Peritoneal Dialysis Associated PeritonitisPhase 4NCT02872038
Comparing Cefepime Versus Cefazolin Plus Ceftazidime for CAPD-associated Peritonitis
A Phase 4 study testing Cefepime and Cefazolin plus Ceftazidime in people with Peritoneal Dialysis Associated Peritonitis, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The purpose of this study is to compare the efficacy of empirical antibiotics of CAPD-associated peritonitis with intraperitoneal, continuous dosing of cefepime monotherapy versus combination of cefazolin and ceftazidime. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis Associated Peritonitis
- What is being tested?
- Cefepime and Cefazolin plus Ceftazidime
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2015to 30 Nov 2016
- Phase
- Phase 4
- 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
- Age more than 18 years
- CAPD initiation more than 4 weeks
Who cannot join
- Exit site or tunnel infection
- Sepsis
- Previous CAPD-associated peritonitis treatment within 4 weeks
- Drug allergy to cephalosporin
- Tenckhoff catheter malfunction
- Hospitalization more than 48 hours
Show all 9Show fewer
- Fungal or Mycobacterium infection
- Suspected secondary peritonitis
- Concomitant antibiotics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Controlled Trial Comparing Cefepime Monotherapy Versus Combination of Cefazolin Plus Ceftazidime for Empirical Treatment of CAPD-associated Peritonitis
The purpose of this study is to compare the efficacy of empirical antibiotics of CAPD-associated peritonitis with intraperitoneal, continuous dosing of cefepime monotherapy versus combination of cefazolin and ceftazidime. Patients were randomized to be administered either intraperitoneal cefepime 1 g loading then 250 mg all exchanges (treatment group) or cefazolin and ceftazidime (control group) in the same dose.
Read the detailed description
The International Society of Peritoneal Dialysis (ISPD) guideline suggest to use combination of antibiotics to cover both of gram positive and gram negative bacteria. The usual regimen in Thailand is cefazolin plus ceftazidime. Despite combination therapy, monotherapy is also possible for empirical treatment of CAPD-associated peritonitis since it helps to lowering staff burden and lowering risk of contamination. Cefepime could be an ideal antibiotic for empirical treatment of CAPD-associated peritonitis as it is an extended-spectrum cephalosporin, forth generation, covering most of gram positive and gram negative bacteria. In addition, cefepime is not broken down by many of the beta-lactamases and less beta-lactamases inducer. This study aims to prove the noninferiority of cefepime monotherapy to cefazolin plus ceftazidime for empirical treatment of CAPD-associated peritonitis.
CAPD-associated peritonitis was diagnosed by at least two of the following criteria: abdominal pain or cloudy peritoneal dialysis fluid (PDF); PDF white cell count > 100/μL with > 50% polymorphonuclear(PMN); and positive gram stain or culture. The patients were randomized into two groups by block of four randomization, sealed envelope. Treatment group was treated with intraperitoneal (IP) cefepime 1 g loading following by maintenance dose 250 mg IP all exchanges. Control group was treated with cefazolin 1 g IP loading and ceftazidime 1 g IP loading following by maintenance dose of cefazolin and ceftazidime 250 mg IP all exchanges. If a patient had residual urine ≥ 100 ml/day, dose of antibiotics would be increased by 25%.
On the first day, the initial blood tests for complete blood count, electrolyte, BUN, creatinine, calcium, phosphate and magnesium were obtained. While peritoneal dialysis fluid were collected using two methods of bacterial culture, both of centrifugation of 50 ml peritoneal dialysis fluid at 3,000 g for 15 minutes and bedside 5-10 ml of peritoneal dialysis fluid inoculated into the blood culture bottles. PDF gram stain and bacterial culture were done. The patients were followed on day 3, 5, 10, 14, 21 and 28 days after the completion of antibiotic course. If clinical improved, the antibiotics would be adjusted according to the culture result and sensitivity after day 5. If clinical not improved the antibiotics would be step up and Tenckhoff catheter removal was considered (on any day of treatment). The patients were treated at least 14 days or 21 days depend on the culture result (as the recommendation of ISPD guideline 2010).
- Being tested
- Cefepime, Cefazolin plus Ceftazidime
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefepimeDrug
Cefepime intraperitoneal continuous dosing
Cefazolin plus CeftazidimeDrug
Also called Control group
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Cefepime intraperitoneal continuous dosing Receives: Drug: Cefepime |
| Control | Active comparator | Cefazolin plus Ceftazidime intraperitoneal continuous dosing Receives: Drug: Cefazolin plus Ceftazidime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary response rate
Resolution of clinical peritonitis and peritoneal dialysis fluid WBC < 100 /μL with PMN < 50% at day 10
Measured: day 10 of treatment
Secondary outcomes (1)
Initial response rate
Resolution of clinical peritonitis and peritoneal dialysis fluid WBC < 100 /μL with PMN < 50% at day 5
Measured: day 5 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startAug 2015
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- The Kidney Foundation of Thailand, Siam Pharmaceutical Co Ltd
- Responsible party
- Principal investigator, Thidarat Kitrungphaiboon, MD, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872038
- Sponsor's protocol ID
- MONOCEF
- Status last verified
- Oct 2017
- First submitted
- 25 Jul 2016
- Last updated
- 31 Oct 2017
- Results posted
- No
Publications
Kitrungphaiboon T, Puapatanakul P, Chuengsaman P, Tiskajornsiri K, Halue G, Siribamrungwong M, Matayart S, Chongthanakorn K, Poonvivatchaikarn U, Boonyakrai C, Somboonsilp W, Katavetin P, Praditpornsilpa K, Eiam-Ong S, Johnson DW, Kanjanabuch T. Intraperitoneal Cefepime Monotherapy Versus Combination Therapy of Cefazolin Plus Ceftazidime for Empirical Treatment of CAPD-Associated Peritonitis: A Multicenter, Open-Label, Noninferiority, Randomized, Controlled Trial. Am J Kidney Dis. 2019 Nov;74(5):601-609. doi: 10.1053/j.ajkd.2019.05.011. Epub 2019 Jul 19.
PubMed 31331757
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Trial Comparing Cefepime Monotherapy Versus Combination of Cefazolin Plus Ceftazidime for Empirical Treatment of CAPD-associated Peritonitis
- ClinicalTrials.gov ID
- NCT02872038
- Acronym / sponsor ID
- MONOCEF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- The Kidney Foundation of Thailand, Siam Pharmaceutical Co Ltd
- Study start
- Aug 2015
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of empirical antibiotics of CAPD-associated peritonitis with intraperitoneal, continuous dosing of cefepime monotherapy versus combination of cefazolin and ceftazidime. Patients were randomized to be administered either intraperitoneal cefepime 1 g loading then 250 mg all exchanges (treatment group) or cefazolin and ceftazidime (control group) in the same dose.
Detailed description
The International Society of Peritoneal Dialysis (ISPD) guideline suggest to use combination of antibiotics to cover both of gram positive and gram negative bacteria. The usual regimen in Thailand is cefazolin plus ceftazidime. Despite combination therapy, monotherapy is also possible for empirical treatment of CAPD-associated peritonitis since it helps to lowering staff burden and lowering risk of contamination. Cefepime could be an ideal antibiotic for empirical treatment of CAPD-associated peritonitis as it is an extended-spectrum cephalosporin, forth generation, covering most of gram positive and gram negative bacteria. In addition, cefepime is not broken down by many of the beta-lactamases and less beta-lactamases inducer. This study aims to prove the noninferiority of cefepime monotherapy to cefazolin plus ceftazidime for empirical treatment of CAPD-associated peritonitis.
CAPD-associated peritonitis was diagnosed by at least two of the following criteria: abdominal pain or cloudy peritoneal dialysis fluid (PDF); PDF white cell count > 100/μL with > 50% polymorphonuclear(PMN); and positive gram stain or culture. The patients were randomized into two groups by block of four randomization, sealed envelope. Treatment group was treated with intraperitoneal (IP) cefepime 1 g loading following by maintenance dose 250 mg IP all exchanges. Control group was treated with cefazolin 1 g IP loading and ceftazidime 1 g IP loading following by maintenance dose of cefazolin and ceftazidime 250 mg IP all exchanges. If a patient had residual urine ≥ 100 ml/day, dose of antibiotics would be increased by 25%.
On the first day, the initial blood tests for complete blood count, electrolyte, BUN, creatinine, calcium, phosphate and magnesium were obtained. While peritoneal dialysis fluid were collected using two methods of bacterial culture, both of centrifugation of 50 ml peritoneal dialysis fluid at 3,000 g for 15 minutes and bedside 5-10 ml of peritoneal dialysis fluid inoculated into the blood culture bottles. PDF gram stain and bacterial culture were done. The patients were followed on day 3, 5, 10, 14, 21 and 28 days after the completion of antibiotic course. If clinical improved, the antibiotics would be adjusted according to the culture result and sensitivity after day 5. If clinical not improved the antibiotics would be step up and Tenckhoff catheter removal was considered (on any day of treatment). The patients were treated at least 14 days or 21 days depend on the culture result (as the recommendation of ISPD guideline 2010).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: CefepimeCefepime intraperitoneal continuous dosing |
| Control | Active comparator | Drug: Cefazolin plus CeftazidimeCefazolin plus Ceftazidime intraperitoneal continuous dosing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age more than 18 years
- CAPD initiation more than 4 weeks
Key exclusion criteria (9 listed)
- Exit site or tunnel infection
- Sepsis
- Previous CAPD-associated peritonitis treatment within 4 weeks
- Drug allergy to cephalosporin
- Tenckhoff catheter malfunction
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 |
|---|---|---|
| CefepimeCefepime intraperitoneal continuous dosing | Drug | Treatment |
| Cefazolin plus CeftazidimeAlso: Control group | Drug | Control |
Primary outcome
Primary response rate
Time frame: day 10 of treatment
Resolution of clinical peritonitis and peritoneal dialysis fluid WBC < 100 /μL with PMN < 50% at day 10
1 secondary outcome
Initial response rate
Time frame: day 5 of treatment
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 31 Oct 2017.
- Derived from this study: PubMed 31331757Kitrungphaiboon T, Puapatanakul P, Chuengsaman P, Tiskajornsiri K, Halue G, Siribamrungwong M, Matayart S, Chongthanakorn K, Poonvivatchaikarn U, Boonyakrai C, Somboonsilp W, Katavetin P, Praditpornsilpa K, Eiam-Ong S, Johnson DW, Kanjanabuch T. Intraperitoneal Cefepime Monotherapy Versus Combination Therapy of Cefazolin Plus Ceftazidime for Empirical Treatment of CAPD-Associated Peritonitis: A Multicenter, Open-Label, Noninferiority, Randomized, Controlled Trial. Am J Kidney Dis. 2019 Nov;74(5):601-609. doi: 10.1053/j.ajkd.2019.05.011. Epub 2019 Jul 19.
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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 Phase 4 study testing Cefepime and Cefazolin plus Ceftazidime in people with Peritoneal Dialysis Associated Peritonitis, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 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 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Primary response rate (time frame: day 10 of treatment). 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 NCT02872038, which also lists 1 linked publication.
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 31 Oct 2017.