drugset / Trial / NCT04764058

Efficacy and Safety of Colistin Based Antibiotic Therapy

NCT04764058

Phase 1/2 Unknown 60 enrolled Ain Shams University
RandomizedParallel-groupOpen-labelOther

Summary

To evaluate the efficacy and safety of antibiotic combinations containing Colistin in the treatment of children with multidrug-resistant gram negative infections admitted in the pediatric surgery intensive care unit. The main outcome measure is clinical and microbiological responses to therapy. The secondary outcome is the occurrence of adverse events during Colistin combination treatment.

Timeline

Start
2017-09-01
Primary completion
2019-09-01
Completion
2021-09-01

Drugs

EvaluationDrugModalityDoseRoute
Background Cilastatin Small molecule Intravenous
Background IMIPENEM ANHYDROUS Small molecule 15 mg/kg Intravenous
Background IMIPENEM ANHYDROUS Small molecule 25 mg/kg Intravenous