Kidney TransplantationPhase 2NCT02575495
A Randomized Control Trial of Antibiotic Treatment Duration For Asymptomatic Bacteriuria After Kidney Transplantation
A Phase 2 study testing 7 days course of antibiotic treatment and 14 days course of antibiotic treatment in people with Kidney Transplantation and Bacteriuria, run by Mahidol University at 1 site in Thailand.
Trial summary
The major hypothesis to be tested is that there was no difference in the clinical outcome between 7(short-course) and 14(traditional-course) days of antibiotic treatment for asymptomatic bacteriuria early after kidney transplantation. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Kidney Transplantation, Bacteriuria, Asymptomatic Infections
- What is being tested?
- 7 days course of antibiotic treatment and 14 days course of antibiotic treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2015to Feb 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First kidney transplantation
- Asymptomatic bacteriuria
Who cannot join
- Refusal to participate in the study
- Re-transplantation or combined organ transplantation
- History of abnormal structure or function in native kidney, ureter and bladder system
- Kidney transplant recipients with history of recurrent urinary tract infection or incomplete course of urinary tract infection treatment before transplantation
- Hemodynamic unstable
- Urosepsis or other serious infectious complications(eg. symptomatic urinary tract infection/graft pyelonephritis, surgical site infection, infected urinoma/ hospital acquired pneumonia that mandates antibiotic therapy)
- Surgical complication (eg. anastomosis leakage, collection, ureteric stricture)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Control Study of Shortening Antibiotic Treatment Duration For Asymptomatic Bacteriuria Within A Month After Kidney Transplantation
The major hypothesis to be tested is that there was no difference in the clinical outcome between 7(short-course) and 14(traditional-course) days of antibiotic treatment for asymptomatic bacteriuria early after kidney transplantation.
Read the detailed description
Introduction: Treatment of asymptomatic bacteriuria is a common practice in renal transplant centers leading to prolong exposure of antimicrobial agents with long hospital length of stay. The duration of antibiotics treatment in this condition have never been proposed.
Objective: To evaluate the proper duration of antibiotic treatment for asymptomatic bacteriuria early (less than 1 month) after kidney transplantation
Method: This is a prospective, randomized, open labeled, single center study using intention to treat analysis. Patients will be identified and after informed consent is obtained, will be randomized to receive 7 or 14 days course of antibiotics.
- Conditions
- Kidney Transplantation, Bacteriuria, Asymptomatic Infections
- Being tested
- 7 days course of antibiotic treatment, 14 days course of antibiotic treatment
- Medical subject headings
- Bacteriuria, Asymptomatic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 days course of antibiotic treatmentDrug
Also called short-course antibiotic treatment
start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 7 days
14 days course of antibiotic treatmentDrug
Also called traditional-course antibiotic treatment
start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 7 days course of antibiotic treatment | Experimental | To assign the 7 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture Receives: Drug: 7 days course of antibiotic treatment |
| 14 days course of antibiotic treatment | Active comparator | To assign the 14 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture Receives: Drug: 14 days course of antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate
Composite end point at 1 month after discontinuing antibiotics
Measured: 1 month
Secondary outcomes (3)
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate
Composite end point at 0.5 months after discontinuing antibiotics
Measured: 0.5 months
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and
Composite end point at 3 months after discontinuing antibiotics
Measured: 3 months
duration of hospital stay
duration of hospital stay
Measured: 30 days since randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pattraporn Ponglorpisit, MD, Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575495
- Sponsor's protocol ID
- EC_580278
- Status last verified
- Mar 2016
- First submitted
- 8 Oct 2015
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Control Study of Shortening Antibiotic Treatment Duration For Asymptomatic Bacteriuria Within A Month After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT02575495
- Acronym / sponsor ID
- EC_580278
- Conditions
- Kidney Transplantation, Bacteriuria, Asymptomatic Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 Oct 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 major hypothesis to be tested is that there was no difference in the clinical outcome between 7(short-course) and 14(traditional-course) days of antibiotic treatment for asymptomatic bacteriuria early after kidney transplantation.
Detailed description
Introduction: Treatment of asymptomatic bacteriuria is a common practice in renal transplant centers leading to prolong exposure of antimicrobial agents with long hospital length of stay. The duration of antibiotics treatment in this condition have never been proposed.
Objective: To evaluate the proper duration of antibiotic treatment for asymptomatic bacteriuria early (less than 1 month) after kidney transplantation
Method: This is a prospective, randomized, open labeled, single center study using intention to treat analysis. Patients will be identified and after informed consent is obtained, will be randomized to receive 7 or 14 days course of antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7 days course of antibiotic treatment | Experimental | Drug: 7 days course of antibiotic treatmentTo assign the 7 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture |
| 14 days course of antibiotic treatment | Active comparator | Drug: 14 days course of antibiotic treatmentTo assign the 14 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- First kidney transplantation
- Asymptomatic bacteriuria
Key exclusion criteria (7 listed)
- Refusal to participate in the study
- Re-transplantation or combined organ transplantation
- History of abnormal structure or function in native kidney, ureter and bladder system
- Kidney transplant recipients with history of recurrent urinary tract infection or incomplete course of urinary tract infection treatment before transplantation
- Hemodynamic unstable
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 |
|---|---|---|
| 7 days course of antibiotic treatmentAlso: short-course antibiotic treatmentstart specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 7 days | Drug | 7 days course of antibiotic treatment |
| 14 days course of antibiotic treatmentAlso: traditional-course antibiotic treatmentstart specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 14 days | Drug | 14 days course of antibiotic treatment |
Primary outcome
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate
Time frame: 1 month
Composite end point at 1 month after discontinuing antibiotics
3 secondary outcomes
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate
Time frame: 0.5 months
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and
Time frame: 3 months
duration of hospital stay
Time frame: 30 days since randomization
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 16 Mar 2016.
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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.
Pattraporn Ponglorpisit, MD principal investigator
Ramathibodi Hospital
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 7 days course of antibiotic treatment and 14 days course of antibiotic treatment in people with Kidney Transplantation and Bacteriuria, 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 2 inclusion and 7 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 16 Mar 2016. 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?
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?
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate (time frame: 1 month). 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 16 Mar 2016.