Last reviewed · How we verify
NCT02288429
Evaluation of Steady-state Pharmacokinetic and Pharmacodynamic Properties of Intravenous Colistimethate Sodium in Cystic Fibrosis and Critically Ill Patients
trial testing colistimethate sodium in Colistin in 16 participants. Completed in 1 June 2019.
1 June 2019
Quick facts
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 16 |
| Start date | 1 September 2013 |
| Primary completion | 1 June 2019 |
| Estimated completion | 1 June 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- colistimethate sodium (COLISTIMETHATE SODIUM) — full drug profile →
Conditions studied
- Colistin — all drugs for Colistin →
Sponsor
University of Colorado, Denver
Who can join
Adults 18 to 89, any sex, with Colistin. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Area under the plasma concentration time curve (AUC0-24)
Time frame: 0, 30, 60, 120, 240, and 360 minutes after the IV infusion
Steady-state plasma concentrations will be obtained after at least 2 days of therapy. Blood draws (5 ml) will be taken just before the start of the colistimethate sodium infusion and at 30, 60, 120, 240, and 360 minutes after the IV infusion.
Sponsor's own description
Colistin is a polymixin antibiotic used in the treatment of multidrug-resistant gram-negative infections. Given the limited use of colistin and previous challenges with laboratory assays to determine plasma concentrations, there is a lack of knowledge of the pharmacokinetic profile of colistin. The purpose of the investigators observational prospective pharmacokinetic cohort study is to examine the steady-state pharmacokinetic and pharmacodynamic properties of intravenous colistimethate sodium in cystic fibrosis and critically ill patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02288429
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of colistimethate sodium
Trials testing the same drug.
- NCT06488794 — Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia · Phase 2, PHASE3 · not yet recruiting
Other University of Colorado, Denver trials
Trials by the same sponsor.
- NCT07292285 — The Surveillance Nonoperative Watch & Wait (SNOWW) Rectal Cancer Trial. · not yet recruiting
- NCT07021937 — Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity · Phase 3 · not yet recruiting
- NCT07453732 — Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients. · NA · not yet recruiting
- NCT07038278 — 5-AminoLevulinic Acid Aided Resection Margins in Sarcoma · EARLY_PHASE1 · not yet recruiting
- NCT07279558 — Cannabidiol and Alcohol Use Disorder Phenotypes · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02288429 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
- Last refreshed: 20 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02288429.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing