Kidney Transplant InfectionPhase 3PREDICTNCT07407673
Prediction and Prevention of Bloodstream Infections After Kidney Transplantation
A Phase 3 study testing Pivmecillinam in people with Kidney Transplant Infection and Bloodstream Infection, run by Susanne Dam Nielsen, MD, DMSc at 3 sites in Denmark.
Trial summary
Kidney transplant recipients take medicines that suppress the immune system to prevent rejection of the transplanted kidney. As a result, they have a high risk of infections, especially urinary tract infections (UTIs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Infection, Bloodstream Infection, Kidney Transplant
- What is being tested?
- Pivmecillinam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Jan 2027to Jul 2041
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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.
- Kidney transplant recipient.
- Able to provide written informed consent.
- ≥1 urine sample with bacteriuria ≥10^5 CFU/mL (excluding fungi) within first month post-transplantation.
Who cannot join
- Known strictures in the esophagus and/or obstructions in the gastrointestinal tract including diabetes gastroparesis.
- Known hypersensitivity or allergy to β-lactam antibiotics.
- Known or suspected genetic metabolism anomalies in the carnitine metabolism, including carnitine transporter defect or organic acidurias such as methylmalonic aciduria or propionic acidaemia.
- Individuals of Faroese descent (defined as both biological parents born in the Faroe Islands).
- Porphyria.
- Current treatment with valproic acid, valproate or other medications liberating pivalic acid.
Show all 10Show fewer
- Current treatment with probenecid.
- Current treatment with methotrexate.
- Ongoing dialysis one month post-transplantation.
- Pregnancy or breastfeeding.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites
Aarhus University Hospital, Department of Nephrology
Aarhus, 8200
Henrik Birn, MD, PhD, dr.med., predict.rigshospitalet@regionh.dk
Henrik Birn, MD, PhD, dr.med.
Rigshospitalet, Department of Nephrology
Copenhagen, 2100
Susanne D Poulsen, MD, dr.med., 0045 3545 0859, predict.rigshospitalet@regionh.dk
Morten B Jørgensen, MD, PhD
Odense University Hospital, Department of Nephrology
Odense, 5000
Claus Bistrup, MD, Ph.d., predict.rigshospitalet@regionh.dk
Claus Bistrup, MD, PhD
About this study
Official title: Prediction and Prevention of Bloodstream Infections After Kidney Transplantation - The PREDICT Study
Kidney transplant recipients take medicines that suppress the immune system to prevent rejection of the transplanted kidney. As a result, they have a high risk of infections, especially urinary tract infections (UTIs). Some of these infections can spread to the bloodstream and cause serious illness, hospitalization, loss of kidney function, or death. Currently, there is no established strategy to prevent these serious bacterial infections in kidney transplant recipients who are at highest risk.
The PREDICT study is investigating whether a low daily dose of the antibiotic pivmecillinam can reduce the risk of bacterial urinary tract infections and bloodstream infections after kidney transplantation. The study includes kidney transplant recipients who have bacteria detected in their urine during the first month after transplantation, as previous research suggests that these patients have a particularly high risk of developing later serious infections.
Read more
In this randomized, double-blind, placebo-controlled trial, 180 adult kidney transplant recipients will be assigned by chance to receive either pivmecillinam or a matching placebo from 1 to 6 months after transplantation. Neither participants nor study staff will know which treatment has been assigned during the study. All participants will continue to receive standard post-transplant care and monitoring.
The main goal of the study is to determine whether prophylactic pivmecillinam can reduce the occurrence of infections caused by Enterobacterales bacteria, including urinary tract infections and bloodstream infections, during the first 6 months after transplantation. The study will also evaluate the effects of treatment on serious clinical outcomes, safety, quality of life, antimicrobial resistance, and long-term kidney transplant outcomes.
The main hypothesis is that targeted antibiotic prophylaxis with pivmecillinam in kidney transplant recipients at increased risk of infection will reduce the incidence of Enterobacterales urinary tract infections and bloodstream infections during the high-risk period after transplantation compared with placebo.
Read the detailed description
Background:
Kidney transplant recipients are at increased risk of infectious complications, in part because of immunosuppressive treatment required to prevent rejection of the transplanted kidney. Urinary tract infections are among the most common infectious complications after transplantation and may lead to bloodstream infections, which are associated with substantial morbidity, mortality, and risk of graft loss. Despite the burden of infections, there is currently no established targeted strategy to prevent serious bacterial infections in kidney transplant recipients.
Previous work by the investigators has demonstrated that bacteriuria during the first month after kidney transplantation is an important predictor of subsequent urinary tract infections and bloodstream infections. Early bacteriuria therefore represents a clinically useful marker for identifying a high-risk subgroup that may benefit from preventive interventions.
Study rationale:
The PREDICT study evaluates a risk-stratified prophylactic strategy using pivmecillinam in kidney transplant recipients with early bacteriuria. Pivmecillinam is a narrow-spectrum oral antibiotic with activity against Enterobacterales, which are the predominant causes of urinary tract infections and bloodstream infections after kidney transplantation. Its pharmacological profile and extensive clinical experience make it a suitable candidate for targeted prevention during the period of highest infection risk after transplantation.
Objectives:
The primary objective is to determine whether prophylactic pivmecillinam reduces the incidence of Enterobacterales urinary tract infections and/or bloodstream infections in high-risk kidney transplant recipients.
Secondary objectives include evaluation of all bloodstream and urinary tract infections, severe clinical outcomes, treatment safety, infections with multidrug-resistant organisms or Clostridioides difficile, and patient-reported quality of life.
Exploratory objectives include investigation of the distribution of urine antimicrobial susceptibility profiles, changes in the gut and urinary microbiome and resistome, changes in immunological and metabolic biomarkers, and long-term transplant outcomes.
Study Design:
PREDICT is a Danish nationwide multicentre randomized, double-blind, placebo-controlled trial. Adult kidney transplant recipients with bacteriuria during the first month after transplantation will be randomly assigned to receive prophylactic pivmecillinam or placebo in addition to standard post-transplant care. Participants will be followed during the intervention period and for safety evaluation after treatment completion. Ten-year long-term outcomes will be assessed through national registry follow-up.
- Conditions
- Kidney Transplant Infection, Bloodstream Infection, Kidney Transplant, Kidney Transplant Recipients, Infection, Urinary Tract Infection(UTI)
- Being tested
- Pivmecillinam, Placebo
- Keywords
- kidney transplantation, bloodstream infection, urinary tract infection, antibiotic prophylaxis, pivmecillinam, bacteriuria, Enterobacterales
- Medical subject headings
- Sepsis, Infections, Urinary Tract Infections, Bacteriuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PivmecillinamDrug
Study participants in the intervention arm will receive 400 mg pivmecillinam tablets once daily administered orally. Treatment will be initiated one month post-transplantation and will continue for a total duration of 5 months (months 1-6 post-transplantation).
PlaceboDrug
Study participants in the placebo arm will receive one inactive placebo tablet once daily; the timing, frequency and duration is the same as for the active study drug.
| Study group | Role | What they receive |
|---|---|---|
| Pivmecillinam | Active comparator | The intervention group (n = 90) will receive pivmecillinam 400 mg once daily from months 1-6 post-transplantation Receives: Drug: Pivmecillinam |
| Placebo | Placebo comparator | The placebo group (n = 90) will receive inactive placebo once daily from months 1-6 post-transplantation. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enterobacterales Urinary Tract Infections and/or Enterobacterales Bloodstream Infections
Cumulative incidence of participants experiencing at least one Enterobacterales urinary tract infection and/or Enterobacterales bloodstream infection during months 1-6 post-transplantation, i.e., composite endpoint
Measured: Months 1-6 post-transplantation
Secondary outcomes (15)
Time to Enterobacterales Bloodstream Infection
Time to first occurrence of Enterobacterales bloodstream infection during months 1-6 post-transplantation
Measured: Months 1-6 post-transplantation
Time to All-Cause Mortality
Time to death of any cause during months 1-6 post-transplantation
Measured: Months 1-6 post-transplantation
Time to First Hospital Admission
Time to first hospital admission during months 1-6 post-transplantation
Measured: Months 1-6 post-transplantation
Time to Graft Loss
Time to graft loss during months 1-6 post-transplantation
Measured: Months 1-6 post-transplantation
Time to ≥50% Decrease in eGFR From Baseline
Time to first occurence of a ≥50% decrease in eGFR from baseline during months 1-6 post-transplantation
Measured: Months 1-6 post-transplantation
Time to Severe Clinical Outcome
Time to first occurrence of severe clinical outcome during months 1-6 post-transplantation, i.e., composite endpoint of time to first Enterobacterales bloodstream infection, to death of any cause, to first hospital admission, to graft loss, or to first occurence of a ≥50% decrease in eGFR from baseline
Measured: Months 1-6 post-transplantation
Proportion of Participants with Severe Clinical Outcome
Proportion of participants with severe clinical outcome during months 1-6 post-transplantation, i.e., composite endpoint of Enterobacterales bloodstream infection, death of any cause, hospital admission, graft loss, ≥50% decrease in eGFR from baseline
Measured: Months 1-6 post-transplantation
Number of Enterobacterales Urinary Tract Infections
Number of Enterobacterales urinary tract infections during months 1-6 post-transplantation
Measured: Months 1-6 post-transplantation
Number of All Urinary Tract Infections
Number of all urinary tract infections during months 1-6 post-transplantation
Measured: Months 1-6 post-transplantation
Number of All Bloodstream Infections
Number of all bloodstream infections during months 1-6 post-transplantation
Measured: Months 1-6 post-transplantation
Participants Experiencing at Least One Serious Adverse Event and/or Adverse Event of Interest
Proportion of participants experiencing at least one serious adverse event and/or at least one adverse event of interest during months 1-6 post-transplantation.
Measured: Months 1-6 post-transplantation
Participants Experiencing at Least One Multidrug-Resistant Organism Infection
Proportion of participants experiencing at least one multidrug-resistant organism infection during months 1-6 post-transplantation
Measured: Months 1-6 post-transplantation
Number of Multidrug-Resistant Organism Infections
Number of multidrug-resistant organism infections during months 1-6 post-transplantation
Measured: Months 1-6 post-transplantation
Participants Experiencing at Least One Clostridioides difficile Infection
Proportion of participants experiencing at least one Clostridioides difficile infection during months 1-6 post-transplantation
Measured: Months 1-6 post-transplantation
Patient-reported quality of life
Patient-reported quality of life assessed 6 months post-transplantation using the Quality of Life Instrument for Solid Organ Transplant Recipients (OTSWI; Forsberg et al., 2012). Total scores range from 0 to 160, with lower scores indicating better quality of life
Measured: Months 1-6 post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Jan 2027 (estimated)
- Primary completionJul 2031 (estimated)
- Study completionJul 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Susanne Dam Nielsen, MD, DMSc
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital, Zealand University Hospital, Aalborg University Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Susanne Dam Nielsen, MD, DMSc, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407673
- Sponsor's protocol ID
- PREDICT, EU 2026-527337-63-00
- Other IDs
- 2026-527337-63-00
- Acronym
- PREDICT
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gondos A, Dohler B, Brenner H, Opelz G. Kidney graft survival in Europe and the United States: strikingly different long-term outcomes. Transplantation. 2013 Jan 27;95(2):267-74. doi: 10.1097/TP.0b013e3182708ea8.
PubMed 23060279Rasmussen DB, Moller DL, Hamm SR, Borges AH, Nielsen ACY, Kirkby NS, Sorensen SS, Nielsen SD. BKPyV DNAemia in Kidney Transplant Recipients Undergoing Regular Screening: A Single-Centre Cohort Study. Microorganisms. 2023 Dec 29;12(1):65. doi: 10.3390/microorganisms12010065.
PubMed 38257892Forsberg A, Persson LO, Nilsson M, Lennerling A. The organ transplant symptom and well-being instrument - psychometric evaluation. Open Nurs J. 2012;6:30-40. doi: 10.2174/1874434601206010030. Epub 2012 Apr 2.
PubMed 22523527Pinart M, Kranz J, Jensen K, Proctor T, Naber K, Kunath F, Wagenlehner F, Schmidt S. Optimal dosage and duration of pivmecillinam treatment for uncomplicated lower urinary tract infections: a systematic review and meta-analysis. Int J Infect Dis. 2017 May;58:96-109. doi: 10.1016/j.ijid.2017.03.012. Epub 2017 Mar 21.
PubMed 28341436Kim DK, Kim JH, Lee JY, Ku NS, Lee HS, Park JY, Kim JW, Kim KJ, Cho KS. Reappraisal of the treatment duration of antibiotic regimens for acute uncomplicated cystitis in adult women: a systematic review and network meta-analysis of 61 randomised clinical trials. Lancet Infect Dis. 2020 Sep;20(9):1080-1088. doi: 10.1016/S1473-3099(20)30121-3. Epub 2020 May 21.
PubMed 32446327Gupta K, Hooton TM, Naber KG, Wullt B, Colgan R, Miller LG, Moran GJ, Nicolle LE, Raz R, Schaeffer AJ, Soper DE; Infectious Diseases Society of America; European Society for Microbiology and Infectious Diseases. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: A 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011 Mar 1;52(5):e103-20. doi: 10.1093/cid/ciq257.
PubMed 21292654Kranz J, Bartoletti R, Bruyere F, Cai T, Geerlings S, Koves B, Schubert S, Pilatz A, Veeratterapillay R, Wagenlehner FME, Bausch K, Devlies W, Horvath J, Leitner L, Mantica G, Mezei T, Smith EJ, Bonkat G. European Association of Urology Guidelines on Urological Infections: Summary of the 2024 Guidelines. Eur Urol. 2024 Jul;86(1):27-41. doi: 10.1016/j.eururo.2024.03.035. Epub 2024 May 6.
PubMed 38714379Kaye KS, Santerre Henriksen A, Sommer M, Frimodt-Moller N. Safety and Tolerability of Pivmecillinam During More Than Four Decades of Clinical Experience: A Systematic Review. Clin Infect Dis. 2025 Feb 24;80(2):280-299. doi: 10.1093/cid/ciae621.
PubMed 39835818Frimodt-Moller N, Hertz FB. Pivmecillinam: past, present, and future. Expert Opin Pharmacother. 2026 Jun;27(8):669-676. doi: 10.1080/14656566.2026.2672731. Epub 2026 May 18.
PubMed 42130306Lodise TP, Kaye KS, Santerre Henriksen A, Kahlmeter G. Review of the In Vitro Microbiological Activity of Mecillinam Against Common Uropathogens in Uncomplicated Urinary Tract Infection: Focus on Resistant Pathogens. Open Forum Infect Dis. 2024 May 24;11(6):ofae296. doi: 10.1093/ofid/ofae296. eCollection 2024 Jun.
PubMed 38868308Hawkins BK, Ding H, Harriott MM, Wang JL. New Perspectives on Antimicrobial Agents: Pivmecillinam. Antimicrob Agents Chemother. 2025 Aug 6;69(8):e0182424. doi: 10.1128/aac.01824-24. Epub 2025 Jul 21.
PubMed 40689785Fox BC, Sollinger HW, Belzer FO, Maki DG. A prospective, randomized, double-blind study of trimethoprim-sulfamethoxazole for prophylaxis of infection in renal transplantation: clinical efficacy, absorption of trimethoprim-sulfamethoxazole, effects on the microflora, and the cost-benefit of prophylaxis. Am J Med. 1990 Sep;89(3):255-74. doi: 10.1016/0002-9343(90)90337-d.
PubMed 2118307Tolkoff-Rubin NE, Cosimi AB, Russell PS, Rubin RH. A controlled study of trimethoprim-sulfamethoxazole prophylaxis of urinary tract infection in renal transplant recipients. Rev Infect Dis. 1982 Mar-Apr;4(2):614-8. doi: 10.1093/clinids/4.2.614.
PubMed 7051249Green H, Rahamimov R, Gafter U, Leibovitci L, Paul M. Antibiotic prophylaxis for urinary tract infections in renal transplant recipients: a systematic review and meta-analysis. Transpl Infect Dis. 2011 Oct;13(5):441-7. doi: 10.1111/j.1399-3062.2011.00644.x. Epub 2011 Apr 26.
PubMed 21521435Rodriguez-Ramirez S, Hall V, Husain S, Kumar D, Kim SJ. Asymptomatic Bacteriuria in Kidney Transplant: Approaches to Screening and Treatment-A National Survey of Canadian Nephrologists. Clin Transplant. 2026 Apr;40(4):e70529. doi: 10.1111/ctr.70529.
PubMed 41930786
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Prevention of Bloodstream Infections After Kidney Transplantation - The PREDICT Study
- ClinicalTrials.gov ID
- NCT07407673
- Acronym / sponsor ID
- PREDICT / PREDICT, EU 2026-527337-63-00
- Conditions
- Kidney Transplant Infection, Bloodstream Infection, Kidney Transplant, Kidney Transplant Recipients, Infection, Urinary Tract Infection(UTI)
- Keywords
- kidney transplantation, bloodstream infection, urinary tract infection, antibiotic prophylaxis, pivmecillinam, bacteriuria, Enterobacterales
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Susanne Dam Nielsen, MD, DMScUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital, Zealand University Hospital, Aalborg University Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- Jul 2031 (estimated)
- Study completion
- Jul 2041 (estimated)
- First posted
- 12 Feb 2026 (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.
Kidney transplant recipients take medicines that suppress the immune system to prevent rejection of the transplanted kidney. As a result, they have a high risk of infections, especially urinary tract infections (UTIs). Some of these infections can spread to the bloodstream and cause serious illness, hospitalization, loss of kidney function, or death. Currently, there is no established strategy to prevent these serious bacterial infections in kidney transplant recipients who are at highest risk.
The PREDICT study is investigating whether a low daily dose of the antibiotic pivmecillinam can reduce the risk of bacterial urinary tract infections and bloodstream infections after kidney transplantation. The study includes kidney transplant recipients who have bacteria detected in their urine during the first month after transplantation, as previous research suggests that these patients have a particularly high risk of developing later serious infections.
In this randomized, double-blind, placebo-controlled trial, 180 adult kidney transplant recipients will be assigned by chance to receive either pivmecillinam or a matching placebo from 1 to 6 months after transplantation. Neither participants nor study staff will know which treatment has been assigned during the study. All participants will continue to receive standard post-transplant care and monitoring.
The main goal of the study is to determine whether prophylactic pivmecillinam can reduce the occurrence of infections caused by Enterobacterales bacteria, including urinary tract infections and bloodstream infections, during the first 6 months after transplantation. The study will also evaluate the effects of treatment on serious clinical outcomes, safety, quality of life, antimicrobial resistance, and long-term kidney transplant outcomes.
The main hypothesis is that targeted antibiotic prophylaxis with pivmecillinam in kidney transplant recipients at increased risk of infection will reduce the incidence of Enterobacterales urinary tract infections and bloodstream infections during the high-risk period after transplantation compared with placebo.
Detailed description
Background:
Kidney transplant recipients are at increased risk of infectious complications, in part because of immunosuppressive treatment required to prevent rejection of the transplanted kidney. Urinary tract infections are among the most common infectious complications after transplantation and may lead to bloodstream infections, which are associated with substantial morbidity, mortality, and risk of graft loss. Despite the burden of infections, there is currently no established targeted strategy to prevent serious bacterial infections in kidney transplant recipients.
Previous work by the investigators has demonstrated that bacteriuria during the first month after kidney transplantation is an important predictor of subsequent urinary tract infections and bloodstream infections. Early bacteriuria therefore represents a clinically useful marker for identifying a high-risk subgroup that may benefit from preventive interventions.
Study rationale:
The PREDICT study evaluates a risk-stratified prophylactic strategy using pivmecillinam in kidney transplant recipients with early bacteriuria. Pivmecillinam is a narrow-spectrum oral antibiotic with activity against Enterobacterales, which are the predominant causes of urinary tract infections and bloodstream infections after kidney transplantation. Its pharmacological profile and extensive clinical experience make it a suitable candidate for targeted prevention during the period of highest infection risk after transplantation.
Objectives:
The primary objective is to determine whether prophylactic pivmecillinam reduces the incidence of Enterobacterales urinary tract infections and/or bloodstream infections in high-risk kidney transplant recipients.
Secondary objectives include evaluation of all bloodstream and urinary tract infections, severe clinical outcomes, treatment safety, infections with multidrug-resistant organisms or Clostridioides difficile, and patient-reported quality of life.
Exploratory objectives include investigation of the distribution of urine antimicrobial susceptibility profiles, changes in the gut and urinary microbiome and resistome, changes in immunological and metabolic biomarkers, and long-term transplant outcomes.
Study Design:
PREDICT is a Danish nationwide multicentre randomized, double-blind, placebo-controlled trial. Adult kidney transplant recipients with bacteriuria during the first month after transplantation will be randomly assigned to receive prophylactic pivmecillinam or placebo in addition to standard post-transplant care. Participants will be followed during the intervention period and for safety evaluation after treatment completion. Ten-year long-term outcomes will be assessed through national registry follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pivmecillinam | Active comparator | Drug: PivmecillinamThe intervention group (n = 90) will receive pivmecillinam 400 mg once daily from months 1-6 post-transplantation |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo group (n = 90) will receive inactive placebo once daily from months 1-6 post-transplantation. |
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.
- Kidney transplant recipient.
- Able to provide written informed consent.
- ≥1 urine sample with bacteriuria ≥10^5 CFU/mL (excluding fungi) within first month post-transplantation.
Key exclusion criteria (10 listed)
- Known strictures in the esophagus and/or obstructions in the gastrointestinal tract including diabetes gastroparesis.
- Known hypersensitivity or allergy to β-lactam antibiotics.
- Known or suspected genetic metabolism anomalies in the carnitine metabolism, including carnitine transporter defect or organic acidurias such as methylmalonic aciduria or propionic acidaemia.
- Individuals of Faroese descent (defined as both biological parents born in the Faroe Islands).
- Porphyria.
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 |
|---|---|---|
| PivmecillinamStudy participants in the intervention arm will receive 400 mg pivmecillinam tablets once daily administered orally. Treatment will be initiated one month post-transplantation and will continue for a total duration of 5 months (months 1-6 post-transplantation). | Drug | Pivmecillinam |
| PlaceboStudy participants in the placebo arm will receive one inactive placebo tablet once daily; the timing, frequency and duration is the same as for the active study drug. | Drug | Placebo |
Primary outcome
Enterobacterales Urinary Tract Infections and/or Enterobacterales Bloodstream Infections
Time frame: Months 1-6 post-transplantation
Cumulative incidence of participants experiencing at least one Enterobacterales urinary tract infection and/or Enterobacterales bloodstream infection during months 1-6 post-transplantation, i.e., composite endpoint
15 secondary outcomes
Time to Enterobacterales Bloodstream Infection
Time frame: Months 1-6 post-transplantation
Time to All-Cause Mortality
Time frame: Months 1-6 post-transplantation
Time to First Hospital Admission
Time frame: Months 1-6 post-transplantation
Time to Graft Loss
Time frame: Months 1-6 post-transplantation
Time to ≥50% Decrease in eGFR From Baseline
Time frame: Months 1-6 post-transplantation
Time to Severe Clinical Outcome
Time frame: Months 1-6 post-transplantation
Proportion of Participants with Severe Clinical Outcome
Time frame: Months 1-6 post-transplantation
Number of Enterobacterales Urinary Tract Infections
Time frame: Months 1-6 post-transplantation
Number of All Urinary Tract Infections
Time frame: Months 1-6 post-transplantation
Number of All Bloodstream Infections
Time frame: Months 1-6 post-transplantation
Participants Experiencing at Least One Serious Adverse Event and/or Adverse Event of Interest
Time frame: Months 1-6 post-transplantation
Participants Experiencing at Least One Multidrug-Resistant Organism Infection
Time frame: Months 1-6 post-transplantation
Number of Multidrug-Resistant Organism Infections
Time frame: Months 1-6 post-transplantation
Participants Experiencing at Least One Clostridioides difficile Infection
Time frame: Months 1-6 post-transplantation
Patient-reported quality of life
Time frame: Months 1-6 post-transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 23060279Gondos A, Dohler B, Brenner H, Opelz G. Kidney graft survival in Europe and the United States: strikingly different long-term outcomes. Transplantation. 2013 Jan 27;95(2):267-74. doi: 10.1097/TP.0b013e3182708ea8.
- Background: PubMed 38257892Rasmussen DB, Moller DL, Hamm SR, Borges AH, Nielsen ACY, Kirkby NS, Sorensen SS, Nielsen SD. BKPyV DNAemia in Kidney Transplant Recipients Undergoing Regular Screening: A Single-Centre Cohort Study. Microorganisms. 2023 Dec 29;12(1):65. doi: 10.3390/microorganisms12010065.
- Background: PubMed 22523527Forsberg A, Persson LO, Nilsson M, Lennerling A. The organ transplant symptom and well-being instrument - psychometric evaluation. Open Nurs J. 2012;6:30-40. doi: 10.2174/1874434601206010030. Epub 2012 Apr 2.
- Background: PubMed 28341436Pinart M, Kranz J, Jensen K, Proctor T, Naber K, Kunath F, Wagenlehner F, Schmidt S. Optimal dosage and duration of pivmecillinam treatment for uncomplicated lower urinary tract infections: a systematic review and meta-analysis. Int J Infect Dis. 2017 May;58:96-109. doi: 10.1016/j.ijid.2017.03.012. Epub 2017 Mar 21.
- Background: PubMed 32446327Kim DK, Kim JH, Lee JY, Ku NS, Lee HS, Park JY, Kim JW, Kim KJ, Cho KS. Reappraisal of the treatment duration of antibiotic regimens for acute uncomplicated cystitis in adult women: a systematic review and network meta-analysis of 61 randomised clinical trials. Lancet Infect Dis. 2020 Sep;20(9):1080-1088. doi: 10.1016/S1473-3099(20)30121-3. Epub 2020 May 21.
- Background: PubMed 21292654Gupta K, Hooton TM, Naber KG, Wullt B, Colgan R, Miller LG, Moran GJ, Nicolle LE, Raz R, Schaeffer AJ, Soper DE; Infectious Diseases Society of America; European Society for Microbiology and Infectious Diseases. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: A 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011 Mar 1;52(5):e103-20. doi: 10.1093/cid/ciq257.
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- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pivmecillinam in people with Kidney Transplant Infection and Bloodstream Infection, run by Susanne Dam Nielsen, MD, DMSc at 3 sites in Denmark.
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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanne D Poulsen, MD, dr.med. (0045 3545 0859, susanne.dam.poulsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enterobacterales Urinary Tract Infections and/or Enterobacterales Bloodstream Infections (time frame: Months 1-6 post-transplantation). 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 NCT07407673, which also lists 28 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 16 Oct 2026.