search
Back to results

Preliminary Research On Two-step Dosing Of Imipenem/Cilastatin (PROTDOI)

Primary Purpose

Sepsis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Imipenem
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Pharmacokinetics; pharmacodynamic; imipenem; sepsis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Kang XuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group I

Group II

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Area under the plasma concentration versus time curve (AUC)

Secondary Outcome Measures

Plasma Concentration
immediately prior to imipenem/cilastatin administration (time 0 min) and at 30 min, 1h, 2h, 4h, 6h and 8h after administration of the infusion

Full Information

First Posted
November 13, 2015
Last Updated
November 24, 2015
Sponsor
Southeast University, China
Collaborators
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT02616354
Brief Title
Preliminary Research On Two-step Dosing Of Imipenem/Cilastatin
Acronym
PROTDOI
Official Title
Preliminary Research On Two-step Dosing Of Imipenem/Cilastatin
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Compared with Imipenem/Cilastatin 2 hours continuous dosing method and two-step dosing method (0.5 hours before enter half dose, after 1.5 hours, the other half of the input dose) of blood drug concentration in the body than the minimal inhibitory concentrations (MIC) pathogens percent of dosing interval duration (100% fT > MIC), blood drug concentration in the body more than 4 times the minimal inhibitory concentrations (MIC) pathogens percent of dosing interval duration (100% fT > 4 MIC), blood drug concentration peak and the ratio of the minimal inhibitory concentrations (MIC) pathogens (Cmax/MIC), blood drug concentration (Tmax) used in the peak time, used to guide clinical patients with severe infection of Imipenem/Cilastatin usage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Pharmacokinetics; pharmacodynamic; imipenem; sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Group II
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Imipenem
Other Intervention Name(s)
Optimized two-step infusion therapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC)
Time Frame
up to 9 months
Secondary Outcome Measure Information:
Title
Plasma Concentration
Description
immediately prior to imipenem/cilastatin administration (time 0 min) and at 30 min, 1h, 2h, 4h, 6h and 8h after administration of the infusion
Time Frame
up to 9 months
Other Pre-specified Outcome Measures:
Title
PK/PD indices
Description
Time>MIC (∫T>MIC) and 4×MIC (∫T>4×MIC)
Time Frame
up to 9 moths

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kang Xu, master
Phone
+8615851836872
Email
xukangyc@163.com
Facility Information:
Facility Name
Kang Xu
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kang Xu
Phone
+86 15851836872
Email
xukangyc@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32277344
Citation
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.
Results Reference
derived

Learn more about this trial

Preliminary Research On Two-step Dosing Of Imipenem/Cilastatin

We'll reach out to this number within 24 hrs