At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 12 enrolled
Drug / intervention
Pioglitazone hydrochloridedrug
Likely dose
Pioglitazone hydrochloride 0.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetic Characteristics of Pioglitazone and Preliminary Biomarker Response in Adolescents Aged 12 to 17 Years With Severe Sepsis and Septic Shock
Children's Hospital Medical Center, Cincinnati·interventional·Posted May 11, 2011·Updated Sep 2, 2020
In Brief
A Phase 2 clinical trial evaluating Pioglitazone hydrochloride for Severe Sepsis and Septic Shock. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the pharmacokinetics of pioglitazone and to determine the effect on inflammatory biomarkers for pioglitazone in patients with severe sepsis and septic shock.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Sepsis, Septic Shock
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartOct 2011
Primary CompletionMay 2016
Study CompletionJan 2017
TodayJul 2026
First PostedMay 11, 2011
Enrollment StartOct 1, 2011
Primary CompletionMay 1, 2016
Study CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 15.1 years ago
Interventions
Pioglitazone hydrochloridedrug
Participants will receive a daily dose of pioglitazone at 0.5 mg/kg/dose for 5 days.