NCT02616354

Brief Summary

Explore Imipenem/Cilastatin two-step dosing compared to 2 hours infusion in patients with severe whether can obtain better results of the pharmacokinetic/pharmacodynamic, for clinical rational use of antimicrobial agents, and provide theoretical support for optimizing dosage regimen.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_4 sepsis

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_4 sepsis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 26, 2015

Status Verified

November 1, 2015

Enrollment Period

10 months

First QC Date

November 13, 2015

Last Update Submit

November 24, 2015

Conditions

Sepsis

Keywords

Pharmacokinetics; pharmacodynamic; imipenem; sepsis

Outcome Measures

Primary Outcomes (1)

  • Area under the plasma concentration versus time curve (AUC)

    up to 9 months

Secondary Outcomes (1)

  • Plasma Concentration

    up to 9 months

Other Outcomes (1)

  • PK/PD indices

    up to 9 moths

Study Arms (2)

Group I

ACTIVE COMPARATOR

Group I received intravenous imipenem/cilastatin 1 g every 8 h (q8h) or 0.5g every 6 h (q6h) with optimized two-step infusion therapy (OTIT; rapid first-step infusion in 30 min and slow second-step infusion above 1.5 hours) "Group I" is more informative than "Group II" from PK parameters(%T\>MIC,AUC/MIC).

Drug: Imipenem

Group II

PLACEBO COMPARATOR

group II received intravenous imipenem/cilastatin 1g q8h or 0.5g q6h with extended infusion therapy (2-hours continuous infusion in a constant speed). "Group I" is more informative than "Group II" from PK parameters(%T\>MIC,AUC/MIC).

Drug: Imipenem

Interventions

ImipenemDRUG

Patients in group I received a dose of imipenem/cilastatin 1g each every 8 hours or 0.5g every 6 hours optimized two-step infusion therapy (rapid first-step infusion in 30 min and slow second-step infusion above 1.5 hours)

Also known as: Optimized two-step infusion therapy
Group IGroup II

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sepsis or severe sepsis or severe infections in the previous 48 hours
  • treatment with imipenem/cilastatin (recommended by hospital microbiologists)
  • expected duration of hospital stays in the ICU ≥ 72 h from recruitment
  • recruited patients agreed to participate in this trial, and had set up a signed informed consent

You may not qualify if:

  • with an allergy to carbapenems or with an adverse drug reaction to imipenem
  • acute or chronic renal failure assessed by serum creatinine concentrations \> 280 μmol/L (or creatinine clearance \<20mL/min) or those requiring continuous renal replacement therapy
  • drug or alcohol abuse
  • Pregnant and lactant women
  • patients near to death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kang Xu

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (1)

  • Huang Y, Xu K, Zhan Y, Zha X, Liu S, Xie J, Liu L, Li Q, Shao H, Yang Y. Comparable Effect of Two-Step Versus Extended Infusions on the Pharmacokinetics of Imipenem in Patients with Sepsis and Septic Shock. Adv Ther. 2020 May;37(5):2246-2255. doi: 10.1007/s12325-020-01339-5. Epub 2020 Apr 10.

    PMID: 32277344DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Imipenem

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThienamycinsCarbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Kang Xu, master

CONTACT

+8615851836872xukangyc@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director of the physician

Study Record Dates

First Submitted

November 13, 2015

First Posted

November 26, 2015

Study Start

January 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

November 26, 2015

Record last verified: 2015-11

Locations

CN(1)