The Pharmacodynamics of Doripenem Between 4-hour and 1-hour Infusion in Patients With Ventilator-associated Pneumonia
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Purpose
This is prospective and randomized study to assess the pharmacodynamics (t>MIC) of 0.5 g every 8 h of doripenem in patients with VAP following administration by a 4 h infusion or 1 h infusion.
Clinical and laboratory data such as Age,Sex, Body weight, Electrolyte, Vital signs, APACHE II score, BUN, Cr, Blood culture will be collected.
Twelve patients will be enrolled in this study. After completion of the doripenem therapy for 3 days in this study, all patients will receive other sensitive antibiotics to eradicate their bacterial infections.
Doripenem pharmacokinetic study will be carried out during the doripenem therapy. Blood samples (approximately 2 ml) in group " 0.5 g of doripenem with 4 h infusion every 8 h regimen" will be obtained by direct venepuncture at the following time: 0, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 8 h after 7th dose of doripenem.
Blood samples (approximately 2 ml) in group " 0.5 g of doripenem with 1 h infusion every 8 h regimen" will be obtained by direct venepuncture at the following time: 1, 1.5, 2, 4, 5, 6, 7 and 8 h after 7th dose of doripenem.
The doripenem assays by method of Ikeda K et al. (J Chromatogr B, 2008) will be performed.
Concentration of doripenem 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 Faction Response)
| Condition | Intervention | Phase |
|---|---|---|
|
Ventilator-Associated Pneumonia |
Drug: Doripenem |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | The Pharmacodynamics of Doripenem Between 4-hour and 1-hour Infusion in Patients With Ventilator-associated Pneumonia |
- Concentration of doripenem in plasma [ Time Frame: 8 hours profile after 7th dose of doripenem ] [ Designated as safety issue: No ]Concentration of doripenem 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 Faction Response).
| Enrollment: | 12 |
| Study Start Date: | October 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 0.5 g by 4 hour infusion
Blood samples (approximately 2 ml) in group " 0.5 g of doripenem with 4 h infusion every 8 h regimen" will be obtained by direct venepuncture at the following time: 0, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 8 h after 7th dose of doripenem.
|
Drug: Doripenem
(i) 0.5 g in 100 ml of normal saline solution and administered via an infusion pump at a constant flow rate over 1 h every 8 h. Blood samples (approximately 2 ml)will be obtained by direct venepuncture at the following time: 0, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 8 h after 7th dose of doripenem. Other Name: Doripenem (Doribax)
|
|
Experimental: 0.5 g by 1 hour infusion
Blood samples (approximately 2 ml) in group " 0.5 g of doripenem with 1 h infusion every 8 h regimen" will be obtained by direct venepuncture at the following time: 1, 1.5, 2, 4, 5, 6, 7 and 8 h after 7th dose of doripenem.
|
Drug: Doripenem
(ii) 0.5 g in 100 ml of normal saline solution and administered via an infusion pump at a constant flow rate over 1 h every 8 h. Blood samples (approximately 2 ml) will be obtained by direct venepuncture at the following time: 1, 1.5, 2, 4, 5, 6, 7 and 8 h after 7th dose of doripenem. Other Name: Doripenem (Doribax)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients aged ≥ 20 years
- Patients who have VAP with Gram negative bacilli infections. The diagnosis of VAP was 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; a leukocyte count higher than 10,000/mm3
Exclusion Criteria:
- Patients who have documented hypersensitivity to doripenem or other carbapenems.
- Patients who have an estimated creatinine clearance of ≤ 50 ml/min
- Patients who are in circulatory shock (defined as a systolic blood pressure of < 90 mmHg).
- Patients who are pregnant.
Contacts and Locations| Thailand | |
| Prince of Songkla University | |
| Hat Yai, Songkla, Thailand, 90110 | |
| 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: | NCT01467648 History of Changes |
| Other Study ID Numbers: | DORINOS4004 |
| Study First Received: | October 31, 2011 |
| Last Updated: | November 8, 2011 |
| Health Authority: | Thailand: Ethics Committee, Faculty of Medicine, Prince of Songkhla University |
Keywords provided by Prince of Songkla University:
|
Infection Doripenem Ventilator-Associated Pneumonia pharmacokinetic pharmacodynamic |
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 |
ClinicalTrials.gov processed this record on June 13, 2013