Hospital InfectionPhase 4NCT04995133
Colistin Intravenous Administration in Critically Ill Patients Suffering From Hospital Infections Caused by Multi-antibiotic-resistant Germs.
A Phase 4 study testing Colistin in people with Hospital Infection and Multi-antibiotic Resistance, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Colistin is an antibiotic active against several classes of multi-resistant gram-negative bacteria; the drug should be used in high doses in patients on continuous renal replacement therapy, since the drug is eliminated through the dialysis filter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Infection, Multi-antibiotic Resistance, Critically Ill
- 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
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jul 2021to 30 Jan 2022
- 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
- Infection where the involvement of MDR germs is documented or highly probable
- Continuous renal replacement therapy
- Acute renal failure, stage III of the 2012 KDIGO classification
- Half-life of the continuous renal replacement therapy filter less than 48 hours.
Who cannot join
- State of pregnancy or breastfeeding, or patients expecting to conceive children within the projected duration of the study, starting with the screening through 30 days after the last dose of IMP treatment
- Patients with a positive urine pregnancy test within 72 hours prior to study drug treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication
- Women of childbearing potential
- Refusal of informed consent
- Known hypersensitivity to polymyxins and to excipients
- Clinical condition with high probability of death, according to Symplified Acute Physiology Score (SAPS II)
Show all 10Show fewer
- Partial maintenance of renal function, defined by stages I and II of the 2012 KDIGO classification.
- Renal replacement therapy filter other than AN69 ST 150
- Prior systemic treatments with any investigational agents within 4 weeks prior to the inclusion in the trial
- Any other clinical condition that, in the opinion of the investigator, makes the patient unfit for the trial
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico A.Gemelli IRCSS
Roma, Italia, 00168
Margherita Zona, +390630155701, margherita.zona@policlinicogemelli.it
About this study
Official title: Pharmacokinetic/Pharmacodynamic Aspects of Colistin Intravenous Administration in Critically Ill Patients Suffering From Hospital Infections Caused by Multi-antibiotic-resistant Germs and Receiving Continuous Renal Replacement Therapy.
Colistin is an antibiotic active against several classes of multi-resistant gram-negative bacteria; the drug should be used in high doses in patients on continuous renal replacement therapy, since the drug is eliminated through the dialysis filter.
This is an Open-label, Phase 4, interventional, prospective, single-center pilot study aimed to analyze the concentrations of colistin in plasma and ultrafiltrate by liquid chromatography/mass spectrometry, in 20 critically ill patients admitted to intensive care and suffering from severe infections by multi-resistant bacteria, who receive continuous renal replacement therapy.
- Being tested
- Colistin
- Keywords
- Colistin
- Medical subject headings
- Cross Infection, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColistinDrug
intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Colistin Arm | Experimental | Intravenous administration of 6.75 x 106 Units Colistin for 30 minutes Receives: Drug: Colistin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC)
Colistin A and B misuration in the plasma and in the pre-post filter.
Measured: 0-12 hours
Peak plasma concentration
Colistin A and B misuration in the plasma
Measured: 0-12 hours
Half-life
Colistin A and B misuration in the plasma
Measured: 0-12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start14 Jul 2021
- Primary completion30 Jan 2022 (estimated)
- Study completion30 Jan 2022 (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 Hospital InfectionStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NAVARRA PIERLUIGI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995133
- Sponsor's protocol ID
- 3946
- Status last verified
- Aug 2021
- First submitted
- 23 Jul 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Pascale G, Lisi L, Cutuli SL, Marinozzi C, Palladini A, Ferrando ES, Tanzarella ES, Lombardi G, Grieco DL, Caroli A, Xhemalaj R, Cascarano L, Ciotti GMP, Sandroni C, Sanguinetti M, Navarra P, Antonelli M. High-dose colistin pharmacokinetics in critically ill patients receiving continuous renal replacement therapy. Ann Intensive Care. 2024 Sep 28;14(1):152. doi: 10.1186/s13613-024-01384-1.
PubMed 39340688
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic/Pharmacodynamic Aspects of Colistin Intravenous Administration in Critically Ill Patients Suffering From Hospital Infections Caused by Multi-antibiotic-resistant Germs and Receiving Continuous Renal Replacement Therapy.
- ClinicalTrials.gov ID
- NCT04995133
- Acronym / sponsor ID
- 3946
- Keywords
- Colistin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 6 Aug 2021 (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.
Colistin is an antibiotic active against several classes of multi-resistant gram-negative bacteria; the drug should be used in high doses in patients on continuous renal replacement therapy, since the drug is eliminated through the dialysis filter.
This is an Open-label, Phase 4, interventional, prospective, single-center pilot study aimed to analyze the concentrations of colistin in plasma and ultrafiltrate by liquid chromatography/mass spectrometry, in 20 critically ill patients admitted to intensive care and suffering from severe infections by multi-resistant bacteria, who receive continuous renal replacement therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colistin Arm | Experimental | Drug: ColistinIntravenous administration of 6.75 x 106 Units Colistin for 30 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Infection where the involvement of MDR germs is documented or highly probable
- Continuous renal replacement therapy
- Acute renal failure, stage III of the 2012 KDIGO classification
- Half-life of the continuous renal replacement therapy filter less than 48 hours.
Key exclusion criteria (10 listed)
- State of pregnancy or breastfeeding, or patients expecting to conceive children within the projected duration of the study, starting with the screening through 30 days after the last dose of IMP treatment
- Patients with a positive urine pregnancy test within 72 hours prior to study drug treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication
- Women of childbearing potential
- Refusal of informed consent
- Known hypersensitivity to polymyxins and to excipients
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 |
|---|---|---|
| Colistinintravenous administration | Drug | Colistin Arm |
Primary outcome
Area under the plasma concentration versus time curve (AUC)
Time frame: 0-12 hours
Colistin A and B misuration in the plasma and in the pre-post filter.
Peak plasma concentration
Time frame: 0-12 hours
Colistin A and B misuration in the plasma
Half-life
Time frame: 0-12 hours
Colistin A and B misuration in the plasma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Derived from this study: PubMed 39340688De Pascale G, Lisi L, Cutuli SL, Marinozzi C, Palladini A, Ferrando ES, Tanzarella ES, Lombardi G, Grieco DL, Caroli A, Xhemalaj R, Cascarano L, Ciotti GMP, Sandroni C, Sanguinetti M, Navarra P, Antonelli M. High-dose colistin pharmacokinetics in critically ill patients receiving continuous renal replacement therapy. Ann Intensive Care. 2024 Sep 28;14(1):152. doi: 10.1186/s13613-024-01384-1.
- Individual participant dataSharing planned: Undecided
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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.
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 Hospital Infection and Multi-antibiotic Resistance, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 10 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 6 Aug 2021. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve (AUC) (time frame: 0-12 hours). The study lists 3 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 NCT04995133, 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 6 Aug 2021.