An observational study in Bacterial Infections, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-15.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational
Patients may benefit from the personalized carbapenem dosing strategy based on pharmacokinetics. The objective of this study is to retrospectively review and analyze the clinical outcomes of patients with different dosing strategy.
Rational use of carbapenem is closely associated with the clinical outcome of patients with infections. Serum concentration of carbapenem varies from different populations. The objective of this study is to describe the clinical outcome of patients with infection treated by carbapenem in China, regarding diagnosis, treatment and follow-up. It is a single-center, retrospective, descriptive study. Inclusion criteria are an age ≥ 18, diagnosed as bacteria infection and serum concentration must be determined during therapy. Data concerning clinical presentation, biological samples, treatment and follow-up will be assessed. A descriptive analysis will be performed.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Chinese adult patients with bacterial infections treated by carbapenem
Age over 18 years Chinese patient: male or female Diagnosed as bacterial infection Treated by carbapenem Serum concentration determined during therapy
Exclusion Criteria:
Duration of carbapenem treatment less than 48 hours Patients renal or liver function not tested before treatment started Using more than two kinds of carbapenem
Patients with impaired renal function (eGFR \< 60ml/min/1.73m2) treated by carbapenem
Patients with liver cirrhosis or impaired liver function (Child-Pugh grade B or C) treated by carbapenem
Patients with co-morbidity of both liver cirrhosis or impaired liver function (Child-Pugh grade B or C) and impaired renal function (eGFR \< 60ml/min/1.73m2) treated by carbapenem
Patients with normal liver function or renal function treated by carbapenem
Mortality
30-day mortality and 90-day mortality
Time frame: January 2018-December 2021
Attainment of Target Trough Concentration
Attainment of Target Trough Concentration
Time frame: January 2018-December 2021
Proportion of patients reach clinical response at end of treatment
By definition, a successful clinical response means resolution of clinically significant signs and symptoms(defined as any criteria of systemic inflammatory response syndrome, body temperature over 38℃ or below 36℃, blood white cell count more than 12\*10\^9/L or less than 4\*10\^9/L, respiratory rate faster than 20 times per minute and heart rate higher than 90 beats per minute) or partial resolution of clinically significant signs and symptoms
Time frame: January 2018-December 2021
Proportion of patients reach clinical response at day 4 of treatment
By definition, a successful clinical response means resolution of clinically significant signs and symptoms(defined as any criteria of systemic inflammatory response syndrome, body temperature over 38℃ or below 36℃, blood white cell count more than 12\*10\^9/L or less than 4\*10\^9/L, respiratory rate faster than 20 times per minute and heart rate higher than 90 beats per minute) or partial resolution of clinically significant signs and symptoms
Time frame: January 2018-December 2021
Daily Sequential Organ Failure Assessment score change
Sequential Organ Failure Assessment score (Range from 0-24), lower score means a better outcome. Increase of 2 points within 48 hours means the presence of sepsis.
Time frame: January 2018-December 2021
Incidence of Septic Shock
Incidence of Septic Shock
Time frame: January 2018-December 2021
Safety outcome measures
Safety outcome measures including nephrotoxicity, hepatotoxicity and other adverse events related to the antibiotic treatment of carbapenems
Time frame: January 2018-December 2021
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School