PeritonitisNCT01785641
Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in CAPD Patients
A study testing ceftazidime+ciprofloxacin, ceftazidime monotherapy and cefazolin+gentamicin in people with Peritonitis, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
To compare the efficacy of single versus combined antibiotic therapy for bacterial peritonitis in CAPD patients. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Peritonitis
- What is being tested?
- ceftazidime+ciprofloxacin, ceftazidime monotherapy and cefazolin+gentamicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age >/= 18 years old
- ESRD patients on continuous ambulatory peritoneal dialysis more than 4 weeks
- presence of symptom or sign of peritonitis
- presence of WBC >100cell/mm3 with PMN >50% in peritoneal dialysate or gram stain positive for gram positive or gram negative bacteria
Who cannot join
- presence of polymicrobial organism, non-fermentative gram negative organism, fungus, mycobacteria in peritoneal fluid or culture-negative
- peritonitis from the organisms that required combined antibiotic therapy according to ISPD guideline 2010
- hospital-acquired peritonitis
- presence of catheter-related infection
- history of peritonitis within 4 weeks
- currently taking antibiotic
- allergic to the antibiotic that used in the study(penicillin or cephalosporin or quinolone or aminoglycoside)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in Continuous Ambulatory Peritoneal Dialysis Patients
To compare the efficacy of single versus combined antibiotic therapy for bacterial peritonitis in CAPD patients.
Read the detailed description
To compare relapse and recurrent rate of peritonitis between single and combined antibiotic regimens for bacterial peritonitis in CAPD patients.
- Conditions
- Peritonitis
- Being tested
- ceftazidime+ciprofloxacin, ceftazidime monotherapy, cefazolin+gentamicin, cefazolin monotherapy
- Keywords
- peritoneal dialysis, peritonitis
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftazidime+ciprofloxacinDrug
Also called combined antibiotic therapy
2 synergistic antibiotics: ceftazidime IP + ciprofloxacin po for gram negative bacterial peritonitis
ceftazidime monotherapyDrug
Also called monotherapy
ceftazidime IP for gram negative bacterial peritonitis
cefazolin+gentamicinDrug
Also called combined antibiotic therapy
cefazolin IP + gentamicin IP for gram positive bacterial peritonitis
cefazolin monotherapyDrug
Also called monotherapy
cefazolin IP for gram positive bacterial peritonitis
| Study group | Role | What they receive |
|---|---|---|
| ceftazidime+ciprofloxacin | Experimental | 2 synergistic antibiotics(ceftazidime IP and ciprofloxacin po for gram negative bacterial peritonitis) Receives: Drug: ceftazidime+ciprofloxacin |
| ceftazidime monotherapy | Active comparator | ceftazidime IP for gram negative bacterial peritonitis Receives: Drug: ceftazidime monotherapy |
| cefazolin+gentamicin | Experimental | cefazolin IP and gentamicin IP for gram positive bacterial peritonitis Receives: Drug: cefazolin+gentamicin |
| cefazolin monotherapy | Active comparator | cefazolin IP for gram positive bacterial peritonitis Receives: Drug: cefazolin monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse or recurrent rate
Measured: within 4 weeks after peritonitis treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nalinee Saiprasertkit, MD., Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785641
- Sponsor's protocol ID
- RA56/006
- Status last verified
- Feb 2013
- First submitted
- 30 Jan 2013
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in Continuous Ambulatory Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT01785641
- Acronym / sponsor ID
- RA56/006
- Conditions
- Peritonitis
- Keywords
- peritoneal dialysis, peritonitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Feb 2013 (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.
To compare the efficacy of single versus combined antibiotic therapy for bacterial peritonitis in CAPD patients.
Detailed description
To compare relapse and recurrent rate of peritonitis between single and combined antibiotic regimens for bacterial peritonitis in CAPD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ceftazidime+ciprofloxacin | Experimental | Drug: ceftazidime+ciprofloxacin2 synergistic antibiotics(ceftazidime IP and ciprofloxacin po for gram negative bacterial peritonitis) |
| ceftazidime monotherapy | Active comparator | Drug: ceftazidime monotherapyceftazidime IP for gram negative bacterial peritonitis |
| cefazolin+gentamicin | Experimental | Drug: cefazolin+gentamicincefazolin IP and gentamicin IP for gram positive bacterial peritonitis |
| cefazolin monotherapy | Active comparator | Drug: cefazolin monotherapycefazolin IP for gram positive bacterial peritonitis |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- age >/= 18 years old
- ESRD patients on continuous ambulatory peritoneal dialysis more than 4 weeks
- presence of symptom or sign of peritonitis
- presence of WBC >100cell/mm3 with PMN >50% in peritoneal dialysate or gram stain positive for gram positive or gram negative bacteria
Key exclusion criteria (7 listed)
- presence of polymicrobial organism, non-fermentative gram negative organism, fungus, mycobacteria in peritoneal fluid or culture-negative
- peritonitis from the organisms that required combined antibiotic therapy according to ISPD guideline 2010
- hospital-acquired peritonitis
- presence of catheter-related infection
- history of peritonitis within 4 weeks
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 |
|---|---|---|
| ceftazidime+ciprofloxacinAlso: combined antibiotic therapy2 synergistic antibiotics: ceftazidime IP + ciprofloxacin po for gram negative bacterial peritonitis | Drug | ceftazidime+ciprofloxacin |
| ceftazidime monotherapyAlso: monotherapyceftazidime IP for gram negative bacterial peritonitis | Drug | ceftazidime monotherapy |
| cefazolin+gentamicinAlso: combined antibiotic therapycefazolin IP + gentamicin IP for gram positive bacterial peritonitis | Drug | cefazolin+gentamicin |
| cefazolin monotherapyAlso: monotherapycefazolin IP for gram positive bacterial peritonitis | Drug | cefazolin monotherapy |
Primary outcome
relapse or recurrent rate
Time frame: within 4 weeks after peritonitis 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 21 Feb 2024.
Related trials for Peritonitis
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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.
Nalinee Saiprasertkit, MD. principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ceftazidime+ciprofloxacin, ceftazidime monotherapy and cefazolin+gentamicin in people with 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 4 inclusion and 7 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 21 Feb 2024. 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.
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?
relapse or recurrent rate (time frame: within 4 weeks after peritonitis treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2024.