Asymptomatic BacteriuriaNCT04333602
Asymptomatic Bacteriuria in Early Kidney Transplantation Follow up
A study testing Urinary culture and treatment if asymptomatic bacteriuria is detected in people with Asymptomatic Bacteriuria and Kidney Transplant Infection, run by Centenario Hospital Miguel Hidalgo at 1 site in Mexico.
Trial summary
Urinary tract infection (UTI) continues to be the leading cause of infection and hospitalization in post-kidney transplant (RT) surveillance. Facts such as immunosuppression, anatomical alterations and catheters are part of the factors that contribute to a high prevalence of this condition. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asymptomatic Bacteriuria, Kidney Transplant Infection
- What is being tested?
- Urinary culture and treatment if asymptomatic bacteriuria is detected
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2020to 16 Feb 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Kidney transplant candidates scheduled for the procedure
Who cannot join
- Patients with urological complications that did not have a bladder catheter and/or double J ureteral stent removed during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening and Treatment of Asymptomatic Bacteriuria in the First Two Months After Kidney Transplant. Randomized Control Trial
Urinary tract infection (UTI) continues to be the leading cause of infection and hospitalization in post-kidney transplant (RT) surveillance. Facts such as immunosuppression, anatomical alterations and catheters are part of the factors that contribute to a high prevalence of this condition. The incidence during the first trimester is highly variable and ranges between 15 and 50 %. This variability often depends on the definition of UTI, which sometimes overlaps with asymptomatic bacteriuria (AB). Currently the indication for treatment of AB is clear in pregnant patients and urological procedures. In post-RT surveillance, the treatment of AB is controversial. The use of Trimetropim Sulfamethoxazole during the first 6 months post RT is currently a recommendation, however new evidence has found the absence of benefit in the treatment of AB. Given the high prevalence of post RT AB and the increase in bacterial resistance, determining the usefulness of searching for and treating post RT AB is a priority in this population. Methodology: Randomized Controlled trial of kidney transplant candidates which will be randomized in the following groups: Group 1 (intervention) where the urine cultures will be analyzed openly, and in the case of asymptomatic bacteriuria, treatment based on the germ and antibiogram will be prescribed. Group 2 will undergo urine cultures at the same post-transplant times, the results will not be known by the clinical team and the participants will not receive treatment in the presence of present AB. Both groups, in the presence of UTI symptoms, will undergo urine culture and receive empirical treatment, which will be adjusted based on an antibiogram. The primary objective is to assess the prevalence of UTI, pyelonephritis, UTI-related hospitalizations, and antimicrobial resistance. As a secondary objective, the germs and associated virulence genes will be analyzed. Surveillance will be carried out for two months after transplantation and the predefined times for the evaluation of the BA will be: after the removal of the urinary catheter, week 3 and after the removal of the ureteral stent (month 2).
Read the detailed description
- Background Urinary tract infection (UTI) is the most frequent infectious complication in renal transplant recipients (RTR) during the first year, reaching an incidence from 23% to 75%. (1,2) Asymptomatic bacteriuria (AB) and UTI are associated with graft pyelonephritis, sepsis, acute rejection, and long-term graft dysfunction. (3-5) Recently, recurrent UTI episodes have been reported to be associated with poorer patient and graft survival compared to those without recurrent infection. (6) Risk factors are classified as: patient-related (diabetes mellitus, anatomical abnormalities of the urinary tract) and transplant-related (type of immunosuppression, time of the bladder catheter (UC) and double J stent. (7,8) The recommendations of the clinical guidelines suggest prophylaxis with trimethoprim / sulfamethoxazole (TMP / SMX) 160/800 mg every 24 hr during the first 6 months after kidney transplant (KT) ( 9).
The incidence of UTI in RTR has remained between 30 and 36% despite TMP / SMX antimicrobial prophylaxis (7) in a third-level care center in Mexico City; This high incidence is explained in part by the high resistance rate to TMP / SMX (> 80%) in clinical isolates of Escherichia coli recovered from urine both in Mexico and other regions of the world, a condition that discourages its continued use as a prophylactic agent from UTI. (10-12) Given this problem, a clinical trial of kidney transplant recipients was started, comparing the usual prophylaxis with TMP / SMX vs Phosphomycin 3 grams every 10 days for 6 months. The study was suspended prematurely due to therapeutic futility (19). A new clinical trial was performed using intravenous phosphomycin disodium the day of the transplant, prior to the removal of the bladder catheter and the double J ureteral stent. In this study, the intervention group presented a lower incidence of UTI (7.3 vs. 36.6%, p = 0.001).
In both previously described trials, patients underwent UTI screening by urine culture on specific days. Asymptomatic bacteriuria episodes are treated according to the susceptibility of the germ. This alone represents a strategy to decrease the incidence of UTI. Treatment of AB episodes has clearly not been shown to be beneficial in this group of patients. Recently in a controlled clinical trial no benefit was found in KTR with screening and treatment of AB after the second month of post KT. (14) This study partially supports the recommendations of clinical practice of the American Society of Infectious Diseases, where the systematic scrutiny and treatment of the UTI in kidney transplantation is mentioned as not recommended, however the authors propose possible benefit during the first month after KT. (2) II. Definition of the problem Urinary tract infection is the most frequent infectious complication after KT. The systematic screening and treatment of AB during the first months after transplantation is controversial. Given the increase in bacterial resistance, it is important to limit the exposure of antibiotics in high-risk groups. Various studies have demonstrated the utility of the administration of antimicrobial prophylaxis during the first months after transplantation for the reduction of UTI and AB events. However, these studies and several centers carry out systematic scrutiny of UTI with treatment of episodes of AB. Recently a controlled clinical trial showed that the scrutiny and treatment of AB after the second month after transplantation is not useful.
III. Justification UTI represents the most frequent cause of post kidney transplant infection. AB is highly prevalent during the first months after KT. Its prevalence during the first trimester is high and currently the treatment of AB is not fully justified. Due to the need to avoid the abuse of antibiotics in our setting, it is necessary to evaluate the usefulness of screening and treatment of AB in the first 8 weeks post KT. The Medical Center where the trial will be done, performs an average of 100 to 120 kidney transplants annually, which makes the clinical trial feasible.
IV. Hypothesis The screening and treatment of AB during the first 2 months will reduce the incidence of UTI, pyelonephritis and hospitalizations by 50% (composite outcome).
- Objectives. To assess the efficacy of AB screening and treatment in KT recipients during the first two months post KT.
To assess the incidence of UTI, pyelonephritis and hospitalizations associated with UTI Assess the prevalence of multi-resistant germs The urine culture samples will be labeled and in case of being positive, the isolated strain will be conserved for the subsequent identification of virulence genes. Said strain will be identified with the record of the study of the patient, in order to know the clinical variables of the time of obtaining said sample.
VIII. Definition of monitoring variables Asymptomatic Bacteriuria: In the case of men, medium stream urine culture with isolation of > 1 x 105 colonies. In the case of women, medium-stream urine culture with isolation of > 1 x 105 colonies (2 cultures), must be the same germ.
Urinary tract infection: Isolation of medium stream urine culture >1 x 104 colonies coupled with symptoms such as fever, dysuria, leukocyturia or positive nitrites. If it is only fever, another infectious focus should be ruled out.
Pyelonephritis: Urinary tract infection coupled with fever, graft pain, systemic inflammatory response, or shock. It should not have another concomitant infection.
- Sample Size:
Taking into account that UTI events occur on average 30% during the first 3 months after KT if the investigators want to reduce events to 10%. Taking the proportions formula. The sample required to be included is 62 patients per maneuver group.
- Being tested
- Urinary culture and treatment if asymptomatic bacteriuria is detected
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary culture and treatment if asymptomatic bacteriuria is detectedDiagnostic test
Also called Clinical decision based in the presence of asymptomatic bacteriuria
Urinary culture: post- bladder catheter removal, three weeks post-transplant and before double-J ureteral stent removal. Based in the assigned group If we detect asymptomatic bacteriuria specific treatment will be instituted or No treatment.
| Study group | Role | What they receive |
|---|---|---|
| Screening and Treatment of Asymptomatic Bacteriruria | Experimental | All patients assigned to this arm will be screen with urine culture: post- bladder catheter removal, three weeks post-transplant and before double-J ureteral stent removal. If we detect asymptomatic bacteriuria specific treatment will be instituted. Receives: Diagnostic Test: Urinary culture and treatment if asymptomatic bacteriuria is detected |
| Screening and NO treatment of Asymptomatic Bacteriuria | No intervention | All patients assigned to this arm will be screen with urine culture: post- bladder catheter removal, three weeks post-transplant and before double-J ureteral stent removal. No treatment will be instituted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic urinary tract infection
urinary symptoms associated with positive urine culture
Measured: Two months
Time to the first symptomatic urinary tract infection
urinary symptoms associated with positive urine culture
Measured: Two moths
Incidence of pyelonephritis or hospitalization related to urinary tract infection
Measured: Two months
Secondary outcomes (1)
Bacterial virulence genes related to urinary tract infection
- Coli and Klebsiella. sp virulence genes will be analysed
Measured: Two moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start1 Jan 2020
- Primary completion16 Feb 2022
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Asymptomatic BacteriuriaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Asymptomatic Bacteriuria screening and treatment and Group 2: Asymptomatic Bacteriuria screening and No treatment for AB.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centenario Hospital Miguel Hidalgo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Manuel Arreola Guerra, Centenario Hospital Miguel Hidalgo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333602
- Sponsor's protocol ID
- 2019-R-03
- Status last verified
- Feb 2022
- First submitted
- 1 Apr 2020
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee JR, Bang H, Dadhania D, Hartono C, Aull MJ, Satlin M, August P, Suthanthiran M, Muthukumar T. Independent risk factors for urinary tract infection and for subsequent bacteremia or acute cellular rejection: a single-center report of 1166 kidney allograft recipients. Transplantation. 2013 Oct 27;96(8):732-8. doi: 10.1097/TP.0b013e3182a04997.
PubMed 23917724Britt NS, Hagopian JC, Brennan DC, Pottebaum AA, Santos CAQ, Gharabagi A, Horwedel TA. Effects of recurrent urinary tract infections on graft and patient outcomes after kidney transplantation. Nephrol Dial Transplant. 2017 Oct 1;32(10):1758-1766. doi: 10.1093/ndt/gfx237.
PubMed 28967964Sorto R, Irizar SS, Delgadillo G, Alberu J, Correa-Rotter R, Morales-Buenrostro LE. Risk factors for urinary tract infections during the first year after kidney transplantation. Transplant Proc. 2010 Jan-Feb;42(1):280-1. doi: 10.1016/j.transproceed.2009.11.029.
PubMed 20172330de Souza RM, Olsburgh J. Urinary tract infection in the renal transplant patient. Nat Clin Pract Nephrol. 2008 May;4(5):252-64. doi: 10.1038/ncpneph0781. Epub 2008 Mar 11.
PubMed 18334970Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009 Nov;9 Suppl 3:S1-155. doi: 10.1111/j.1600-6143.2009.02834.x.
PubMed 19845597Kawecki D, Kwiatkowski A, Sawicka-Grzelak A, Durlik M, Paczek L, Chmura A, Mlynarczyk G, Rowinski W, Luczak M. Urinary tract infections in the early posttransplant period after kidney transplantation: etiologic agents and their susceptibility. Transplant Proc. 2011 Oct;43(8):2991-3. doi: 10.1016/j.transproceed.2011.09.002.
PubMed 21996207Origuen J, Fernandez-Ruiz M, Lopez-Medrano F, Ruiz-Merlo T, Gonzalez E, Morales JM, Fiorante S, San-Juan R, Villa J, Orellana MA, Andres A, Aguado JM. Progressive increase of resistance in Enterobacteriaceae urinary isolates from kidney transplant recipients over the past decade: narrowing of the therapeutic options. Transpl Infect Dis. 2016 Aug;18(4):575-84. doi: 10.1111/tid.12547. Epub 2016 Jul 4.
PubMed 27373698Falagas ME, Kastoris AC, Kapaskelis AM, Karageorgopoulos DE. Fosfomycin for the treatment of multidrug-resistant, including extended-spectrum beta-lactamase producing, Enterobacteriaceae infections: a systematic review. Lancet Infect Dis. 2010 Jan;10(1):43-50. doi: 10.1016/S1473-3099(09)70325-1.
PubMed 20129148Origuen J, Lopez-Medrano F, Fernandez-Ruiz M, Polanco N, Gutierrez E, Gonzalez E, Merida E, Ruiz-Merlo T, Morales-Cartagena A, Perez-Jacoiste Asin MA, Garcia-Reyne A, San Juan R, Orellana MA, Andres A, Aguado JM. Should Asymptomatic Bacteriuria Be Systematically Treated in Kidney Transplant Recipients? Results From a Randomized Controlled Trial. Am J Transplant. 2016 Oct;16(10):2943-2953. doi: 10.1111/ajt.13829. Epub 2016 May 23.
PubMed 27088545Nicolle LE, Bradley S, Colgan R, Rice JC, Schaeffer A, Hooton TM; Infectious Diseases Society of America; American Society of Nephrology; American Geriatric Society. Infectious Diseases Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in adults. Clin Infect Dis. 2005 Mar 1;40(5):643-54. doi: 10.1086/427507. Epub 2005 Feb 4. No abstract available.
PubMed 15714408Magiorakos AP, Srinivasan A, Carey RB, Carmeli Y, Falagas ME, Giske CG, Harbarth S, Hindler JF, Kahlmeter G, Olsson-Liljequist B, Paterson DL, Rice LB, Stelling J, Struelens MJ, Vatopoulos A, Weber JT, Monnet DL. Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance. Clin Microbiol Infect. 2012 Mar;18(3):268-81. doi: 10.1111/j.1469-0691.2011.03570.x. Epub 2011 Jul 27.
PubMed 21793988Bauer MP, Kuijper EJ, van Dissel JT; European Society of Clinical Microbiology and Infectious Diseases. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): treatment guidance document for Clostridium difficile infection (CDI). Clin Microbiol Infect. 2009 Dec;15(12):1067-79. doi: 10.1111/j.1469-0691.2009.03099.x.
PubMed 19929973Arreola-Guerra JM, Rosado-Canto R, Alberu J, Maravilla E, Torres-Gonzalez P, Criollo E, Perez M, Mancilla E, Arvizu M, Morales-Buenrostro LE, Vilatoba-Chapa M, Sifuentes-Osornio J. Fosfomycin trometamol in the prophylaxis of post-kidney transplant urinary tract infection: A controlled, randomized clinical trial. Transpl Infect Dis. 2018 Oct;20(5):e12980. doi: 10.1111/tid.12980. Epub 2018 Sep 10.
PubMed 30133928Alangaden GJ, Thyagarajan R, Gruber SA, Morawski K, Garnick J, El-Amm JM, West MS, Sillix DH, Chandrasekar PH, Haririan A. Infectious complications after kidney transplantation: current epidemiology and associated risk factors. Clin Transplant. 2006 Jul-Aug;20(4):401-9. doi: 10.1111/j.1399-0012.2006.00519.x.
PubMed 16842513Parasuraman R, Julian K; AST Infectious Diseases Community of Practice. Urinary tract infections in solid organ transplantation. Am J Transplant. 2013 Mar;13 Suppl 4:327-36. doi: 10.1111/ajt.12124. No abstract available.
PubMed 23465025
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Treatment of Asymptomatic Bacteriuria in the First Two Months After Kidney Transplant. Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04333602
- Acronym / sponsor ID
- 2019-R-03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centenario Hospital Miguel HidalgoUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 16 Feb 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 3 Apr 2020 (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.
Urinary tract infection (UTI) continues to be the leading cause of infection and hospitalization in post-kidney transplant (RT) surveillance. Facts such as immunosuppression, anatomical alterations and catheters are part of the factors that contribute to a high prevalence of this condition. The incidence during the first trimester is highly variable and ranges between 15 and 50 %. This variability often depends on the definition of UTI, which sometimes overlaps with asymptomatic bacteriuria (AB). Currently the indication for treatment of AB is clear in pregnant patients and urological procedures. In post-RT surveillance, the treatment of AB is controversial. The use of Trimetropim Sulfamethoxazole during the first 6 months post RT is currently a recommendation, however new evidence has found the absence of benefit in the treatment of AB. Given the high prevalence of post RT AB and the increase in bacterial resistance, determining the usefulness of searching for and treating post RT AB is a priority in this population. Methodology: Randomized Controlled trial of kidney transplant candidates which will be randomized in the following groups: Group 1 (intervention) where the urine cultures will be analyzed openly, and in the case of asymptomatic bacteriuria, treatment based on the germ and antibiogram will be prescribed. Group 2 will undergo urine cultures at the same post-transplant times, the results will not be known by the clinical team and the participants will not receive treatment in the presence of present AB. Both groups, in the presence of UTI symptoms, will undergo urine culture and receive empirical treatment, which will be adjusted based on an antibiogram. The primary objective is to assess the prevalence of UTI, pyelonephritis, UTI-related hospitalizations, and antimicrobial resistance. As a secondary objective, the germs and associated virulence genes will be analyzed. Surveillance will be carried out for two months after transplantation and the predefined times for the evaluation of the BA will be: after the removal of the urinary catheter, week 3 and after the removal of the ureteral stent (month 2).
Detailed description
- Background Urinary tract infection (UTI) is the most frequent infectious complication in renal transplant recipients (RTR) during the first year, reaching an incidence from 23% to 75%. (1,2) Asymptomatic bacteriuria (AB) and UTI are associated with graft pyelonephritis, sepsis, acute rejection, and long-term graft dysfunction. (3-5) Recently, recurrent UTI episodes have been reported to be associated with poorer patient and graft survival compared to those without recurrent infection. (6) Risk factors are classified as: patient-related (diabetes mellitus, anatomical abnormalities of the urinary tract) and transplant-related (type of immunosuppression, time of the bladder catheter (UC) and double J stent. (7,8) The recommendations of the clinical guidelines suggest prophylaxis with trimethoprim / sulfamethoxazole (TMP / SMX) 160/800 mg every 24 hr during the first 6 months after kidney transplant (KT) ( 9).
The incidence of UTI in RTR has remained between 30 and 36% despite TMP / SMX antimicrobial prophylaxis (7) in a third-level care center in Mexico City; This high incidence is explained in part by the high resistance rate to TMP / SMX (> 80%) in clinical isolates of Escherichia coli recovered from urine both in Mexico and other regions of the world, a condition that discourages its continued use as a prophylactic agent from UTI. (10-12) Given this problem, a clinical trial of kidney transplant recipients was started, comparing the usual prophylaxis with TMP / SMX vs Phosphomycin 3 grams every 10 days for 6 months. The study was suspended prematurely due to therapeutic futility (19). A new clinical trial was performed using intravenous phosphomycin disodium the day of the transplant, prior to the removal of the bladder catheter and the double J ureteral stent. In this study, the intervention group presented a lower incidence of UTI (7.3 vs. 36.6%, p = 0.001).
In both previously described trials, patients underwent UTI screening by urine culture on specific days. Asymptomatic bacteriuria episodes are treated according to the susceptibility of the germ. This alone represents a strategy to decrease the incidence of UTI. Treatment of AB episodes has clearly not been shown to be beneficial in this group of patients. Recently in a controlled clinical trial no benefit was found in KTR with screening and treatment of AB after the second month of post KT. (14) This study partially supports the recommendations of clinical practice of the American Society of Infectious Diseases, where the systematic scrutiny and treatment of the UTI in kidney transplantation is mentioned as not recommended, however the authors propose possible benefit during the first month after KT. (2) II. Definition of the problem Urinary tract infection is the most frequent infectious complication after KT. The systematic screening and treatment of AB during the first months after transplantation is controversial. Given the increase in bacterial resistance, it is important to limit the exposure of antibiotics in high-risk groups. Various studies have demonstrated the utility of the administration of antimicrobial prophylaxis during the first months after transplantation for the reduction of UTI and AB events. However, these studies and several centers carry out systematic scrutiny of UTI with treatment of episodes of AB. Recently a controlled clinical trial showed that the scrutiny and treatment of AB after the second month after transplantation is not useful.
III. Justification UTI represents the most frequent cause of post kidney transplant infection. AB is highly prevalent during the first months after KT. Its prevalence during the first trimester is high and currently the treatment of AB is not fully justified. Due to the need to avoid the abuse of antibiotics in our setting, it is necessary to evaluate the usefulness of screening and treatment of AB in the first 8 weeks post KT. The Medical Center where the trial will be done, performs an average of 100 to 120 kidney transplants annually, which makes the clinical trial feasible.
IV. Hypothesis The screening and treatment of AB during the first 2 months will reduce the incidence of UTI, pyelonephritis and hospitalizations by 50% (composite outcome).
- Objectives. To assess the efficacy of AB screening and treatment in KT recipients during the first two months post KT.
To assess the incidence of UTI, pyelonephritis and hospitalizations associated with UTI Assess the prevalence of multi-resistant germs The urine culture samples will be labeled and in case of being positive, the isolated strain will be conserved for the subsequent identification of virulence genes. Said strain will be identified with the record of the study of the patient, in order to know the clinical variables of the time of obtaining said sample.
VIII. Definition of monitoring variables Asymptomatic Bacteriuria: In the case of men, medium stream urine culture with isolation of > 1 x 105 colonies. In the case of women, medium-stream urine culture with isolation of > 1 x 105 colonies (2 cultures), must be the same germ.
Urinary tract infection: Isolation of medium stream urine culture >1 x 104 colonies coupled with symptoms such as fever, dysuria, leukocyturia or positive nitrites. If it is only fever, another infectious focus should be ruled out.
Pyelonephritis: Urinary tract infection coupled with fever, graft pain, systemic inflammatory response, or shock. It should not have another concomitant infection.
- Sample Size:
Taking into account that UTI events occur on average 30% during the first 3 months after KT if the investigators want to reduce events to 10%. Taking the proportions formula. The sample required to be included is 62 patients per maneuver group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1: Asymptomatic Bacteriuria screening and treatment and Group 2: Asymptomatic Bacteriuria screening and No treatment for AB.
| Arm | Type | Receives |
|---|---|---|
| Screening and Treatment of Asymptomatic Bacteriruria | Experimental | Diagnostic Test: Urinary culture and treatment if asymptomatic bacteriuria is detectedAll patients assigned to this arm will be screen with urine culture: post- bladder catheter removal, three weeks post-transplant and before double-J ureteral stent removal. If we detect asymptomatic bacteriuria specific treatment will be instituted. |
| Screening and NO treatment of Asymptomatic Bacteriuria | No intervention | –All patients assigned to this arm will be screen with urine culture: post- bladder catheter removal, three weeks post-transplant and before double-J ureteral stent removal. No treatment will be instituted. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Kidney transplant candidates scheduled for the procedure
Key exclusion criteria (1 listed)
- Patients with urological complications that did not have a bladder catheter and/or double J ureteral stent removed during the study period.
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 |
|---|---|---|
| Urinary culture and treatment if asymptomatic bacteriuria is detectedAlso: Clinical decision based in the presence of asymptomatic bacteriuriaUrinary culture: post- bladder catheter removal, three weeks post-transplant and before double-J ureteral stent removal. Based in the assigned group If we detect asymptomatic bacteriuria specific treatment will be instituted or No treatment. | Diagnostic test | Screening and Treatment of Asymptomatic Bacteriruria |
Primary outcome
Incidence of symptomatic urinary tract infection
Time frame: Two months
urinary symptoms associated with positive urine culture
Time to the first symptomatic urinary tract infection
Time frame: Two moths
urinary symptoms associated with positive urine culture
Incidence of pyelonephritis or hospitalization related to urinary tract infection
Time frame: Two months
1 secondary outcome
Bacterial virulence genes related to urinary tract infection
Time frame: Two moths
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 17 Feb 2022.
- Background: PubMed 23917724Lee JR, Bang H, Dadhania D, Hartono C, Aull MJ, Satlin M, August P, Suthanthiran M, Muthukumar T. Independent risk factors for urinary tract infection and for subsequent bacteremia or acute cellular rejection: a single-center report of 1166 kidney allograft recipients. Transplantation. 2013 Oct 27;96(8):732-8. doi: 10.1097/TP.0b013e3182a04997.
- Background: PubMed 28967964Britt NS, Hagopian JC, Brennan DC, Pottebaum AA, Santos CAQ, Gharabagi A, Horwedel TA. Effects of recurrent urinary tract infections on graft and patient outcomes after kidney transplantation. Nephrol Dial Transplant. 2017 Oct 1;32(10):1758-1766. doi: 10.1093/ndt/gfx237.
- Background: PubMed 20172330Sorto R, Irizar SS, Delgadillo G, Alberu J, Correa-Rotter R, Morales-Buenrostro LE. Risk factors for urinary tract infections during the first year after kidney transplantation. Transplant Proc. 2010 Jan-Feb;42(1):280-1. doi: 10.1016/j.transproceed.2009.11.029.
- Background: PubMed 18334970de Souza RM, Olsburgh J. Urinary tract infection in the renal transplant patient. Nat Clin Pract Nephrol. 2008 May;4(5):252-64. doi: 10.1038/ncpneph0781. Epub 2008 Mar 11.
- Background: PubMed 19845597Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009 Nov;9 Suppl 3:S1-155. doi: 10.1111/j.1600-6143.2009.02834.x.
- Background: PubMed 21996207Kawecki D, Kwiatkowski A, Sawicka-Grzelak A, Durlik M, Paczek L, Chmura A, Mlynarczyk G, Rowinski W, Luczak M. Urinary tract infections in the early posttransplant period after kidney transplantation: etiologic agents and their susceptibility. Transplant Proc. 2011 Oct;43(8):2991-3. doi: 10.1016/j.transproceed.2011.09.002.
- Background: PubMed 27373698Origuen J, Fernandez-Ruiz M, Lopez-Medrano F, Ruiz-Merlo T, Gonzalez E, Morales JM, Fiorante S, San-Juan R, Villa J, Orellana MA, Andres A, Aguado JM. Progressive increase of resistance in Enterobacteriaceae urinary isolates from kidney transplant recipients over the past decade: narrowing of the therapeutic options. Transpl Infect Dis. 2016 Aug;18(4):575-84. doi: 10.1111/tid.12547. Epub 2016 Jul 4.
- Background: PubMed 20129148Falagas ME, Kastoris AC, Kapaskelis AM, Karageorgopoulos DE. Fosfomycin for the treatment of multidrug-resistant, including extended-spectrum beta-lactamase producing, Enterobacteriaceae infections: a systematic review. Lancet Infect Dis. 2010 Jan;10(1):43-50. doi: 10.1016/S1473-3099(09)70325-1.
- Background: PubMed 27088545Origuen J, Lopez-Medrano F, Fernandez-Ruiz M, Polanco N, Gutierrez E, Gonzalez E, Merida E, Ruiz-Merlo T, Morales-Cartagena A, Perez-Jacoiste Asin MA, Garcia-Reyne A, San Juan R, Orellana MA, Andres A, Aguado JM. Should Asymptomatic Bacteriuria Be Systematically Treated in Kidney Transplant Recipients? Results From a Randomized Controlled Trial. Am J Transplant. 2016 Oct;16(10):2943-2953. doi: 10.1111/ajt.13829. Epub 2016 May 23.
- Background: PubMed 15714408Nicolle LE, Bradley S, Colgan R, Rice JC, Schaeffer A, Hooton TM; Infectious Diseases Society of America; American Society of Nephrology; American Geriatric Society. Infectious Diseases Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in adults. Clin Infect Dis. 2005 Mar 1;40(5):643-54. doi: 10.1086/427507. Epub 2005 Feb 4. No abstract available.
- Background: PubMed 21793988Magiorakos AP, Srinivasan A, Carey RB, Carmeli Y, Falagas ME, Giske CG, Harbarth S, Hindler JF, Kahlmeter G, Olsson-Liljequist B, Paterson DL, Rice LB, Stelling J, Struelens MJ, Vatopoulos A, Weber JT, Monnet DL. Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance. Clin Microbiol Infect. 2012 Mar;18(3):268-81. doi: 10.1111/j.1469-0691.2011.03570.x. Epub 2011 Jul 27.
- Background: PubMed 19929973Bauer MP, Kuijper EJ, van Dissel JT; European Society of Clinical Microbiology and Infectious Diseases. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): treatment guidance document for Clostridium difficile infection (CDI). Clin Microbiol Infect. 2009 Dec;15(12):1067-79. doi: 10.1111/j.1469-0691.2009.03099.x.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary culture and treatment if asymptomatic bacteriuria is detected in people with Asymptomatic Bacteriuria and Kidney Transplant Infection, run by Centenario Hospital Miguel Hidalgo at 1 site in Mexico.
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 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 17 Feb 2022. 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 Mexico. 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?
Incidence of symptomatic urinary tract infection (time frame: Two months). The study lists 3 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 NCT04333602, which also lists 17 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 17 Feb 2022.