Colistin Intravenous Administration in Critically Ill Patients Suffering From Hospital Infections Caused by Multi-antibiotic-resistant Germs.

NCT ID: NCT04995133

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-14
• Study Completion Date: 2022-01-30

Brief 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.

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.

Conditions

Hospital Infection; Multi-antibiotic Resistance; Critically Ill

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Colistin Arm

Intravenous administration of 6.75 x 106 Units Colistin for 30 minutes

Group Type: EXPERIMENTAL

Colistin

Intervention Type: DRUG

intravenous administration

Interventions

Colistin

intravenous administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

NAVARRA PIERLUIGI

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico A.Gemelli IRCSS

Roma, Italia, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Margherita Zona

Role: primary

margherita.zona@policlinicogemelli.it

+390630155701

References

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.

Reference Type: DERIVED

PMID: 39340688 (View on PubMed)

Other Identifiers

3946

Identifier Type: -

Identifier Source: org_study_id