Urinary Tract InfectionsREGATTA IINCT03176563
Observational Follow-up Study of REGATTA
An observational study of Urinary Tract Infections, run by University Medical Center Goettingen at 47 sites in Germany.
Trial summary
Observational follow-up study of patients included in the clinical trial REGATTA. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Arctuvan and Fosfomycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 398 participants
- Where
- 47 sitesGermany
- Study dates
- 3 May 2017to 20 Aug 2019
- Phase
- Observational
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: participants of the clinical trial REGATTA
Who may be able to join
- participants of the clinical trial REGATTA
- informed consent to participate in the observational study REGATTA II
Who cannot join
- no informed consent granted
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Germany47 sites
Hausarztpraxis Dr. Raby
Achim
General Practice Aden
Braunschweig
General Practice Scheffer
Braunschweig
General Practice Coutelle
Bremen
General Practice Schelp
Bremen
General Practice Dickow
Burgwedel
General Practice Kiwit-Putzer
Burgwedel
Praxis Zietz
Celle
General Practice Kutzsche
Emmerthal
Praxis Dr. Bahr
Gieboldehausen
General Practice Müller
Gillersheim
Institute of General Medicine, University Medical Center Goettingen
Goettigen, 37075
General Practice Keske
Göttingen
General Practice Koch
Göttingen
General Practice Kolb
Göttingen
General Practice Lang
Göttingen
General Practice Lückerath
Göttingen
Praxisgemeinschaft Jacob / Kling
Göttingen
Institute of General Medicine, MHH Hannover
Hanover, 30625
General Practice Barth
Hanover
Praxis Dr. Egner
Hanover
General Practice Löber
Hardegsen
Gemeinschaftspraxis Dres Schlesier / Eckhardt
Heilbad Heiligenstadt
Gemeinschaftspraxis Hartleb / Stöcking
Heilbad Heiligenstadt
Praxis Dr. Koch
Heilbad Heiligenstadt
Praxisgemeinschaft Seitz / Eckert
Herzberg am Harz
General Practice Wilde
Hildesheim
General Practice Beverungen
Höxter
Praxisgemeinschaft Stoltz / Raddatz
Höxter
Gemeinschaftspraxis Kasperczyk / Schindewolf-Lensch
Isernhagen-Süd
General Practice Franz
Katlenburg-Lindau
Praxis Dr. Ohlendorf
Langenhagen
General Practice Ertel
Langwedel
General Practice Wehrbein
Lemförde
General Practice Lindenblatt
Neustadt
Hausarztzentrum Nörten
Nörten-Hardenberg
General Practice Preiskorn
Rehburg-Loccum
General Practice Meier-Ahrens
Rosdorf
General Practice Woitschek
Salzgitter
General Practice Beulshausen
Sattenhausen
General Practice Schulte
Scheeßel
General Practice Böttcher
Schwanewede
General Practice Albrecht
Springe
General Practice Wolf
Uslar
General Practice Schmiemann
Verden an der Aller
General Practice Annweiler
Waake
General Practice Stegemann
Wunstorf
About this study
Official title: Observational Study of Patients With Uncomplicated Urinary Tract Infection Treated With Antibiotics or Herbal Medicinal Product
Observational follow-up study of patients included in the clinical trial REGATTA.
Read the detailed description
A follow-up telephone interview of the participants of the clinical trial REGATTA exploring the occurrence of urinary tract infections, pyelonephritis within a follow-up period of three months after inclusion.
- Conditions
- Urinary Tract Infections
- Being tested
- Arctuvan, Placebo to Fosfomycin, Fosfomycin, Placebo to Arctuvan
- Keywords
- herbal treatment, antibiotics, uncomplicated urinary tract infection
- 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.
ArctuvanDrug
application of a herbal drug in the clinical trial REGATTA (NCT03151603)
Placebo to FosfomycinDrug
application of Placebo to Fosfomycin in the clinical trial REGATTA (NCT03151603)
FosfomycinDrug
application of an antibiotic drug in the clinical trial REGATTA (NCT03151603)
Placebo to ArctuvanDrug
application of Placebo to Arctuvan in the clinical trial REGATTA (NCT03151603)
| Study group | Role | What they receive |
|---|---|---|
| Women treated with the herbal drug Uva Ursi | Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the Uva Ursi arm. Receives: Drug: Arctuvan; Drug: Placebo to Fosfomycin | |
| Women treated with antibiotics | Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the fosfomycin arm. Receives: Drug: Fosfomycin; Drug: Placebo to Arctuvan |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of urinary tract infections
number of urinary tract infection within 3 months after inclusion in REGATTA
Measured: 3 months after inclusion in REGATTA
number of pyelonephritis
number of pyelonephritis within 3 months after inclusion in REGATTA
Measured: 3 months after inclusion in REGATTA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start3 May 2017
- Primary completion19 Jul 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karsten Gavenis, University Medical Center Goettingen
- Investigators
- Eva Hummers-Pradier, Prof. Dr., Principal investigator, University Medical Center Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176563
- Sponsor's protocol ID
- 01970
- Acronym
- REGATTA II
- Status last verified
- Nov 2019
- First submitted
- 31 May 2017
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Patients With Uncomplicated Urinary Tract Infection Treated With Antibiotics or Herbal Medicinal Product
- ClinicalTrials.gov ID
- NCT03176563
- Acronym / sponsor ID
- REGATTA II / 01970
- Conditions
- Urinary Tract Infections
- Keywords
- herbal treatment, antibiotics, uncomplicated urinary tract infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 5 Jun 2017 (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.
Observational follow-up study of patients included in the clinical trial REGATTA.
Detailed description
A follow-up telephone interview of the participants of the clinical trial REGATTA exploring the occurrence of urinary tract infections, pyelonephritis within a follow-up period of three months after inclusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women treated with the herbal drug Uva Ursi | – | Drug: Arctuvan, Drug: Placebo to FosfomycinPatients of the clinical trial REGATTA (NCT03151603) who have been randomized in the Uva Ursi arm. |
| Women treated with antibiotics | – | Drug: Fosfomycin, Drug: Placebo to ArctuvanPatients of the clinical trial REGATTA (NCT03151603) who have been randomized in the fosfomycin arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- participants of the clinical trial REGATTA
Key inclusion criteria (2 listed)
- participants of the clinical trial REGATTA
- informed consent to participate in the observational study REGATTA II
Key exclusion criteria (1 listed)
- no informed consent granted
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 |
|---|---|---|
| Arctuvanapplication of a herbal drug in the clinical trial REGATTA (NCT03151603) | Drug | Women treated with the herbal drug Uva Ursi |
| Placebo to Fosfomycinapplication of Placebo to Fosfomycin in the clinical trial REGATTA (NCT03151603) | Drug | Women treated with the herbal drug Uva Ursi |
| Fosfomycinapplication of an antibiotic drug in the clinical trial REGATTA (NCT03151603) | Drug | Women treated with antibiotics |
| Placebo to Arctuvanapplication of Placebo to Arctuvan in the clinical trial REGATTA (NCT03151603) | Drug | Women treated with antibiotics |
Primary outcome
number of urinary tract infections
Time frame: 3 months after inclusion in REGATTA
number of urinary tract infection within 3 months after inclusion in REGATTA
number of pyelonephritis
Time frame: 3 months after inclusion in REGATTA
number of pyelonephritis within 3 months after inclusion in REGATTA
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 27 Nov 2019.
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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. Dr. principal investigator
University Medical Center Göttingen
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by University Medical Center Goettingen at 47 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 2 inclusion and 1 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 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 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?
number of urinary tract infections (time frame: 3 months after inclusion in REGATTA). 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?
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 27 Nov 2019.