Patients With Febrile NeutropeniaPhase 4NCT02213783
Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia
A Phase 4 study testing Imipenem in people with Patients With Febrile Neutropenia, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
This is prospective and randomized study to compare the pharmacodynamics (t>MIC) of 0.5 g every 6 h of imipenem in twelve patients with febrile neutropenia following administration by a 4 h infusion or bolus injection. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Patients With Febrile Neutropenia
- 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
- 12 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2011to Sep 2013
- 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 febrile neutropenia with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion
- Patients who are likely to survive 3 days
Who cannot join
- Patients who have documented hypersensitivity to imipenem or other carbapenems
- Patients who have an estimated creatinine clearance of < 50 ml/min
- Patients who are in circulatory shock or hypotension (systolic < 90 mmHg)
- 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: Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia Following Administration by 4-hour Infusion and Bolus Injection.
This is prospective and randomized study to compare the pharmacodynamics (t>MIC) of 0.5 g every 6 h of imipenem in twelve patients with febrile neutropenia following administration by a 4 h infusion or bolus injection.
Concentration of imipenem in plasma will be measured by HPLC method and 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.
- Conditions
- Patients With Febrile Neutropenia
- Being tested
- Imipenem
- Keywords
- Imipenem, Febrile neutropenia, Gram-negative infection, Pharmacodynamic, Monte Carlo Simulation
- Medical subject headings
- Febrile Neutropenia
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 0.5 g of imipenem, 0.5 hr infusion every 6 hr at room temperature
ImipenemDrug
Also called Tienam
Each patient will receive 0.5 g of imipenem, 4 hr infusion every 6 hr of 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 2-5 days Receives: Drug: Imipenem |
| Extended infusion arm | Experimental | Infusion of 0.5 g of imipenem for 4 hr every 6 hr for 2-5 days Receives: Drug: Imipenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of imipenem in plasma
Concentration of imipenem in plasma will be determined by HPLC method and 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).
Measured: 6 hours profile after 8th dose of imipenem
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startFeb 2011
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Febrile NeutropeniaStudies 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
- 12 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
- Investigators
- Sutep Jaruratanasirikul, M.D., Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213783
- Sponsor's protocol ID
- IMIFN53-068-11-1-1
- Status last verified
- Aug 2014
- First submitted
- 8 Aug 2014
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia Following Administration by 4-hour Infusion and Bolus Injection.
- ClinicalTrials.gov ID
- NCT02213783
- Acronym / sponsor ID
- IMIFN53-068-11-1-1
- Conditions
- Patients With Febrile Neutropenia
- Keywords
- Imipenem, Febrile neutropenia, Gram-negative infection, Pharmacodynamic, Monte Carlo Simulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 Aug 2014 (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.
This is prospective and randomized study to compare the pharmacodynamics (t>MIC) of 0.5 g every 6 h of imipenem in twelve patients with febrile neutropenia following administration by a 4 h infusion or bolus injection.
Concentration of imipenem in plasma will be measured by HPLC method and 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.
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 2-5 days |
| Extended infusion arm | Experimental | Drug: ImipenemInfusion of 0.5 g of imipenem for 4 hr every 6 hr for 2-5 days |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged > or = 20 years
- Patients who have febrile neutropenia with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion
- Patients who are likely to survive 3 days
Key exclusion criteria (4 listed)
- Patients who have documented hypersensitivity to imipenem or other carbapenems
- Patients who have an estimated creatinine clearance of < 50 ml/min
- Patients who are in circulatory shock or hypotension (systolic < 90 mmHg)
- 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 0.5 g of imipenem, 0.5 hr infusion every 6 hr at room temperature | Drug | Conventional arm |
| ImipenemAlso: TienamEach patient will receive 0.5 g of imipenem, 4 hr infusion every 6 hr of at room temperature | Drug | Extended infusion arm |
Primary outcome
Concentration of imipenem in plasma
Time frame: 6 hours profile after 8th dose of imipenem
Concentration of imipenem in plasma will be determined by HPLC method and 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).
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 11 Aug 2014.
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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.
Sutep Jaruratanasirikul, M.D. principal investigator
Prince of Songkla University
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 Patients With Febrile Neutropenia, 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 3 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 11 Aug 2014. 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?
Concentration of imipenem in plasma (time frame: 6 hours profile after 8th dose of imipenem). 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 11 Aug 2014.