Urinary Tract InfectionPhase 4NCT01488955
Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - ICUTI
A Phase 4 study testing Ibuprofen and Fosfomycin-Trometamol in people with Urinary Tract Infection, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 2 sites in Germany.
Trial summary
In this study, patients with uncomplicated urinary infection are investigated. It is investigated if treatment of only symptoms of the uncomplicated urinary infection is as effective as treatment with antibiotics with respect to the outcome of the urinary infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Ibuprofen and Fosfomycin-Trometamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2012to Jul 2014
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women (18 - 65 years)
- Symptoms of uncomplicated urinary tract infection: dysuria, frequency/urgency of micturition, and/or low abdominal pain
- written informed consent
Who cannot join
- fever (> 38,0)
- pain on renal bed percussion
- signs of complicated urinary tract infection
- urinary tract infection within the last two weeks
- antibiotic intake within the last 7 days
- repeated intake of pain medication (i.e. ibuprofen, diclofenac) within the last 24 hours, or continuous pain medication
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- known pregnancy/lactation period
- current immunosuppressive therapy
- known renal insufficiency
- known renal abnormalities
- current urine catheterization
- serious neurological diseases
- limited condition due to other disorders
- contraindications towards trial medication
- current/anamnestic gastrointestinal haemorrhagia
- known allergy towards trial medication
- current intake of drugs potentially interacting with trial medication (i.e. oral corticosteroids, anticoagulates)
- poor communication/cooperation skills
- disability to understand trial information, poor German language skills
- current participation in another clinical trial or clinical trial participation within the last 4 weeks
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Univercity Medical Center Goettingen
Göttingen, 37073
MHH Hannover
Hanover, 30625
About this study
Official title: Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - a Comparative Effectiveness Study in General Practice (ICUTI)
In this study, patients with uncomplicated urinary infection are investigated. It is investigated if treatment of only symptoms of the uncomplicated urinary infection is as effective as treatment with antibiotics with respect to the outcome of the urinary infection. If this is the case, the use of antibiotics in the treatment of uncomplicated urinary infections might be reduced.
Secondary aim of the study is the safety evaluation of both treatment strategies with respect to SAEs during treatment. Additionally, relapse frequency after 28 days is evaluated.
- Conditions
- Urinary Tract Infection
- Being tested
- Ibuprofen, Fosfomycin-Trometamol
- Keywords
- bacterial infection
- Medical subject headings
- Urinary Tract Infections, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
400 mg oral once a day from day 0 for 3 days
Fosfomycin-TrometamolDrug
Also called Monuril
8 g granulate with 3 g Fosfomycin-Trometamol oral once at day 0, placebo to Ibuprofen once a day oral from day 0 for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | Ibuprofen 400 mg oral once daily from day 0 for 3 days, placebo granulate oral day 0 Receives: Drug: Ibuprofen |
| Fosfomycin-Trometamol | Experimental | Fosfomycin-Trometamol (Monuril) 3 g granulate oral at day 0, placebo to Ibuprofen once a day from day 0 for 3 days Receives: Drug: Fosfomycin-Trometamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of additional treatments with antibiotics combined with number of symptoms
The study outcome is considered as positive, if the interventional group where only symptoms were treated has less additional treatments with antibiotics as the interventional group, where antibiotics are given from day 0 on. Additionally, the interventional group where only symptoms were treated has to be non inferior with respect to number of symptoms.
Measured: day 0-28
Secondary outcomes (8)
number of defined daily doses of antibiotics
Measured: day 0-28
number of SAEs
Measured: day 0-28
number of relapses
Measured: day 0-28
number of patients without symptoms
Measured: day 4 and day 7
symptom load (AUC)
Measured: day 0-4
symptom load
Measured: day 0-7
symptoms load with regard to specific symptoms
Measured: day 0-7
activity impairment assessment
Measured: day 0-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startFeb 2012
- Primary completionFeb 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Goettingen
- Responsible party
- Sponsor
- Investigators
- Eva Hummers-Pradier, Prof., Principal investigator, Abt. Allgemeinmedizin, Universitätsmedizin Göttingen, Humboldtallee 38, 37073 Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488955
- Sponsor's protocol ID
- 20110512-BG
- Status last verified
- Aug 2014
- First submitted
- 7 Dec 2011
- Last updated
- 8 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sachdeva A, Rai BP, Veeratterapillay R, Harding C, Nambiar A. Non-steroidal anti-inflammatory drugs for treating symptomatic uncomplicated urinary tract infections in non-pregnant adult women. Cochrane Database Syst Rev. 2024 Dec 19;12(12):CD014762. doi: 10.1002/14651858.CD014762.pub2.
PubMed 39698942Gagyor I, Bleidorn J, Kochen MM, Schmiemann G, Wegscheider K, Hummers-Pradier E. Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial. BMJ. 2015 Dec 23;351:h6544. doi: 10.1136/bmj.h6544.
PubMed 26698878Gagyor I, Hummers-Pradier E, Kochen MM, Schmiemann G, Wegscheider K, Bleidorn J. Immediate versus conditional treatment of uncomplicated urinary tract infection - a randomized-controlled comparative effectiveness study in general practices. BMC Infect Dis. 2012 Jun 28;12:146. doi: 10.1186/1471-2334-12-146.
PubMed 22742538
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - a Comparative Effectiveness Study in General Practice (ICUTI)
- ClinicalTrials.gov ID
- NCT01488955
- Acronym / sponsor ID
- 20110512-BG
- Conditions
- Urinary Tract Infection
- Keywords
- bacterial infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbHUniversity, hospital or other
- Collaborators
- University Medical Center Goettingen
- Study start
- Feb 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 8 Dec 2011 (estimated)
- 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.
In this study, patients with uncomplicated urinary infection are investigated. It is investigated if treatment of only symptoms of the uncomplicated urinary infection is as effective as treatment with antibiotics with respect to the outcome of the urinary infection. If this is the case, the use of antibiotics in the treatment of uncomplicated urinary infections might be reduced.
Secondary aim of the study is the safety evaluation of both treatment strategies with respect to SAEs during treatment. Additionally, relapse frequency after 28 days is evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: IbuprofenIbuprofen 400 mg oral once daily from day 0 for 3 days, placebo granulate oral day 0 |
| Fosfomycin-Trometamol | Experimental | Drug: Fosfomycin-TrometamolFosfomycin-Trometamol (Monuril) 3 g granulate oral at day 0, placebo to Ibuprofen once a day from day 0 for 3 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women (18 - 65 years)
- Symptoms of uncomplicated urinary tract infection: dysuria, frequency/urgency of micturition, and/or low abdominal pain
- written informed consent
Key exclusion criteria (20 listed)
- fever (> 38,0)
- pain on renal bed percussion
- signs of complicated urinary tract infection
- urinary tract infection within the last two weeks
- antibiotic intake within the last 7 days
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 |
|---|---|---|
| Ibuprofen400 mg oral once a day from day 0 for 3 days | Drug | Ibuprofen |
| Fosfomycin-TrometamolAlso: Monuril8 g granulate with 3 g Fosfomycin-Trometamol oral once at day 0, placebo to Ibuprofen once a day oral from day 0 for 3 days | Drug | Fosfomycin-Trometamol |
Primary outcome
number of additional treatments with antibiotics combined with number of symptoms
Time frame: day 0-28
The study outcome is considered as positive, if the interventional group where only symptoms were treated has less additional treatments with antibiotics as the interventional group, where antibiotics are given from day 0 on. Additionally, the interventional group where only symptoms were treated has to be non inferior with respect to number of symptoms.
8 secondary outcomes
number of defined daily doses of antibiotics
Time frame: day 0-28
number of SAEs
Time frame: day 0-28
number of relapses
Time frame: day 0-28
number of patients without symptoms
Time frame: day 4 and day 7
symptom load (AUC)
Time frame: day 0-4
symptom load
Time frame: day 0-7
symptoms load with regard to specific symptoms
Time frame: day 0-7
activity impairment assessment
Time frame: day 0-7
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 Aug 2014.
- Derived from this study: PubMed 39698942Sachdeva A, Rai BP, Veeratterapillay R, Harding C, Nambiar A. Non-steroidal anti-inflammatory drugs for treating symptomatic uncomplicated urinary tract infections in non-pregnant adult women. Cochrane Database Syst Rev. 2024 Dec 19;12(12):CD014762. doi: 10.1002/14651858.CD014762.pub2.
- Derived from this study: PubMed 26698878Gagyor I, Bleidorn J, Kochen MM, Schmiemann G, Wegscheider K, Hummers-Pradier E. Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial. BMJ. 2015 Dec 23;351:h6544. doi: 10.1136/bmj.h6544.
- Derived from this study: PubMed 22742538Gagyor I, Hummers-Pradier E, Kochen MM, Schmiemann G, Wegscheider K, Bleidorn J. Immediate versus conditional treatment of uncomplicated urinary tract infection - a randomized-controlled comparative effectiveness study in general practices. BMC Infect Dis. 2012 Jun 28;12:146. doi: 10.1186/1471-2334-12-146.
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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.
Eva Hummers-Pradier, Prof. principal investigator
Abt. Allgemeinmedizin, Universitätsmedizin Göttingen, Humboldtallee 38, 37073 Göttingen
2 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 Ibuprofen and Fosfomycin-Trometamol in people with Urinary Tract Infection, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH 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 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 Aug 2014. 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.
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?
number of additional treatments with antibiotics combined with number of symptoms (time frame: day 0-28). 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 NCT01488955, which also lists 3 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 Aug 2014.