InfectionPhase 4NCT02081560
Colistin Pharmacokinetics in Continuous Renal Replacement Therapy
A Phase 4 study testing Colistin in people with Infection, run by University of Zurich at 1 site in Switzerland.
Trial summary
The blood concentration of the antibiotic colistin is determined in patients in whom kidney function is reduced such that a renal replacement therapy is needed. Hypothesis:no dose reduction is needed in patients undergoing continuous renal replacement therapy over 24h because colistin is sufficiently removed by this… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Colistin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2013to Aug 2015
- 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
- male or female aged 18 years or older
- hospitalised on the ICU
- gram-negative infection requiring antibiotic therapy with intravenous colistin as part of their routine medical care
- clinical necessity for continuous venovenous renal replacement therapy
Who cannot join
- History of hypersensitivity to colistin or to other polymyxins
- Personal or family history of Myasthenia Gravis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Zurich, Dept. of Pharmacology and Toxicology
Zurich, Canton of Zurich, 8091
Natascia Corti, MD, 041 (0) 44 255 20 78, natascia.corti@usz.ch
Natascia Corti, MD
About this study
Official title: Colistimethate and Colistin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy (CRRT)
The blood concentration of the antibiotic colistin is determined in patients in whom kidney function is reduced such that a renal replacement therapy is needed.
Hypothesis:no dose reduction is needed in patients undergoing continuous renal replacement therapy over 24h because colistin is sufficiently removed by this procedure.
Read the detailed description
After administration of intravenous Colistin multiple blood samples are drawn over one dosing interval on day 1, 3, and 5 of treatment.
Patients are monitored for signs of neuro- and nephrotoxicity
- Conditions
- Infection
- Being tested
- Colistin
- Keywords
- pharmacokinetics, antibiotic, Gram negative, continuous renal replacement therapy
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColistinDrug
Colistin i.v. three times daily as long a necessary for infection treatment
| Study group | Role | What they receive |
|---|---|---|
| colistin pharmacokinetics | Other | Intravenous colistin 9 million units loading dose and 3 million units q8h maintenance dose as long as treatment of infection is required Receives: Drug: Colistin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC)
Measured: predose, and 0.5, 1, 2, 4, 6, 8 hours after administration
Secondary outcomes (2)
Sings of neurotoxicity and nephrotoxicity
Clinical investigation daily by assessing clinical signs and questioning the patient regarding sign of neuropathy and difficulty breathing in non intubated patients. Questioning the treating physician in intubated patients regarding objective signs of increased ventilation support.
Measured: Expected average of follow up is about 14 days.
Sings of neurotoxicity and nephrotoxicity
Clinical investigation daily by assessing clinical signs and questioning the patient regarding sign of neuropathy and difficulty breathing in non intubated patients. Questioning the treating physician in intubated patients regarding objective signs of increased ventilation support. The patients will be followed for the duration of colistin administration at the dose studied.
Measured: Expected average of follow up is about 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startNov 2013
- Primary completionJul 2015 (estimated)
- Study completionAug 2015 (estimated)
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 InfectionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natascia Corti, MD, Principal investigator, University Hospital Zurich, Dept. of Pharmacology and Toxicology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081560
- Sponsor's protocol ID
- COLPKZH11
- Other IDs
- 213DR11032
- Status last verified
- Mar 2014
- First submitted
- 27 Feb 2014
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Leuppi-Taegtmeyer AB, Decosterd L, Osthoff M, Mueller NJ, Buclin T, Corti N. Multicenter Population Pharmacokinetic Study of Colistimethate Sodium and Colistin Dosed as in Normal Renal Function in Patients on Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2019 Jan 29;63(2):e01957-18. doi: 10.1128/AAC.01957-18. Print 2019 Feb.
PubMed 30478168
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colistimethate and Colistin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy (CRRT)
- ClinicalTrials.gov ID
- NCT02081560
- Acronym / sponsor ID
- COLPKZH11
- Conditions
- Infection
- Keywords
- pharmacokinetics, antibiotic, Gram negative, continuous renal replacement therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 7 Mar 2014 (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 blood concentration of the antibiotic colistin is determined in patients in whom kidney function is reduced such that a renal replacement therapy is needed.
Hypothesis:no dose reduction is needed in patients undergoing continuous renal replacement therapy over 24h because colistin is sufficiently removed by this procedure.
Detailed description
After administration of intravenous Colistin multiple blood samples are drawn over one dosing interval on day 1, 3, and 5 of treatment.
Patients are monitored for signs of neuro- and nephrotoxicity
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colistin pharmacokinetics | Other | Drug: ColistinIntravenous colistin 9 million units loading dose and 3 million units q8h maintenance dose as long as treatment of infection is required |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male or female aged 18 years or older
- hospitalised on the ICU
- gram-negative infection requiring antibiotic therapy with intravenous colistin as part of their routine medical care
- clinical necessity for continuous venovenous renal replacement therapy
Key exclusion criteria (2 listed)
- History of hypersensitivity to colistin or to other polymyxins
- Personal or family history of Myasthenia Gravis
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 |
|---|---|---|
| ColistinColistin i.v. three times daily as long a necessary for infection treatment | Drug | colistin pharmacokinetics |
Primary outcome
Area under the curve (AUC)
Time frame: predose, and 0.5, 1, 2, 4, 6, 8 hours after administration
2 secondary outcomes
Sings of neurotoxicity and nephrotoxicity
Time frame: Expected average of follow up is about 14 days.
Sings of neurotoxicity and nephrotoxicity
Time frame: Expected average of follow up is about 14 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
- Derived from this study: PubMed 30478168Leuppi-Taegtmeyer AB, Decosterd L, Osthoff M, Mueller NJ, Buclin T, Corti N. Multicenter Population Pharmacokinetic Study of Colistimethate Sodium and Colistin Dosed as in Normal Renal Function in Patients on Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2019 Jan 29;63(2):e01957-18. doi: 10.1128/AAC.01957-18. Print 2019 Feb.
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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.
Natascia Corti, MD principal investigator
University Hospital Zurich, Dept. of Pharmacology and Toxicology
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 Colistin in people with Infection, run by University of Zurich at 1 site in Switzerland.
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 2 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: status not confirmed, as of the sponsor's last update on 7 Mar 2014. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natascia Corti, MD (044 255 20 78, natascia.corti@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) (time frame: predose, and 0.5, 1, 2, 4, 6, 8 hours after administration). 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 NCT02081560, 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 7 Mar 2014.