Peritoneal Dialysis-associated PeritonitisPhase 2/3NCT07113587
Pharmacokinetics of Intraperitoneal and Intravenous Meropenem, Ampicillin, Aztreonam and Ciprofloxacin in Automated Peritoneal Dialysis Patients Without Peritonitis
A Phase 2/3 study testing Application of intraperitoneal and intravenous meropenem in in automated peritoneal dialysis patients without peritonitis, Application of intraperitoneal and intravenous ampicillin in automated peritoneal dialysis patients without peritonitis and Application of intraperitoneal and intravenous aztreonam in automated peritoneal dialysis patients without peritonitis 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
This study aims to investigate the pharmacokinetics (PK) and pharmacodynamic (PD) profiles of four commonly used antibiotics - meropenem, ampicillin, aztreonam, and ciprofloxacin - administered via intravenous (i.v.) and intraperitoneal (i.p.) routes in patients undergoing automated peritoneal dialysis (APD) without… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peritoneal Dialysis-associated Peritonitis, Peritoneal Dialysis (PD), Pharmacokinetics
- What is being tested?
- Application of intraperitoneal and intravenous meropenem in in automated peritoneal dialysis patients without peritonitis, Application of intraperitoneal and intravenous ampicillin in automated peritoneal dialysis patients without peritonitis and Application of intraperitoneal and intravenous aztreonam in automated peritoneal dialysis patients without peritonitis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- 8 Apr 2014to 7 Jul 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-85 on APD using icodextrin.
- Informed consent provided.
- No recent infections or antibiotic use.
Who cannot join
- Active systemic infection or recent peritonitis.
- Severe liver disease, pregnancy, allergy to study drugs.
- Hemoglobin <9 g/dL; BMI <19 or >35.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the pharmacokinetics (PK) and pharmacodynamic (PD) profiles of four commonly used antibiotics - meropenem, ampicillin, aztreonam, and ciprofloxacin - administered via intravenous (i.v.) and intraperitoneal (i.p.) routes in patients undergoing automated peritoneal dialysis (APD) without peritonitis. Existing dosing regimens for APD patients are often extrapolated from continuous ambulatory peritoneal dialysis (CAPD) data, despite notable differences in dialysis dynamics, solute clearance, and drug disposition between the two modalities. This discrepancy may result in subtherapeutic exposure or overtreatment, leading to poor clinical outcomes or drug toxicity.
Automated peritoneal dialysis is characterized by multiple, frequent short cycles of dialysate exchange during the night, along with a prolonged daytime dwell using icodextrin-based solutions. These unique features influence both the systemic absorption and elimination of intraperitoneally administered antibiotics. The pharmacokinetics of these antibiotics in APD patients, particularly with regard to intermittent i.p. dosing, remains insufficiently studied.
Read more
This single-center, open-label, randomized crossover study will evaluate plasma, dialysate, and urine concentrations of each antibiotic after both i.v. and i.p. administration in 24 adult patients (6 per drug group) receiving APD. Each subject will receive a single dose of one antibiotic (either 0.5g meropenem, 2g ampicillin, 1g aztreonam, or 400mg ciprofloxacin) via both routes, separated by a one-week washout period. Intraperitoneal administration will occur at the end of the cycler session, allowing the drug to dwell in 1.5L of icodextrin solution during the long daytime exchange.
Serial samples of plasma, peritoneal dialysate, and urine will be collected over a 24-hour period following each drug administration. High-performance liquid chromatography (HPLC) will be used to measure drug concentrations. Pharmacokinetic parameters to be calculated include area under the concentration-time curve (AUC), maximum concentration (Cmax), half-life (t½), and time to maximum concentration (Tmax). Secondary PK/PD indices such as time above the minimum inhibitory concentration (T>MIC) and AUC/MIC ratios will also be assessed to estimate the potential efficacy at the infection site.
The study drugs have well-characterized safety profiles and have been previously used via both i.v. and i.p. routes in CAPD and clinical practice. The study protocol includes safety monitoring, including assessment of adverse events, vital signs, hematology, and clinical chemistry parameters. Risks to subjects are considered minimal, primarily related to venous catheterization and single-dose drug administration. Participants are not expected to receive direct therapeutic benefit but will contribute to the optimization of antimicrobial therapy in APD patients with infections such as peritonitis and pneumonia.
This research addresses a critical gap in evidence-based dosing of antimicrobials in the APD population. Results from this study may inform future clinical guidelines and support rational selection and dosing of antibiotics in peritoneal dialysis-associated infections. It also offers insight into the feasibility of intermittent intraperitoneal therapy in APD patients and the systemic exposure achieved through this route. The study is conducted in accordance with Good Clinical Practice (GCP), the Declaration of Helsinki, and Austrian regulatory and ethical requirements.
- Conditions
- Peritoneal Dialysis-associated Peritonitis, Peritoneal Dialysis (PD), Pharmacokinetics, Intravenous Administration, Intravenous, Meropenem
- Being tested
- Application of intraperitoneal and intravenous meropenem in in automated peritoneal dialysis patients without peritonitis, Application of intraperitoneal and intravenous ampicillin in automated peritoneal dialysis patients without peritonitis, Application of intraperitoneal and intravenous aztreonam in automated peritoneal dialysis patients without peritonitis, Application of intraperitoneal and intravenous ciprofloxacin in automated peritoneal dialysis patients without peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of intraperitoneal and intravenous meropenem in in automated peritoneal dialysis patients without peritonitisDrug
Application of intraperitoneal and intravenous ampicillin in automated peritoneal dialysis patients without peritonitisDrug
Application of intraperitoneal and intravenous aztreonam in automated peritoneal dialysis patients without peritonitisDrug
Application of intraperitoneal and intravenous ciprofloxacin in automated peritoneal dialysis patients without peritonitisDrug
| Study group | Role | What they receive |
|---|---|---|
| ampicillin in APD patients without peritonitis | Experimental | Not described Receives: Drug: Application of intraperitoneal and intravenous ampicillin in automated peritoneal dialysis patients without peritonitis |
| meropenem in APD patients without peritonitis | Experimental | Not described Receives: Drug: Application of intraperitoneal and intravenous meropenem in in automated peritoneal dialysis patients without peritonitis |
| ciprofloxacin in APD patients without peritonitis | Experimental | Not described Receives: Drug: Application of intraperitoneal and intravenous ciprofloxacin in automated peritoneal dialysis patients without peritonitis |
| aztreonam in APD patients without peritonitis | Experimental | Not described Receives: Drug: Application of intraperitoneal and intravenous aztreonam in automated peritoneal dialysis patients without peritonitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (Area Under Curve)
Measured: 24 hours
Cmax (maximum concentration)
Measured: 24 hours
t½ (half-life)
Measured: 24 hours
tmax (time to Cmax)
Measured: 24 hours
Secondary outcomes (3)
T>MIC (time above minimum inhibitory concentration)
Measured: 24 hours
AUC₀-₂₄/MIC ratio
Measured: 24 hours
Compartmental AUC/Cmax ratios
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 start8 Apr 2014
- Primary completion7 Jul 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- 24 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, University of Vienna, Medical University of Cologne
- Responsible party
- Sponsor
- Investigators
- Martin Wiesholzer, MD, Principal investigator, UK St. Pölten - Deparment of Internal Medicine 1, Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113587
- Sponsor's protocol ID
- GS4-EK-2/301-2013
- Other IDs
- 2013-004985-32
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hextall A, Andrews JM, Donovan IA, Wise R. Intraperitoneal penetration of meropenem. J Antimicrob Chemother. 1991 Aug;28(2):314-6. doi: 10.1093/jac/28.2.314. No abstract available.
PubMed 1778863Manley 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 12437537Van 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 20200373Warady 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 22851742Li PK, Szeto CC, Piraino B, Bernardini J, Figueiredo AE, Gupta A, Johnson DW, Kuijper EJ, Lye WC, Salzer W, Schaefer F, Struijk DG; International Society for Peritoneal Dialysis. Peritoneal dialysis-related infections recommendations: 2010 update. Perit Dial Int. 2010 Jul-Aug;30(4):393-423. doi: 10.3747/pdi.2010.00049. No abstract available.
PubMed 20628102Salzer 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 16022084
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Intraperitoneal and Intravenous Meropenem, Ampicillin, Aztreonam and Ciprofloxacin in Automated Peritoneal Dialysis Patients Without Peritonitis
- ClinicalTrials.gov ID
- NCT07113587
- Acronym / sponsor ID
- GS4-EK-2/301-2013
- Conditions
- Peritoneal Dialysis-associated Peritonitis, Peritoneal Dialysis (PD), Pharmacokinetics, Intravenous Administration, Intravenous, Meropenem
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Karl Landsteiner Insitute for Nephrology and Haemato-OncologyResearch network
- Collaborators
- Karl Landsteiner University of Health Sciences, University of Vienna, Medical University of Cologne
- Study start
- 8 Apr 2014 (actual)
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 7 Jul 2017 (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.
This study aims to investigate the pharmacokinetics (PK) and pharmacodynamic (PD) profiles of four commonly used antibiotics - meropenem, ampicillin, aztreonam, and ciprofloxacin - administered via intravenous (i.v.) and intraperitoneal (i.p.) routes in patients undergoing automated peritoneal dialysis (APD) without peritonitis. Existing dosing regimens for APD patients are often extrapolated from continuous ambulatory peritoneal dialysis (CAPD) data, despite notable differences in dialysis dynamics, solute clearance, and drug disposition between the two modalities. This discrepancy may result in subtherapeutic exposure or overtreatment, leading to poor clinical outcomes or drug toxicity.
Automated peritoneal dialysis is characterized by multiple, frequent short cycles of dialysate exchange during the night, along with a prolonged daytime dwell using icodextrin-based solutions. These unique features influence both the systemic absorption and elimination of intraperitoneally administered antibiotics. The pharmacokinetics of these antibiotics in APD patients, particularly with regard to intermittent i.p. dosing, remains insufficiently studied.
This single-center, open-label, randomized crossover study will evaluate plasma, dialysate, and urine concentrations of each antibiotic after both i.v. and i.p. administration in 24 adult patients (6 per drug group) receiving APD. Each subject will receive a single dose of one antibiotic (either 0.5g meropenem, 2g ampicillin, 1g aztreonam, or 400mg ciprofloxacin) via both routes, separated by a one-week washout period. Intraperitoneal administration will occur at the end of the cycler session, allowing the drug to dwell in 1.5L of icodextrin solution during the long daytime exchange.
Serial samples of plasma, peritoneal dialysate, and urine will be collected over a 24-hour period following each drug administration. High-performance liquid chromatography (HPLC) will be used to measure drug concentrations. Pharmacokinetic parameters to be calculated include area under the concentration-time curve (AUC), maximum concentration (Cmax), half-life (t½), and time to maximum concentration (Tmax). Secondary PK/PD indices such as time above the minimum inhibitory concentration (T>MIC) and AUC/MIC ratios will also be assessed to estimate the potential efficacy at the infection site.
The study drugs have well-characterized safety profiles and have been previously used via both i.v. and i.p. routes in CAPD and clinical practice. The study protocol includes safety monitoring, including assessment of adverse events, vital signs, hematology, and clinical chemistry parameters. Risks to subjects are considered minimal, primarily related to venous catheterization and single-dose drug administration. Participants are not expected to receive direct therapeutic benefit but will contribute to the optimization of antimicrobial therapy in APD patients with infections such as peritonitis and pneumonia.
This research addresses a critical gap in evidence-based dosing of antimicrobials in the APD population. Results from this study may inform future clinical guidelines and support rational selection and dosing of antibiotics in peritoneal dialysis-associated infections. It also offers insight into the feasibility of intermittent intraperitoneal therapy in APD patients and the systemic exposure achieved through this route. The study is conducted in accordance with Good Clinical Practice (GCP), the Declaration of Helsinki, and Austrian regulatory and ethical requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ampicillin in APD patients without peritonitis | Experimental | Drug: Application of intraperitoneal and intravenous ampicillin in automated peritoneal dialysis patients without peritonitis |
| meropenem in APD patients without peritonitis | Experimental | Drug: Application of intraperitoneal and intravenous meropenem in in automated peritoneal dialysis patients without peritonitis |
| ciprofloxacin in APD patients without peritonitis | Experimental | Drug: Application of intraperitoneal and intravenous ciprofloxacin in automated peritoneal dialysis patients without peritonitis |
| aztreonam in APD patients without peritonitis | Experimental | Drug: Application of intraperitoneal and intravenous aztreonam in automated peritoneal dialysis patients without peritonitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-85 on APD using icodextrin.
- Informed consent provided.
- No recent infections or antibiotic use.
Key exclusion criteria (3 listed)
- Active systemic infection or recent peritonitis.
- Severe liver disease, pregnancy, allergy to study drugs.
- Hemoglobin <9 g/dL; BMI <19 or >35.
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 |
|---|---|---|
| Application of intraperitoneal and intravenous meropenem in in automated peritoneal dialysis patients without peritonitis | Drug | meropenem in APD patients without peritonitis |
| Application of intraperitoneal and intravenous ampicillin in automated peritoneal dialysis patients without peritonitis | Drug | ampicillin in APD patients without peritonitis |
| Application of intraperitoneal and intravenous aztreonam in automated peritoneal dialysis patients without peritonitis | Drug | aztreonam in APD patients without peritonitis |
| Application of intraperitoneal and intravenous ciprofloxacin in automated peritoneal dialysis patients without peritonitis | Drug | ciprofloxacin in APD patients without peritonitis |
Primary outcome
AUC (Area Under Curve)
Time frame: 24 hours
Cmax (maximum concentration)
Time frame: 24 hours
t½ (half-life)
Time frame: 24 hours
tmax (time to Cmax)
Time frame: 24 hours
3 secondary outcomes
T>MIC (time above minimum inhibitory concentration)
Time frame: 24 hours
AUC₀-₂₄/MIC ratio
Time frame: 24 hours
Compartmental AUC/Cmax ratios
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 14 Aug 2025.
- Background: PubMed 1778863Hextall A, Andrews JM, Donovan IA, Wise R. Intraperitoneal penetration of meropenem. J Antimicrob Chemother. 1991 Aug;28(2):314-6. doi: 10.1093/jac/28.2.314. No abstract available.
- 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 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 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 20628102Li PK, Szeto CC, Piraino B, Bernardini J, Figueiredo AE, Gupta A, Johnson DW, Kuijper EJ, Lye WC, Salzer W, Schaefer F, Struijk DG; International Society for Peritoneal Dialysis. Peritoneal dialysis-related infections recommendations: 2010 update. Perit Dial Int. 2010 Jul-Aug;30(4):393-423. doi: 10.3747/pdi.2010.00049. No abstract available.
- 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.
- Individual participant dataSharing planned: Yes
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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 Wiesholzer, MD principal investigator
UK St. Pölten - Deparment of Internal Medicine 1, Nephrology
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 Application of intraperitoneal and intravenous meropenem in in automated peritoneal dialysis patients without peritonitis, Application of intraperitoneal and intravenous ampicillin in automated peritoneal dialysis patients without peritonitis and Application of intraperitoneal and intravenous aztreonam in automated peritoneal dialysis patients without peritonitis 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 3 inclusion and 3 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 14 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?
AUC (Area Under Curve) (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 NCT07113587, which also lists 6 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 14 Aug 2025.