Pharmacodynamics Study of Imipenem in Patients With Ventilator Associated Pneumonia
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Purpose
Imipenem is a carbapenem antibacterial agent with a broad spectrum of activity against Gram-negative and Gram-positive bacteria. This agent is often used as the last line of therapy for highly resistant Gram negative bacilli nosocomial infections. In common with other beta-lactamase inhibitor, the main pharmacokinetic/pharmacodynamic (PK/PD) index that correlates with the therapeutic efficacy is the time that concentrations in the tissue and serum are above the MIC and administration by continuous infusion is the preferred mode of administration to maximize this parameter.
However, in tropical countries, the stability of carbapenem antibiotics is an important consideration when considering continuous infusion. Therefore, prolonged infusion may be a useful mode of administration to maximize bactericidal activity. This study will demonstrate the stability of imipenem in clinical use at room temperature in tropical countries.
| Condition | Intervention | Phase |
|---|---|---|
|
Ventilator Associated Pneumonia |
Drug: Imipenem |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Pharmacodynamics of Imipenem in Critically Ill Patients With Ventilator-associated Pneumonia Following Administration by 4 h or 0.5 h Infusion |
- Accessed PK/PD parameters [ Time Frame: 24 hours profile after first dose of trail drug. ] [ Designated as safety issue: No ]
- To determine plasma Imipenem PK/PD parameters (the PK/PD index (T>MIC), the probability of target attainment (PTA) at 40% (T>MIC), the cumulative fraction of response (CFR))after 4 hr infusion of 1 gm every 8 hr compared to 0.5 hr infusion of 0.5 gm every 6 hr.
Conventional arm: after first dose, blood samples will be obtained by direct venepuncture at: time 0, 0.5, 6, 6.5, 12, 12.5, 18, 18.25, 18.5, 18.75, 20, 21, 22 and 24 hr Extended infusion arm: after first dose, blood samples will be obtained by direct venepuncture at: time 0, 4, 8, 12, 16, 16.5, 17, 18, 20, 20.5, 21, 22, and 24 hr
| Estimated Enrollment: | 12 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Conventional arm
Infusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 3-5 days
|
Drug: Imipenem
Each patient will receive a loading dose of 0.5 g 3 min infusion followed by 0.5 hr infusion of 0.5 g every 6 hr of imipenem at room temperature
Other Name: Tienam
|
|
Experimental: Extended infusion arm
Infusion of 1 g of imipenem for 4 hr every 8 hr for 3-5 days
|
Drug: Imipenem
Each patient will receive a loading dose of 0.5 g 3 min infusion followed by 4 hr infusion of 1 g every 8 hr of imipenem at room temperature
Other Name: Tienam
|
Eligibility| Ages Eligible for Study: | 20 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients aged > or = 20 years
- Patients who have VAP with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion
Exclusion Criteria:
- Patients who have documented hypersensitivity to imipenem or other carbapenems
- Patients who have an estimated creatinine clearance of < or = 60 ml/min
- Patients who are in circulatory shock
- Patients who are pregnant
Contacts and Locations| Contact: Sutep Jaruratanasirikul, M.D. | 6674281485 | jasutep@medicine.psu.ac.th |
| Thailand | |
| Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University | Recruiting |
| Hat Yai, Songkla, Thailand, 90110 | |
More Information
No publications provided
| Responsible Party: | Sutep Jaruratanasirikul, Prof.Dr.Sutep Jaruratanasirikul, Prince of Songkla University |
| ClinicalTrials.gov Identifier: | NCT01379157 History of Changes |
| Other Study ID Numbers: | MISP 39337 |
| Study First Received: | May 5, 2011 |
| Last Updated: | December 27, 2011 |
| Health Authority: | Thailand: Ethics Committee Faculty of Medicine, Prince of Songkhla University |
Keywords provided by Prince of Songkla University:
|
Patients with ventilator-associated pneumonia |
Additional relevant MeSH terms:
|
Pneumonia Pneumonia, Ventilator-Associated 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 May 23, 2013