Trial record 4 of 125 for:
"Pneumonia, Ventilator-Associated"
The Population Pharmacokinetics of Imipenem in Patients With Ventilator-associated Pneumonia
This study has been completed.
Sponsor:
Sutep Jaruratanasirikul
Collaborator:
Prince of Songkla University
Information provided by (Responsible Party):
Sutep Jaruratanasirikul, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01489124
First received: November 23, 2011
Last updated: December 8, 2011
Last verified: December 2011
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Purpose
This is prospective, randomized and crossover design to assess the pharmacokinetic and pharmacodynamics of three regimen.
- 0.5-hr infusion of imipenem 0.5 g every 6 hrs
- 2-hr infusion of imipenem 0.5 g every 6 hrs
- 2-hr infusion of imipenem 1 g every 6 hrs
Clinical and laboratory data such as Age,Sex, Body weight, CBC, Electrolyte, Vital signs, APACHE II score, BUN, Cr, Sample and Blood culture will be collected.
Nine patients will be enrolled in this study. After completion of the imipenem therapy for 3 days in this study, all patients will receive other sensitive antibiotics to eradicate their bacterial infections.
Blood samples (approximately 3 ml) will be obtained by direct venepuncture at the following time: 0, 0.5, 1, 2, 3, 4, 5 and 6 after 4th dose of imipenem.
Concentration of imipenem in plasma will be measured by HPLC method. Then, the data will be simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to % PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response).
| Condition | Intervention | Phase |
|---|---|---|
|
Ventilator-Associated Pneumonia |
Drug: Imipenem |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | The Population Pharmacokinetics of Imipenem in Patients With Ventilator-associated Pneumonia |
Resource links provided by NLM:
Further study details as provided by Prince of Songkla University:
Primary Outcome Measures:
- Efficacy of imipenem administration by a 0.5 h and 2 h infusion [ Time Frame: At 0, 0.5, 1, 2, 3, 4, 5 and 6 hours after 4th dose of imipenem. ] [ Designated as safety issue: No ]Concentration of imipenem in plasma will be simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to % PTA (Probability Target Attainment) and %CFR (Cumulative Fraction Response).
| Enrollment: | 9 |
| Study Start Date: | January 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 0.5 g of imipenem by 0.5-hr infusion
0.5 g of imipenem every 6 hrs administrated by 0.5-hr infusion for 3 days
|
Drug: Imipenem
0.5 g of imipenem every 6 hrs administrated by 0.5-hr infusion for 3 days
Other Name: Imipenem (Tienam)
|
|
Experimental: 0.5 g of imipenem by 2-hr infusion
0.5 g of imipenem every 6 hrs administrated by 2-hr infusion for 3 days
|
Drug: Imipenem
0.5 g of imipenem every 6 hrs administrated by 2-hr infusion for 3 days
Other Name: Imipenem (Tienam)
|
|
Experimental: 1 g of imipenem by 2-hr infusion
1 g of imipenem every 6 hrs administrated by 2-hr infusion for 3 days
|
Drug: Imipenem
1 g of imipenem every 6 hrs administrated by 2-hr infusion for 3 days
Other Name: Imipenem (Tienam)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients aged ≥ 18 years
- Patients are intubated and receiving mechanical ventilation.
- Patients have clinical suspicion of VAP with Gram negative bacilli infections, defined by a new and persistent infiltrate on chest radiography associated with at least one of the following: purulent tracheal secretions, temperature of 38.3°C or higher or a leucocyte count higher than 10000 cells/mm3.
- Expected life expectancy ≥ 3 days
Exclusion Criteria:
- Patients have documented hypersensitivity to imipenem or other carbapenems.
- Patients have an estimated creatinine clearance < 60 ml/min
- Patients are in circulatory shock (defined as a systolic blood pressure of < 90 mmHg).
- Patients are pregnant.
- Pretient receive imipenem for 2 weeks before randomization.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489124
Locations
| Thailand | |
| Prince of Songkla University | |
| Hat Yai, Songkla, Thailand, 90110 | |
Sponsors and Collaborators
Sutep Jaruratanasirikul
Prince of Songkla University
Investigators
| Principal Investigator: | Sutep Jaruratanasirikul, MD | Prince of Songkha |
More Information
No publications provided
| Responsible Party: | Sutep Jaruratanasirikul, Principal Investigator, Prince of Songkla University |
| ClinicalTrials.gov Identifier: | NCT01489124 History of Changes |
| Other Study ID Numbers: | IMI-50-372-028 |
| Study First Received: | November 23, 2011 |
| Last Updated: | December 8, 2011 |
| Health Authority: | Thailand: Ethics Committee, Faculty of Medicine, Prince of Songkhla University |
Keywords provided by Prince of Songkla University:
|
Infection Imipenem Ventilator-Associated Pneumonia pharmacokinetic pharmacodynamic |
Additional relevant MeSH terms:
|
Pneumonia, Ventilator-Associated Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Cross Infection Infection |
Ventilator-Induced Lung Injury Lung Injury Imipenem Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013