PeritonitisNCT00497744
A Pharmacokinetic Study of Cefepime After Administration Into Dialysate in Patients With Continuous Ambulatory Peritoneal Dialysis (CAPD) Peritonitis
An observational study of Peritonitis, run by Hospital Authority, Hong Kong at 2 sites in China.
Trial summary
Cefepime is a broad-spectrum antibiotic used in treating CAPD peritonitis. However, medical knowledge has been lacking with regard to its pharmacokinetic profile after it has been administered intraperitoneally. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritonitis
- What is being tested?
- Intraperitoneal Cefepime
- How many people
- 6 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2005to Dec 2007
- Phase
- Observational
- 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
- Adult, Older adult
Study population: 4 males and 2 females, of age 57.83 +/-11.63 years with urinary creatinine clearance of 0.87+/-2.06ml/min/1.73m2 and admitted for CAPD peritonitis were enrolled. After collection of peritoneal dialysate for cell count and microbiological work-up, all subjects were loaded with 2g cefepime IP and dwelled for 6 hours. This was followed by 250mg cefepime in each subsequent 6-hourly peritoneal dialysis exchange. Plasma cefepime levels were determined at time 0, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120 hrs. Pharmacokinetic analyses were then performed.
Who may be able to join
- Age >= 18 years \& has been put on CAPD for >= 4 weeks before entering into the study
Who cannot join
- Known hypersensitivity to cefepime or other cephalosporin; CAPD peritonitis <= 28 days before being enrolled into the study
- Antibiotic treatment within 1 week prior to entry into the study
- Severe exit site or tunnel infection on the day of presentation
- Any conditions that prompt early removal of Tenckhoff catheter irrespective of clinical response to antibiotic treatment
- Abdominal malignancy; Any surgical causes of peritonitis
- Suspected or known fungal or tuberculous peritonitis
- History of dementia or known mental incompetency
Trial locations and contacts
2 sites in 1 country.
China2 sites
Caritas Medical Centre
Hong Kong
Princess Margaret Hospital
Hong Kong
About this study
Official title: Research Study on the Pharmacokinetic Profile of Intraperitoneal Cefepime in Patients With Continuous Ambulatory Peritoneal Dialysis (CAPD) Peritonitis
Cefepime is a broad-spectrum antibiotic used in treating CAPD peritonitis. However, medical knowledge has been lacking with regard to its pharmacokinetic profile after it has been administered intraperitoneally. The current study aims at determining the drug level at different time after the drug has been added into the peritoneal fluid in patients with CAPD peritonitis. The results of this study will finally leads to rational prescription of this drug at correct dosages.
- Conditions
- Peritonitis
- Being tested
- Intraperitoneal Cefepime
- Keywords
- CAPD peritonitis, Peritoneal Dialysis, Continuous Ambulatory
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal CefepimeDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startNov 2005
- Study completionDec 2007
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Investigators
- Sze Kit Yuen, Dr, Principal investigator, Department of Medicine and Geriatrics, Caritas Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497744
- Sponsor's protocol ID
- KW/EX/05-020
- Other IDs
- HARECCTR0500027
- Status last verified
- Jun 2011
- First submitted
- 6 Jul 2007
- Last updated
- 16 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Study on the Pharmacokinetic Profile of Intraperitoneal Cefepime in Patients With Continuous Ambulatory Peritoneal Dialysis (CAPD) Peritonitis
- ClinicalTrials.gov ID
- NCT00497744
- Acronym / sponsor ID
- KW/EX/05-020
- Conditions
- Peritonitis
- Keywords
- CAPD peritonitis, Peritoneal Dialysis, Continuous Ambulatory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- Nov 2005
- Study completion
- Dec 2007 (actual)
- First posted
- 9 Jul 2007 (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.
Cefepime is a broad-spectrum antibiotic used in treating CAPD peritonitis. However, medical knowledge has been lacking with regard to its pharmacokinetic profile after it has been administered intraperitoneally. The current study aims at determining the drug level at different time after the drug has been added into the peritoneal fluid in patients with CAPD peritonitis. The results of this study will finally leads to rational prescription of this drug at correct dosages.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 4 males and 2 females, of age 57.83 +/-11.63 years with urinary creatinine clearance of 0.87+/-2.06ml/min/1.73m2 and admitted for CAPD peritonitis were enrolled. After collection of peritoneal dialysate for cell count and microbiological work-up, all subjects were loaded with 2g cefepime IP and dwelled for 6 hours. This was followed by 250mg cefepime in each subsequent 6-hourly peritoneal dialysis exchange. Plasma cefepime levels were determined at time 0, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120 hrs. Pharmacokinetic analyses were then performed.
Key inclusion criteria (1 listed)
- Age >= 18 years \& has been put on CAPD for >= 4 weeks before entering into the study
Key exclusion criteria (7 listed)
- Known hypersensitivity to cefepime or other cephalosporin; CAPD peritonitis <= 28 days before being enrolled into the study
- Antibiotic treatment within 1 week prior to entry into the study
- Severe exit site or tunnel infection on the day of presentation
- Any conditions that prompt early removal of Tenckhoff catheter irrespective of clinical response to antibiotic treatment
- Abdominal malignancy; Any surgical causes of peritonitis
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 |
|---|---|---|
| Intraperitoneal Cefepime | Drug | – |
Primary outcome
Not reported in the source record.
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 16 Jun 2011.
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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.
Sze Kit Yuen, Dr principal investigator
Department of Medicine and Geriatrics, Caritas Medical Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritonitis, run by Hospital Authority, Hong Kong at 2 sites in China.
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 1 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 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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.
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 16 Jun 2011.