NCT04505748 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

de Klaver PA, Hendriks JG, van Onzenoort HA, Schreurs BW, Touw DJ, Derijks LJ
Gentamicin serum concentrations in patients with gentamicin-PMMA beads for infected hip joints: a prospective observational cohort study. Ther Drug Monit. 2012 Feb;34(1):67-71.
Parvizi J, Saleh KJ, Ragland PS, Pour AE, Mont MA
Efficacy of antibiotic-impregnated cement in total hip replacement. Acta Orthop. 2008 Jun;79(3):335-41. doi: 10.1080/17453670710015229.
Patrick BN, Rivey MP, Allington DR
Acute renal failure associated with vancomycin- and tobramycin-laden cement in total hip arthroplasty. Ann Pharmacother. 2006 Nov;40(11):2037-42. Epub 2006 Oct 10.

Is Serum Gentamicin Concentration Modified With Autologous Cell-saved Blood Transfusion After Total Knee Arthroplasty Using Tranexamic Acid: A Randomized Control Trial

Details for clinical trial NCT04505748

Clinical trial NCT04505748 - References