Ventilator Associated PneumoniaPhase 4NCT01379157
Pharmacodynamics Study of Imipenem in Patients With Ventilator Associated Pneumonia
A Phase 4 study testing Imipenem in people with Ventilator Associated Pneumonia, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Imipenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2011to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged > or = 20 years
- Patients who have VAP with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: The Pharmacodynamics of Imipenem in Critically Ill Patients With Ventilator-associated Pneumonia Following Administration by 4 h or 0.5 h Infusion
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.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Imipenem
- Keywords
- Patients with ventilator-associated pneumonia
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImipenemDrug
Also called Tienam
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
ImipenemDrug
Also called Tienam
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
| Study group | Role | What they receive |
|---|---|---|
| Conventional arm | Active comparator | Infusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 3-5 days Receives: Drug: Imipenem |
| Extended infusion arm | Experimental | Infusion of 1 g of imipenem for 4 hr every 8 hr for 3-5 days Receives: Drug: Imipenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accessed PK/PD parameters
- 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
Measured: 24 hours profile after first dose of trail drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Sutep Jaruratanasirikul, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379157
- Sponsor's protocol ID
- MISP 39337
- Status last verified
- Dec 2011
- First submitted
- 5 May 2011
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacodynamics of Imipenem in Critically Ill Patients With Ventilator-associated Pneumonia Following Administration by 4 h or 0.5 h Infusion
- ClinicalTrials.gov ID
- NCT01379157
- Acronym / sponsor ID
- MISP 39337
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Patients with ventilator-associated pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Nov 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional arm | Active comparator | Drug: ImipenemInfusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 3-5 days |
| Extended infusion arm | Experimental | Drug: ImipenemInfusion of 1 g of imipenem for 4 hr every 8 hr for 3-5 days |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged > or = 20 years
- Patients who have VAP with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImipenemAlso: TienamEach 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 | Drug | Conventional arm |
| ImipenemAlso: TienamEach 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 | Drug | Extended infusion arm |
Primary outcome
Accessed PK/PD parameters
Time frame: 24 hours profile after first dose of trail drug.
- 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Imipenem in people with Ventilator Associated Pneumonia, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accessed PK/PD parameters (time frame: 24 hours profile after first dose of trail drug.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2017.