day 0
Immediate and delayed antibiotics
Number of immediate and delayed antibiotic prescriptions for uncomplicated UTI at initial consultation
Measured: Day 0
Early relapses
Number of early relapses of UTI (days 0-14)
Measured: Days 0-14
Recurrent urinary tract infections (UTIs)
Number of recurrent UTIs (day 15-28)
Measured: Days 15-28
Upper UTIs
Number of upper UTIs within 28 days
Measured: 28 days
Re-consultations
Number of consultations due to UTI (or symptoms of UTI) within 28 days
Measured: 28 days
Symptom resolution
Time to symptom resolution defined as a maximum of 1 point in each of the UTI-SIQ-8 items
Measured: Days 0-7 (or max. 14 if symptoms last longer)
Symptom Burden
Total symptom burden on days 0-7 (area under the curve of the UTI-SIQ-8 total symptom score)
Measured: Days 0-14
Diagnostic accuracy
Diagnostic accuracy of microscopy +/- dipstick compared to the standard (urine culture)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start15 Jun 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cystitis AcuteStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study (feasibility)
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Erlangen, LMU Klinikum, University of Bristol, University of Santiago de Compostela, Università degli Studi di Trento, University of Wuerzburg, University of Georgia
- Responsible party
- Sponsor
- Investigators
- Ildikó Gágyor, Professor, Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667207
- Sponsor's protocol ID
- 109/22-sc
- Acronym
- MicUTI
- Status last verified
- Nov 2023
- First submitted
- 19 Dec 2022
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kurotschka PK, Borgulya G, Bucher E, Endrich I, Figueiras A, Gensichen J, Hay AD, Hapfelmeier A, Kretzschmann C, Kurzai O, Lam TT, Massidda O, Sanftenberg L, Schmiemann G, Schneider A, Simmenroth A, Stark S, Warkentin L, Ebell MH, Gagyor I; Bavarian Practice-Based Research Network (BayFoNet). Dipsticks and point-of-care Microscopy to reduce antibiotic use in women with an uncomplicated Urinary Tract Infection (MicUTI): protocol of a randomised controlled pilot trial in primary care. BMJ Open. 2024 Mar 29;14(3):e079345. doi: 10.1136/bmjopen-2023-079345.
PubMed 38553055Kurotschka PK, Koch MJ, Bucher E, Figueiras A, Gensichen J, Hapfelmeier A, Hay AD, Kretzschmann C, Kurzai O, Lam TT, Lasher K, Massidda O, Sanftenberg L, Schmiemann G, Schneider A, Simmenroth A, Stark S, Warkentin L, Ebell MH, Gagyor I; Bavarian Practice-Based Research Network (BayFoNet). Dipsticks and point-of-care Microscopy in Urinary Tract Infections in primary care: Results of the MicUTI pilot cluster randomised controlled trial. PLoS One. 2025 Oct 8;20(10):e0332390. doi: 10.1371/journal.pone.0332390. eCollection 2025.
PubMed 41060972Sanftenberg L, Schnaidt AL, Eck S, Schneider A, Bucher E, Kurotschka PK, Gagyor I, Klanke M, Stark S, Kuhlein T, Walter F, Roos M, Dreischulte T, Gensichen J; BayFoNet study group. Experiences of general practice teams and their patients with clinical research-a mixed-methods process evaluation of the Bavarian Research Practice Network (BayFoNet). BMC Prim Care. 2025 Feb 28;26(1):59. doi: 10.1186/s12875-025-02744-x.
PubMed 40021995Sanftenberg L, Stofella J, Mayr K, Nassehi A, Hardtlein A, Stark S, Kuhlein T, Kurotschka PK, Gagyor I, Eck S, Schneider A, Bossenecker M, Roos M, Dreischulte T, Gensichen J; BayFoNet study group. Expectations of general practitioners on a practice based research network in Germany- a qualitative study within the Bavarian Research Practice Network (BayFoNet). BMC Prim Care. 2024 Jan 2;25(1):10. doi: 10.1186/s12875-023-02239-7.
PubMed 38166677Sanftenberg L, Dreischulte T, Hardtlein A, Kosub H, Gagyor I, Kurotschka PK, Kuhlein T, Burggraf L, Eck S, Roos M, Gensichen J; BayFoNet-Research-Group. Process evaluation in practice based research networks: a study protocol for a mixed-methods implementation study. BMJ Open. 2023 Jul 12;13(7):e065947. doi: 10.1136/bmjopen-2022-065947.
PubMed 37438058
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dipsticks and Point-of-care Microscopy to Reduce Antibiotic Use in Women With Uncomplicated Urinary Tract Infections: a Cluster-randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT05667207
- Acronym / sponsor ID
- MicUTI / 109/22-sc
- Conditions
- Cystitis Acute, Antibiotic Resistant Infection, Medication Adherence, Urinary Tract Infection Bacterial, Urinary Tract Infection Lower Acute
- Keywords
- General Practice, Primary care, randomized controlled trial, randomized clinical trial, cluster-randomized trial, pilot study, feasibility, microscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- University Hospital Erlangen, LMU Klinikum, University of Bristol, University of Santiago de Compostela, Università degli Studi di Trento, University of Wuerzburg, University of Georgia
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 28 Dec 2022 (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.
With the aim to pilot a full-scaled trial to reduce unnecessary antibiotics in women with suspected uncomplicated urinary tract infections, twenty general practices in Bavaria, Germany, will be randomized to deliver patient management based on phase-contrast microscopy and urinary dipsticks or to usual care. Primary endpoints are recruitment and retention rates.
Detailed description
Introduction: Uncomplicated urinary tract infections (UTIs) in women are among the most common infections encountered in primary care after those of the respiratory tract. They are often self-limiting, even though antibiotics are prescribed for almost all women presenting with suggestive clinical features. Efforts directed to tackle antimicrobial resistance led to primary care randomized controlled trials (RCTs) that investigated alternative treatment strategies in these patients. While reducing antibiotic use substantially, none of the experimental treatments showed non-inferiority to antibiotics with respect to clinical outcomes such as symptom duration, symptom burden, and pyelonephritis. Evidence suggests that rapid point-of-care (POC) tests to detect bacteria and erythrocytes in urine at presentation may help primary care clinicians to select women with uncomplicated UTIs (unUTIs) in whom antibiotics can be withheld without affecting clinical outcomes. The aim of this study is to pilot a full-scaled primary care RCT to evaluate the effects of a POC diagnosis and treatment algorithm based on a combination of phase-contrast microscopy and urinary dipsticks on antibiotic use in women with symptoms of an unUTI.
Methods and analysis: MicUTI (Microscopy in UTI) is a pragmatic open-label two -arm parallel pilot cluster-RCT. Twenty general practices affiliated to the Bavarian Practice Based Research Network (BayFoNet) in Germany will be randomly assigned to deliver patient management based on POC-tests (POCTs) or to the usual care arm. Urine samples will be obtained at presentation for POCTs and microbiological analysis. All patients will be followed-up using a self-directed patient diary completed until day 7 from inclusion or until symptom resolution (up to day 14), and through telephone-calls at day 28. An electronic medical record review is performed in case of missing follow-up information.
Primary endpoints are patient enrollment and retention rates. Exploratory endpoints include antibiotic use for UTI at day 28, time to symptom resolution, symptom burden, the number of recurrent and upper UTIs and re-consultations, and diagnostic accuracy (POCTs vs. urine culture as reference standard).
Ethics, data protection and trial registration: The trial will be conducted in accordance to the declaration of Helsinki and the relevant data protection regulations. Institutional review board approval: 109/22-sc (December 16, 2022)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot study (feasibility)
| Arm | Type | Receives |
|---|---|---|
| Point-of-care microscopy and dipstick guided management | Experimental | Diagnostic Test: Point-of-care microscopy and dipstick guided managementGPs whose practice is allocated to the intervention will have their management guided by POCTs, namely phase-contrast microscopy and urinary dipsticks for all patients consenting for participation. |
| Usual care | No intervention | –Practices in the control arm will not have their management guided by POCTs. They will perform usual care. The treatment decision is usually based on symptoms and dip-stick test results (i.e., erythrocytes, leukocytes, nitrites). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with at least two of dysuria, frequency, urgency, lower abdominal pain or hematuria.
Key exclusion criteria (11 listed)
- Signs of a complicated UTI (anamnesis of fever, chills or flank pain)
- Clinically relevant immunosuppression (i.e., current use of any immunosup-pressive therapy, congenital or acquired disorders of immunity)
- Acute or chronic functional or anatomical variations in urinary tract except renal insufficiency grade II/IIIa
- Permanent bladder catheter or use of bladder catheter within the past two weeks
- UTI within the past two 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 |
|---|---|---|
| Point-of-care microscopy and dipstick guided managementGPs will be encouraged to apply the following diagnosis and treatment algorithm (figure 1) to consenting women, taking their preferences into account: 1. If POCTs are positive for bacteria by microscopy and/or for erythrocytes by dipsticks the GP issues, at his/her own clinical judgement, a delayed or immediate prescription for an antibiotic.10 In the MicUTI intervention, delayed prescription is defined as issuing an antibiotic prescription with the advice to take the medication only when symptoms do not improve or worsen in 48 hours. 2. If POCTs are negative for bacteria and erythrocytes, the GP advises for self-help remedies according to guidelines and to do without antibiotics Study specific training in point-of-care microscopy will be provided to intervention practices. | Diagnostic test | Point-of-care microscopy and dipstick guided management |
Primary outcome
Recruitment efficacy
Time frame: 6 months (duration of the trial in each study site)
Number of participants enrolled per site over 6 months of trial duration
Retention
Time frame: 28 days (duration of the trial for each enrolled patient)
Percentage of complete follow-ups over 28 days
11 secondary outcomes
Total antibiotic use
Time frame: 28 days
Antibiotic doses
Time frame: 28 days
Inappropriate antibiotic use
Time frame: Day 0
Immediate and delayed antibiotics
Time frame: Day 0
Early relapses
Time frame: Days 0-14
Recurrent urinary tract infections (UTIs)
Time frame: Days 15-28
Upper UTIs
Time frame: 28 days
Re-consultations
Time frame: 28 days
Symptom resolution
Time frame: Days 0-7 (or max. 14 if symptoms last longer)
Symptom Burden
Time frame: Days 0-14
Diagnostic accuracy
Time frame: Day 0
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 24 Jul 2024.
- Background: PubMed 38553055Kurotschka PK, Borgulya G, Bucher E, Endrich I, Figueiras A, Gensichen J, Hay AD, Hapfelmeier A, Kretzschmann C, Kurzai O, Lam TT, Massidda O, Sanftenberg L, Schmiemann G, Schneider A, Simmenroth A, Stark S, Warkentin L, Ebell MH, Gagyor I; Bavarian Practice-Based Research Network (BayFoNet). Dipsticks and point-of-care Microscopy to reduce antibiotic use in women with an uncomplicated Urinary Tract Infection (MicUTI): protocol of a randomised controlled pilot trial in primary care. BMJ Open. 2024 Mar 29;14(3):e079345. doi: 10.1136/bmjopen-2023-079345.
- Derived from this study: PubMed 41060972Kurotschka PK, Koch MJ, Bucher E, Figueiras A, Gensichen J, Hapfelmeier A, Hay AD, Kretzschmann C, Kurzai O, Lam TT, Lasher K, Massidda O, Sanftenberg L, Schmiemann G, Schneider A, Simmenroth A, Stark S, Warkentin L, Ebell MH, Gagyor I; Bavarian Practice-Based Research Network (BayFoNet). Dipsticks and point-of-care Microscopy in Urinary Tract Infections in primary care: Results of the MicUTI pilot cluster randomised controlled trial. PLoS One. 2025 Oct 8;20(10):e0332390. doi: 10.1371/journal.pone.0332390. eCollection 2025.
- Derived from this study: PubMed 40021995Sanftenberg L, Schnaidt AL, Eck S, Schneider A, Bucher E, Kurotschka PK, Gagyor I, Klanke M, Stark S, Kuhlein T, Walter F, Roos M, Dreischulte T, Gensichen J; BayFoNet study group. Experiences of general practice teams and their patients with clinical research-a mixed-methods process evaluation of the Bavarian Research Practice Network (BayFoNet). BMC Prim Care. 2025 Feb 28;26(1):59. doi: 10.1186/s12875-025-02744-x.
- Derived from this study: PubMed 38166677Sanftenberg L, Stofella J, Mayr K, Nassehi A, Hardtlein A, Stark S, Kuhlein T, Kurotschka PK, Gagyor I, Eck S, Schneider A, Bossenecker M, Roos M, Dreischulte T, Gensichen J; BayFoNet study group. Expectations of general practitioners on a practice based research network in Germany- a qualitative study within the Bavarian Research Practice Network (BayFoNet). BMC Prim Care. 2024 Jan 2;25(1):10. doi: 10.1186/s12875-023-02239-7.
- Derived from this study: PubMed 37438058Sanftenberg L, Dreischulte T, Hardtlein A, Kosub H, Gagyor I, Kurotschka PK, Kuhlein T, Burggraf L, Eck S, Roos M, Gensichen J; BayFoNet-Research-Group. Process evaluation in practice based research networks: a study protocol for a mixed-methods implementation study. BMJ Open. 2023 Jul 12;13(7):e065947. doi: 10.1136/bmjopen-2022-065947.
- Study ProtocolLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ildikó Gágyor, Professor principal investigator
Wuerzburg University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care microscopy and dipstick guided management in people with Cystitis Acute and Antibiotic Resistant Infection, run by Wuerzburg University Hospital at 2 sites in Germany.
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 1 inclusion and 11 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 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
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?
Recruitment efficacy (time frame: 6 months (duration of the trial in each study site)). 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 NCT05667207, which also lists 5 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 24 Jul 2024.