Infection Due to Escherichia ColiPhase 2SETAPNCT02537847
Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Escherichia Coli
A Phase 2 study testing Sitafloxacin and Ertapenem in people with Infection Due to Escherichia Coli and Acute Pyelonephritis, run by Mahidol University at 1 site in Thailand.
Trial summary
The aim of the investigators' study was to evaluate oral and non carbapenem antimicrobial agents which can be used in outpatient for the treatment of non-bacteremic acute pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia coli. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection Due to Escherichia Coli, Acute Pyelonephritis
- What is being tested?
- Sitafloxacin and Ertapenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2012to May 2016
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Acute pyelonephritis by definition
- Positive urine culture for Extended Spectrum Beta Lactamase Escherichia coli ≥105 colony forming unit/mL
- Voluntarily consented to be enrolled in the study
Who cannot join
- Severe sepsis or septic shock
- Mixed organism of urine culture
- Positive blood culture
- Has other source of infection
- Has mechanical abnormality of urinary tract
- Immunocompromised conditions
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- Retained Foley's catheter
- Pregnancy or lactation
- Previous urinary tract infections within 4 weeks
- Contraindicated for fluoroquinolones and carbapenems
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Ramathibodi Hospital
Bangkok, Bangkok, 10400
Chitprasong Malaisri, MD, ++66 89 466 5043, Mchitprasong@yahoo.com
About this study
Official title: A Randomized Controlled Trial of Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Extended-Spectrum ß-lactamase-producing Escherichia Coli
The aim of the investigators' study was to evaluate oral and non carbapenem antimicrobial agents which can be used in outpatient for the treatment of non-bacteremic acute pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia coli. This study was conducted to compare the clinical and bacteriological outcomes of patients with non-bacteremic acute pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia coli who were treated with intravenous (IV) carbapenems followed by oral sitafloxacin or IV ertapenem.
Read the detailed description
A prospective randomized controlled trial of patients with a presumptive diagnosis of acute pyelonephritis caused by Extended Spectrum Beta Lactamase-producing pathogen was performed. Carbapenems was initially given to all patients. After day 3, patients were randomized to receive either oral sitafloxacin (100 mg twice daily) or intravenous ertapenem. The regular course of treatment was completed within 10 days.
- Being tested
- Sitafloxacin, Ertapenem
- Keywords
- Sitafloxacin, Extended-Spectrum ß-lactamase-producing Escherichia coli, Treatment for Acute Pyelonephritis, Ertapenem
- Medical subject headings
- Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitafloxacinDrug
Also called fluoroquinolone
The patients in intervention group will receive carbapenem for the first 3 days then sitafloxacin for 7 days. Total of treatment duration is 10 days.
ErtapenemDrug
Also called carbapenem
Control group will be given ertapenem only for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Sitafloxacin group | Experimental | The first third days of treatment was open label and all patients were given intravenous carbapenems. After day 3, the patients were randomized to either sitafloxacin group or ertapenem group by the use of a computer-generated random number allocation schedule and block size of four. The patients were allocated to the sitafloxacin group or ertapenem group using the sealed envelope method. Receives: Drug: Sitafloxacin |
| control group | Active comparator | Intervention was prescribed ertapenem for patients. Receives: Drug: Ertapenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
no symptoms of urinary tract infection
no fever, dysuria, back pain, nausea and vomiting
Measured: 30 days
Secondary outcomes (1)
no evidence of Extended Spectrum Beta Lactamase Escherichia coli in urine culture
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startNov 2012
- Primary completionSep 2015 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection Due to Escherichia ColiStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chitprasong Malaisri, Mahidol University
- Investigators
- Sasisopin Kiertiburanakul, Study director, Ramathibodi Hospital Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537847
- Sponsor's protocol ID
- Sitafloxacin123
- Acronym
- SETAP
- Status last verified
- Aug 2015
- First submitted
- 2 Aug 2015
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Extended-Spectrum ß-lactamase-producing Escherichia Coli
- ClinicalTrials.gov ID
- NCT02537847
- Acronym / sponsor ID
- SETAP / Sitafloxacin123
- Keywords
- Sitafloxacin, Extended-Spectrum ß-lactamase-producing Escherichia coli, Treatment for Acute Pyelonephritis, Ertapenem
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 2 Sep 2015 (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.
The aim of the investigators' study was to evaluate oral and non carbapenem antimicrobial agents which can be used in outpatient for the treatment of non-bacteremic acute pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia coli. This study was conducted to compare the clinical and bacteriological outcomes of patients with non-bacteremic acute pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia coli who were treated with intravenous (IV) carbapenems followed by oral sitafloxacin or IV ertapenem.
Detailed description
A prospective randomized controlled trial of patients with a presumptive diagnosis of acute pyelonephritis caused by Extended Spectrum Beta Lactamase-producing pathogen was performed. Carbapenems was initially given to all patients. After day 3, patients were randomized to receive either oral sitafloxacin (100 mg twice daily) or intravenous ertapenem. The regular course of treatment was completed within 10 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitafloxacin group | Experimental | Drug: SitafloxacinThe first third days of treatment was open label and all patients were given intravenous carbapenems. After day 3, the patients were randomized to either sitafloxacin group or ertapenem group by the use of a computer-generated random number allocation schedule and block size of four. The patients were allocated to the sitafloxacin group or ertapenem group using the sealed envelope method. |
| control group | Active comparator | Drug: ErtapenemIntervention was prescribed ertapenem for patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- Acute pyelonephritis by definition
- Positive urine culture for Extended Spectrum Beta Lactamase Escherichia coli ≥105 colony forming unit/mL
- Voluntarily consented to be enrolled in the study
Key exclusion criteria (10 listed)
- Severe sepsis or septic shock
- Mixed organism of urine culture
- Positive blood culture
- Has other source of infection
- Has mechanical abnormality of urinary tract
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 |
|---|---|---|
| SitafloxacinAlso: fluoroquinoloneThe patients in intervention group will receive carbapenem for the first 3 days then sitafloxacin for 7 days. Total of treatment duration is 10 days. | Drug | Sitafloxacin group |
| ErtapenemAlso: carbapenemControl group will be given ertapenem only for 10 days. | Drug | control group |
Primary outcome
no symptoms of urinary tract infection
Time frame: 30 days
no fever, dysuria, back pain, nausea and vomiting
1 secondary outcome
no evidence of Extended Spectrum Beta Lactamase Escherichia coli in urine culture
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
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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.
Sasisopin Kiertiburanakul study director
Ramathibodi Hospital Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sitafloxacin and Ertapenem in people with Infection Due to Escherichia Coli and Acute Pyelonephritis, run by Mahidol University at 1 site in Thailand.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chitprasong Malaisri, MD (+66 89 466 5043, Mchitprasong@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
no symptoms of urinary tract infection (time frame: 30 days). 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 2 Sep 2015.