Peritoneal Dialysis Associated PeritonitisPhase 2/3NCT07113574
Pharmacokinetics of Meropenem and Aztreonam After Intraperitoneal Administration Via Cycler-therapy in APD Patients Without Peritonitis
A Phase 2/3 study testing Meropenem 1000 mg, Aztreonam 2000 mg and automated peritoneal dialysis with following long time dwell in people with Peritoneal Dialysis Associated Peritonitis and Peritoneal Dialysis (PD), run by Karl Landsteiner Insitute for Nephrology and Haemato-Oncology at 1 site in Austria.
Trial summary
Peritoneal dialysis-associated peritonitis (PDAP) remains one of the most serious complications in patients undergoing peritoneal dialysis (PD), contributing significantly to hospitalization, technique failure, and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis Associated Peritonitis, Peritoneal Dialysis (PD), Peritoneal Dialysis
- What is being tested?
- Meropenem 1000 mg, Aztreonam 2000 mg and automated peritoneal dialysis with following long time dwell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- 31 Aug 2021to 24 Jul 2022
- Phase
- Phase 2/3
- 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
- Male or female patients, aged over 18 years
- Patients on a stable APD regime for at least 1 month
- Patients on an APD regime using a glucose-based PDF (1,36% and/or 2,27%) for short nighttime dwells and Icodextrin for the long daytime dwell
- Willingness and ability to comply with the protocol
- Signed informed consent
Who cannot join
- Any systemic infection
- Peritonitis or catheter-related infection which required antibiotic treatment within 2 months prior to the start of the study
- Allergy or hypersensitivity against study drug
- Severe hepatic impairment (Child-Pugh Class C)
- Pregnancy, or women of childbearing potential not willing to apply adequate contraception during study period
- Any disease considered relevant for proper performance of the study or risks to the patient, at the discretion of the investigator
- Hemoglobin below 9 g/dl
- BMI below 19 or above 35
Trial locations and contacts
1 site in 1 country.
About this study
Peritoneal dialysis-associated peritonitis (PDAP) remains one of the most serious complications in patients undergoing peritoneal dialysis (PD), contributing significantly to hospitalization, technique failure, and mortality. Intraperitoneal (IP) antibiotic administration is the standard of care in PDAP, as it provides high local drug concentrations at the site of infection. However, dosing recommendations are largely based on pharmacokinetic (PK) studies in continuous ambulatory peritoneal dialysis (CAPD) patients. Automated peritoneal dialysis (APD), now widely used, differs significantly from CAPD in terms of dialysate volumes, frequency of exchanges, and peritoneal clearance. As a result, extrapolation of CAPD-based dosing regimens may lead to antibiotic underdosing in APD patients.
This prospective, open-label, single-center descriptive PK study investigates the plasma and dialysate concentration-time profiles of meropenem and aztreonam after IP administration into the short-dwell cycler exchanges during nighttime APD. The rationale is that administration into the early short dwells may ensure adequate antibiotic levels both during active cycling (when frequent exchanges may clear the drug rapidly) and during the subsequent long daytime dwell through back-diffusion from systemic circulation.
Read more
Twelve stable APD patients without peritonitis will be enrolled (6 per drug group). Inclusion requires patients to be on a stable APD regimen for at least one month using glucose-based dialysate for short nighttime dwells and Icodextrin for the daytime dwell. Patients with current infections, recent peritonitis, or significant comorbid conditions are excluded.
On the study day, each participant will receive either:
Meropenem: 0.75 g added to a 5L glucose-based peritoneal dialysis fluid (PDF) bag, or
Aztreonam: 2 g prepared similarly.
The antibiotic-containing 5L PDF bag is used as the first bag in the APD cycler session, followed by a second 5L antibiotic-free PDF bag, yielding a total of five 2L nighttime exchanges. After cycler therapy, a 1.5L Icodextrin fill is instilled for the long daytime dwell.
Sampling includes:
Venous blood: at 0 (pre-dose), 1, 2, 4.5, 6.5, 9, 10, 12, 16, and 24 hours.
Dialysate: inflow/outflow from each cycle and at defined intervals during the Icodextrin dwell (up to 24 hours).
Urine: 5 mL from a 24-hour collection in patients with residual renal function.
Drug concentrations in plasma, dialysate, and urine will be quantified using validated high-performance liquid chromatography (HPLC) techniques. Primary PK endpoints include area under the curve (AUC), maximum plasma concentration (Cmax), time to reach Cmax (Tmax), and half-life (t½) in each compartment. Secondary endpoints include ratios of AUC and Cmax across compartments, time above the minimal inhibitory concentration (T>MIC), and AUC0-24/MIC.
This study does not include formal hypothesis testing but aims to generate descriptive PK data to inform optimized dosing of meropenem and aztreonam for APD patients. Currently, there is a lack of pharmacokinetic data guiding IP antibiotic dosing specifically in APD. The study's findings may support more accurate and effective antibiotic administration protocols for PDAP and potentially for the treatment of other systemic infections (e.g., pneumonia) in this population.
The anticipated benefit is improved antimicrobial efficacy through better PK/PD target attainment while avoiding the need for intravenous therapy. The risk to participants is minimal, consisting primarily of standard procedures (blood draws, single-dose IP drug administration). Ethical approval has been obtained, and all participants will provide written informed consent. The study complies with Good Clinical Practice (GCP) and relevant regulatory and ethical standards, including the Declaration of Helsinki.
- Conditions
- Peritoneal Dialysis Associated Peritonitis, Peritoneal Dialysis (PD), Peritoneal Dialysis, Peritoneal Dialysis, Continuous Ambulatory, Meropenem, Aztreonam
- Being tested
- Meropenem 1000 mg, Aztreonam 2000 mg, automated peritoneal dialysis with following long time dwell, Sampling
- Keywords
- Pharmacokinetics, meropenem, aztreonam, intraperitoneal administration, automated cycler-therapy, APD patients, peritonitis
- Medical subject headings
- Kidney Failure, Chronic, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meropenem 1000 mgDrug
Administration of meropenem after intraperitoneal administration via cycler-therapy in APD patients without peritonitis
Aztreonam 2000 mgDrug
Administration of aztreonam after intraperitoneal administration via cycler-therapy in APD patients without peritonitis
automated peritoneal dialysis with following long time dwellOther
The cycler therapy, followed by a prolonged dwell, will be performed as outlined in the study protocol.
SamplingDiagnostic test
The sampling of blood, dialysate, and urine will be performed as outlined in the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| intraperitoneal meropenem via cycler-therapy in APD | Experimental | Intraperitoneal administration of meropenem via cycler-therapy in automated peritoneal dialysis patients without peritonitis Receives: Drug: Meropenem 1000 mg; Other: automated peritoneal dialysis with following long time dwell; Diagnostic Test: Sampling |
| intraperitoneal aztreonam via cycler-therapy in APD | Experimental | Intraperitoneal administration of aztreonam via cycler-therapy in automated peritoneal dialysis patients without peritonitis Receives: Drug: Aztreonam 2000 mg; Other: automated peritoneal dialysis with following long time dwell; Diagnostic Test: Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC)
Measured: 24 hours
Maximum concentration (Cmax)
Measured: 24 hours
Time to Cmax (Tmax)
Measured: 24 hours
Half-life (t½)
Measured: 24 hours
Secondary outcomes (3)
Time above minimum inhibitory concentration (T>MIC)
Measured: 24 hours
AUC0-24/MIC
Measured: 24 hours
Compartmental ratios (AUC, Cmax)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start31 Aug 2021
- Primary completion24 Jul 2022
- Study completion24 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Peritoneal Dialysis Associated PeritonitisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karl Landsteiner Insitute for Nephrology and Haemato-Oncology
- Sponsor type
- Research network
- Collaborators
- Karl Landsteiner University of Health Sciences, Medical University of Cologne, University Hospital St. Polten, University of Vienna
- Responsible party
- Principal investigator, Dominik Tüchler, Karl Landsteiner Insitute for Nephrology and Haemato-Oncology
- Investigators
- Martin F Wiesholzer, MD, Principal investigator, UK St. Pölten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113574
- Sponsor's protocol ID
- GS1-EK-2/483-2020
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
de Vin F, Rutherford P, Faict D. Intraperitoneal administration of drugs in peritoneal dialysis patients: a review of compatibility and guidance for clinical use. Perit Dial Int. 2009 Jan-Feb;29(1):5-15.
PubMed 19164246Kussmann M, Schuster L, Wrenger S, Pichler P, Reznicek G, Burgmann H, Poeppl W, Zeitlinger M, Wiesholzer M. Influence of Different Peritoneal Dialysis Fluids on the In Vitro Activity of Cefepime, Ciprofloxacin, Ertapenem, Meropenem and Tobramycin Against Escherichia Coli. Perit Dial Int. 2016 11-12;36(6):662-668. doi: 10.3747/pdi.2015.00161. Epub 2016 Sep 28.
PubMed 27680756Wiesholzer M, Pichler P, Reznicek G, Wimmer M, Kussmann M, Balcke P, Burgmann H, Zeitlinger M, Poeppl W. An Open, Randomized, Single-Center, Crossover Pharmacokinetic Study of Meropenem after Intraperitoneal and Intravenous Administration in Patients Receiving Automated Peritoneal Dialysis. Antimicrob Agents Chemother. 2016 Apr 22;60(5):2790-7. doi: 10.1128/AAC.02664-15. Print 2016 May.
PubMed 26902765Warady BA, Bakkaloglu S, Newland J, Cantwell M, Verrina E, Neu A, Chadha V, Yap HK, Schaefer F. Consensus guidelines for the prevention and treatment of catheter-related infections and peritonitis in pediatric patients receiving peritoneal dialysis: 2012 update. Perit Dial Int. 2012 Jun;32 Suppl 2(Suppl 2):S32-86. doi: 10.3747/pdi.2011.00091. No abstract available.
PubMed 22851742Peerapornratana S, Chariyavilaskul P, Kanjanabuch T, Praditpornsilpa K, Eiam-Ong S, Katavetin P. Short-Dwell Cycling Intraperitoneal Cefazolin Plus Ceftazidime in Peritoneal Dialysis Patients. Perit Dial Int. 2017 Mar-Apr;37(2):218-224. doi: 10.3747/pdi.2015.00300. Epub 2016 Oct 13.
PubMed 27738089Manley HJ, Bailie GR. Treatment of peritonitis in APD: pharmacokinetic principles. Semin Dial. 2002 Nov-Dec;15(6):418-21. doi: 10.1046/j.1525-139x.2002.00103.x.
PubMed 12437537Salzer W. Antimicrobial-resistant gram-positive bacteria in PD peritonitis and the newer antibiotics used to treat them. Perit Dial Int. 2005 Jul-Aug;25(4):313-9.
PubMed 16022084Van Ende C, Tintillier M, Cuvelier C, Migali G, Pochet JM. Intraperitoneal meropenem administration: a possible alternative to the intravenous route. Perit Dial Int. 2010 Mar-Apr;30(2):250-1. doi: 10.3747/pdi.2009.00052. No abstract available.
PubMed 20200373Li PK, Szeto CC, Piraino B, de Arteaga J, Fan S, Figueiredo AE, Fish DN, Goffin E, Kim YL, Salzer W, Struijk DG, Teitelbaum I, Johnson DW. ISPD Peritonitis Recommendations: 2016 Update on Prevention and Treatment. Perit Dial Int. 2016 Sep 10;36(5):481-508. doi: 10.3747/pdi.2016.00078. Epub 2016 Jun 9. No abstract available.
PubMed 27282851Hsieh YP, Chang CC, Wang SC, Wen YK, Chiu PF, Yang Y. Predictors for and impact of high peritonitis rate in Taiwanese continuous ambulatory peritoneal dialysis patients. Int Urol Nephrol. 2015 Jan;47(1):183-9. doi: 10.1007/s11255-014-0763-5. Epub 2014 Jul 18.
PubMed 25034275Szeto CC, Wong TY, Chow KM, Leung CB, Li PK. Are peritoneal dialysis patients with and without residual renal function equivalent for survival study? Insight from a retrospective review of the cause of death. Nephrol Dial Transplant. 2003 May;18(5):977-82. doi: 10.1093/ndt/gfg027.
PubMed 12686674Perez Fontan M, Rodriguez-Carmona A, Garcia-Naveiro R, Rosales M, Villaverde P, Valdes F. Peritonitis-related mortality in patients undergoing chronic peritoneal dialysis. Perit Dial Int. 2005 May-Jun;25(3):274-84.
PubMed 15981776Ghali JR, Bannister KM, Brown FG, Rosman JB, Wiggins KJ, Johnson DW, McDonald SP. Microbiology and outcomes of peritonitis in Australian peritoneal dialysis patients. Perit Dial Int. 2011 Nov-Dec;31(6):651-62. doi: 10.3747/pdi.2010.00131. Epub 2011 Jun 30.
PubMed 21719685Davenport A. Peritonitis remains the major clinical complication of peritoneal dialysis: the London, UK, peritonitis audit 2002-2003. Perit Dial Int. 2009 May-Jun;29(3):297-302.
PubMed 19458302Brown MC, Simpson K, Kerssens JJ, Mactier RA; Scottish Renal Registry. Peritoneal dialysis-associated peritonitis rates and outcomes in a national cohort are not improving in the post-millennium (2000-2007). Perit Dial Int. 2011 Nov-Dec;31(6):639-50. doi: 10.3747/pdi.2010.00185. Epub 2011 Jul 31.
PubMed 21804138
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Meropenem and Aztreonam After Intraperitoneal Administration Via Cycler-therapy in APD Patients Without Peritonitis
- ClinicalTrials.gov ID
- NCT07113574
- Acronym / sponsor ID
- GS1-EK-2/483-2020
- Conditions
- Peritoneal Dialysis Associated Peritonitis, Peritoneal Dialysis (PD), Peritoneal Dialysis, Peritoneal Dialysis, Continuous Ambulatory, Meropenem, Aztreonam
- Keywords
- Pharmacokinetics, meropenem, aztreonam, intraperitoneal administration, automated cycler-therapy, APD patients, peritonitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Karl Landsteiner Insitute for Nephrology and Haemato-OncologyResearch network
- Collaborators
- Karl Landsteiner University of Health Sciences, Medical University of Cologne, University Hospital St. Polten, University of Vienna
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 24 Jul 2022 (actual)
- Study completion
- 24 Jul 2022 (actual)
- First posted
- 11 Aug 2025 (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.
Peritoneal dialysis-associated peritonitis (PDAP) remains one of the most serious complications in patients undergoing peritoneal dialysis (PD), contributing significantly to hospitalization, technique failure, and mortality. Intraperitoneal (IP) antibiotic administration is the standard of care in PDAP, as it provides high local drug concentrations at the site of infection. However, dosing recommendations are largely based on pharmacokinetic (PK) studies in continuous ambulatory peritoneal dialysis (CAPD) patients. Automated peritoneal dialysis (APD), now widely used, differs significantly from CAPD in terms of dialysate volumes, frequency of exchanges, and peritoneal clearance. As a result, extrapolation of CAPD-based dosing regimens may lead to antibiotic underdosing in APD patients.
This prospective, open-label, single-center descriptive PK study investigates the plasma and dialysate concentration-time profiles of meropenem and aztreonam after IP administration into the short-dwell cycler exchanges during nighttime APD. The rationale is that administration into the early short dwells may ensure adequate antibiotic levels both during active cycling (when frequent exchanges may clear the drug rapidly) and during the subsequent long daytime dwell through back-diffusion from systemic circulation.
Twelve stable APD patients without peritonitis will be enrolled (6 per drug group). Inclusion requires patients to be on a stable APD regimen for at least one month using glucose-based dialysate for short nighttime dwells and Icodextrin for the daytime dwell. Patients with current infections, recent peritonitis, or significant comorbid conditions are excluded.
On the study day, each participant will receive either:
Meropenem: 0.75 g added to a 5L glucose-based peritoneal dialysis fluid (PDF) bag, or
Aztreonam: 2 g prepared similarly.
The antibiotic-containing 5L PDF bag is used as the first bag in the APD cycler session, followed by a second 5L antibiotic-free PDF bag, yielding a total of five 2L nighttime exchanges. After cycler therapy, a 1.5L Icodextrin fill is instilled for the long daytime dwell.
Sampling includes:
Venous blood: at 0 (pre-dose), 1, 2, 4.5, 6.5, 9, 10, 12, 16, and 24 hours.
Dialysate: inflow/outflow from each cycle and at defined intervals during the Icodextrin dwell (up to 24 hours).
Urine: 5 mL from a 24-hour collection in patients with residual renal function.
Drug concentrations in plasma, dialysate, and urine will be quantified using validated high-performance liquid chromatography (HPLC) techniques. Primary PK endpoints include area under the curve (AUC), maximum plasma concentration (Cmax), time to reach Cmax (Tmax), and half-life (t½) in each compartment. Secondary endpoints include ratios of AUC and Cmax across compartments, time above the minimal inhibitory concentration (T>MIC), and AUC0-24/MIC.
This study does not include formal hypothesis testing but aims to generate descriptive PK data to inform optimized dosing of meropenem and aztreonam for APD patients. Currently, there is a lack of pharmacokinetic data guiding IP antibiotic dosing specifically in APD. The study's findings may support more accurate and effective antibiotic administration protocols for PDAP and potentially for the treatment of other systemic infections (e.g., pneumonia) in this population.
The anticipated benefit is improved antimicrobial efficacy through better PK/PD target attainment while avoiding the need for intravenous therapy. The risk to participants is minimal, consisting primarily of standard procedures (blood draws, single-dose IP drug administration). Ethical approval has been obtained, and all participants will provide written informed consent. The study complies with Good Clinical Practice (GCP) and relevant regulatory and ethical standards, including the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intraperitoneal meropenem via cycler-therapy in APD | Experimental | Drug: Meropenem 1000 mg, Other: automated peritoneal dialysis with following long time dwell, Diagnostic Test: SamplingIntraperitoneal administration of meropenem via cycler-therapy in automated peritoneal dialysis patients without peritonitis |
| intraperitoneal aztreonam via cycler-therapy in APD | Experimental | Drug: Aztreonam 2000 mg, Other: automated peritoneal dialysis with following long time dwell, Diagnostic Test: SamplingIntraperitoneal administration of aztreonam via cycler-therapy in automated peritoneal dialysis patients without peritonitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients, aged over 18 years
- Patients on a stable APD regime for at least 1 month
- Patients on an APD regime using a glucose-based PDF (1,36% and/or 2,27%) for short nighttime dwells and Icodextrin for the long daytime dwell
- Willingness and ability to comply with the protocol
- Signed informed consent
Key exclusion criteria (8 listed)
- Any systemic infection
- Peritonitis or catheter-related infection which required antibiotic treatment within 2 months prior to the start of the study
- Allergy or hypersensitivity against study drug
- Severe hepatic impairment (Child-Pugh Class C)
- Pregnancy, or women of childbearing potential not willing to apply adequate contraception during 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 |
|---|---|---|
| Meropenem 1000 mgAdministration of meropenem after intraperitoneal administration via cycler-therapy in APD patients without peritonitis | Drug | intraperitoneal meropenem via cycler-therapy in APD |
| Aztreonam 2000 mgAdministration of aztreonam after intraperitoneal administration via cycler-therapy in APD patients without peritonitis | Drug | intraperitoneal aztreonam via cycler-therapy in APD |
| automated peritoneal dialysis with following long time dwellThe cycler therapy, followed by a prolonged dwell, will be performed as outlined in the study protocol. | Other | intraperitoneal aztreonam via cycler-therapy in APD, intraperitoneal meropenem via cycler-therapy in APD |
| SamplingThe sampling of blood, dialysate, and urine will be performed as outlined in the study protocol. | Diagnostic test | intraperitoneal aztreonam via cycler-therapy in APD, intraperitoneal meropenem via cycler-therapy in APD |
Primary outcome
Area Under the Curve (AUC)
Time frame: 24 hours
Maximum concentration (Cmax)
Time frame: 24 hours
Time to Cmax (Tmax)
Time frame: 24 hours
Half-life (t½)
Time frame: 24 hours
3 secondary outcomes
Time above minimum inhibitory concentration (T>MIC)
Time frame: 24 hours
AUC0-24/MIC
Time frame: 24 hours
Compartmental ratios (AUC, Cmax)
Time frame: 24 hours
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 11 Aug 2025.
- Background: PubMed 19164246de Vin F, Rutherford P, Faict D. Intraperitoneal administration of drugs in peritoneal dialysis patients: a review of compatibility and guidance for clinical use. Perit Dial Int. 2009 Jan-Feb;29(1):5-15.
- Background: PubMed 27680756Kussmann M, Schuster L, Wrenger S, Pichler P, Reznicek G, Burgmann H, Poeppl W, Zeitlinger M, Wiesholzer M. Influence of Different Peritoneal Dialysis Fluids on the In Vitro Activity of Cefepime, Ciprofloxacin, Ertapenem, Meropenem and Tobramycin Against Escherichia Coli. Perit Dial Int. 2016 11-12;36(6):662-668. doi: 10.3747/pdi.2015.00161. Epub 2016 Sep 28.
- Background: PubMed 26902765Wiesholzer M, Pichler P, Reznicek G, Wimmer M, Kussmann M, Balcke P, Burgmann H, Zeitlinger M, Poeppl W. An Open, Randomized, Single-Center, Crossover Pharmacokinetic Study of Meropenem after Intraperitoneal and Intravenous Administration in Patients Receiving Automated Peritoneal Dialysis. Antimicrob Agents Chemother. 2016 Apr 22;60(5):2790-7. doi: 10.1128/AAC.02664-15. Print 2016 May.
- Background: PubMed 22851742Warady BA, Bakkaloglu S, Newland J, Cantwell M, Verrina E, Neu A, Chadha V, Yap HK, Schaefer F. Consensus guidelines for the prevention and treatment of catheter-related infections and peritonitis in pediatric patients receiving peritoneal dialysis: 2012 update. Perit Dial Int. 2012 Jun;32 Suppl 2(Suppl 2):S32-86. doi: 10.3747/pdi.2011.00091. No abstract available.
- Background: PubMed 27738089Peerapornratana S, Chariyavilaskul P, Kanjanabuch T, Praditpornsilpa K, Eiam-Ong S, Katavetin P. Short-Dwell Cycling Intraperitoneal Cefazolin Plus Ceftazidime in Peritoneal Dialysis Patients. Perit Dial Int. 2017 Mar-Apr;37(2):218-224. doi: 10.3747/pdi.2015.00300. Epub 2016 Oct 13.
- Background: PubMed 12437537Manley HJ, Bailie GR. Treatment of peritonitis in APD: pharmacokinetic principles. Semin Dial. 2002 Nov-Dec;15(6):418-21. doi: 10.1046/j.1525-139x.2002.00103.x.
- Background: PubMed 16022084Salzer W. Antimicrobial-resistant gram-positive bacteria in PD peritonitis and the newer antibiotics used to treat them. Perit Dial Int. 2005 Jul-Aug;25(4):313-9.
- Background: PubMed 20200373Van Ende C, Tintillier M, Cuvelier C, Migali G, Pochet JM. Intraperitoneal meropenem administration: a possible alternative to the intravenous route. Perit Dial Int. 2010 Mar-Apr;30(2):250-1. doi: 10.3747/pdi.2009.00052. No abstract available.
- Background: PubMed 27282851Li PK, Szeto CC, Piraino B, de Arteaga J, Fan S, Figueiredo AE, Fish DN, Goffin E, Kim YL, Salzer W, Struijk DG, Teitelbaum I, Johnson DW. ISPD Peritonitis Recommendations: 2016 Update on Prevention and Treatment. Perit Dial Int. 2016 Sep 10;36(5):481-508. doi: 10.3747/pdi.2016.00078. Epub 2016 Jun 9. No abstract available.
- Background: PubMed 25034275Hsieh YP, Chang CC, Wang SC, Wen YK, Chiu PF, Yang Y. Predictors for and impact of high peritonitis rate in Taiwanese continuous ambulatory peritoneal dialysis patients. Int Urol Nephrol. 2015 Jan;47(1):183-9. doi: 10.1007/s11255-014-0763-5. Epub 2014 Jul 18.
- Background: PubMed 12686674Szeto CC, Wong TY, Chow KM, Leung CB, Li PK. Are peritoneal dialysis patients with and without residual renal function equivalent for survival study? Insight from a retrospective review of the cause of death. Nephrol Dial Transplant. 2003 May;18(5):977-82. doi: 10.1093/ndt/gfg027.
- Background: PubMed 15981776Perez Fontan M, Rodriguez-Carmona A, Garcia-Naveiro R, Rosales M, Villaverde P, Valdes F. Peritonitis-related mortality in patients undergoing chronic peritoneal dialysis. Perit Dial Int. 2005 May-Jun;25(3):274-84.
- Individual participant dataSharing planned: Yes
Related trials for Peritoneal Dialysis Associated Peritonitis
RecruitingObservational study
Peritoneal Dialysis Registration System (PERSIST)
ESRD, Disorders Associated With Peritoneal Dialysis
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.
Martin F Wiesholzer, MD principal investigator
UK St. Pölten
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Meropenem 1000 mg, Aztreonam 2000 mg and automated peritoneal dialysis with following long time dwell in people with Peritoneal Dialysis Associated Peritonitis and Peritoneal Dialysis (PD), run by Karl Landsteiner Insitute for Nephrology and Haemato-Oncology at 1 site in Austria.
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 5 inclusion and 8 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 11 Aug 2025. 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 Austria. 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 combined 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.
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?
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?
Area Under the Curve (AUC) (time frame: 24 hours). The study lists 4 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 NCT07113574, which also lists 16 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 11 Aug 2025.