Lower Respiratory Tract InfectionPhase 4NCT01944319
Meropenem Dosage Strategy Based on PPK Model
A Phase 4 study testing Routine meropenem therapy and Meropenem therapy based on a PPK and PD model in people with Lower Respiratory Tract Infection, run by Qingtao Zhou at 1 site in China.
Trial summary
To evaluate the clinical and economical benefits of a meropenem dosage strategy based on a population pharmacokinetic(PPK)-pharmacodynamic(PD) model in lower respiratory tract infection patients. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Lower Respiratory Tract Infection
- What is being tested?
- Routine meropenem therapy and Meropenem therapy based on a PPK and PD model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Oct 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sixty years and older patients hospitalized at the Peking University Third Hospital with community-acquired or hospital-acquired lower respiratory tract infection.
- Bacilli was idolated from lower respiratory tract specimens within 48 hours prior to study enrollment.
- The pathogen was sensitive to meropenem.
- Received broad-spectrum antibiotic therapy less than 24 hours, or no improvement after antibiotic therapy and pathogen was resistant to the used antibiotics.
Who cannot join
- Had documented hypersensitivity to carbapenems.
- More than one pathogenic Gram-negative bacillus was isolated lower respiratory tract specimens.
- Positive HIV antibody titre.
- Had known or suspected tuberculosis or other infections caused by Gram-positive cocci, viruses or fungi at baseline.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospita
Haidian District, Beijing Municipality, 100191
About this study
Official title: Clinical Evaluation of a Meropenem Dosage Strategy Based on a Population Pharmacokinetic-pharmacodynamic Model in Lower Respiratory Tract Infection Patients
To evaluate the clinical and economical benefits of a meropenem dosage strategy based on a population pharmacokinetic(PPK)-pharmacodynamic(PD) model in lower respiratory tract infection patients.
Read the detailed description
- Subjects:lower respiratory tract infection patients
- Study design:randomized control study.The patients in study group will accept meropenem therapy with the regimen decided by a software developed from a PPK-PD model. The patients in control group will accept meropenem therapy with the regimen decided by attending physician.
- Primary endpoint: clinical successful rate of meropenem therapy. The clinical efficiency of meropenem therapy will be evaluated one week later from stop of meropenem therapy.
- Second endpoint: amount of used antibiotics and bacteriological successful rate.
- Conditions
- Lower Respiratory Tract Infection
- Being tested
- Routine meropenem therapy, Meropenem therapy based on a PPK and PD model
- Keywords
- Infection; Meropenem; Pharmacokinetics; Pharmacodynamics
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine meropenem therapyDrug
Also called Standard care
Participants in control group will accept meropenem therapy with regimen routinely decided by attending physician
Meropenem therapy based on a PPK and PD modelDrug
Also called Experimental meropenem therapy
Participants in study group will accept meropenem therapy based on a software developed from a PPK and PD model
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The participants in control group will accept routine meropenem therapy Receives: Drug: Routine meropenem therapy |
| Study group | Experimental | The participants in study group will accept meropenem therapy based on a PPK and PD model. Receives: Drug: Meropenem therapy based on a PPK and PD model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success Rate
The clinical success or failure of meropenem therapy will be evaluated one week after stop of antibiotic therapy.
Clinical success was defined as cure or improvement of all signs and symptoms caused by the infection and no requirement for additional antibacterial therapy.
Clinical failure was defined as a persistence or worsening of any new clinical sign or symptom, development of any new clinical signs or symptoms of infection, or the requirement for other systemic antimicrobial therapy at the end of meropenem therapy.
Measured: One week after antibiotic therapy finished.
Secondary outcomes (2)
Amount of Used Antibiotics
Record the amount of antibiotics usage during antibiotic therapy
Measured: participants will be followed for the duration of antibiotic therapy, an average of 10 days
Bacteriological Success Rate
The bacterial success or failure will be evaluated at the end of meropenem therapy.
Bacteriological success including eradication and presumed eradication. Bacteriological failure including persistence and presumed persistence.
Measured: At the end of meropenem therapy, an average of 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Respiratory Tract InfectionStudies 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qingtao Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qingtao Zhou, Peking University Third Hospital
- Investigators
- Qingtao Zhou, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944319
- Sponsor's protocol ID
- 75505-01
- Status last verified
- Jan 2016
- First submitted
- 2 Jul 2013
- Last updated
- 25 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zhou QT, He B, Shen N, Liang Y, Sun LN. Meropenem Dosing Based on a Population Pharmacokinetic-Pharmacodynamic Model in Elderly Patients with Infection of the Lower Respiratory Tract. Drugs Aging. 2017 Feb;34(2):115-121. doi: 10.1007/s40266-016-0431-9.
PubMed 28097633
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Meropenem Dosage Strategy Based on a Population Pharmacokinetic-pharmacodynamic Model in Lower Respiratory Tract Infection Patients
- ClinicalTrials.gov ID
- NCT01944319
- Acronym / sponsor ID
- 75505-01
- Conditions
- Lower Respiratory Tract Infection
- Keywords
- Infection; Meropenem; Pharmacokinetics; Pharmacodynamics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Qingtao ZhouUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Posted 25 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the clinical and economical benefits of a meropenem dosage strategy based on a population pharmacokinetic(PPK)-pharmacodynamic(PD) model in lower respiratory tract infection patients.
Detailed description
- Subjects:lower respiratory tract infection patients
- Study design:randomized control study.The patients in study group will accept meropenem therapy with the regimen decided by a software developed from a PPK-PD model. The patients in control group will accept meropenem therapy with the regimen decided by attending physician.
- Primary endpoint: clinical successful rate of meropenem therapy. The clinical efficiency of meropenem therapy will be evaluated one week later from stop of meropenem therapy.
- Second endpoint: amount of used antibiotics and bacteriological successful rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Routine meropenem therapyThe participants in control group will accept routine meropenem therapy |
| Study group | Experimental | Drug: Meropenem therapy based on a PPK and PD modelThe participants in study group will accept meropenem therapy based on a PPK and PD model. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sixty years and older patients hospitalized at the Peking University Third Hospital with community-acquired or hospital-acquired lower respiratory tract infection.
- Bacilli was idolated from lower respiratory tract specimens within 48 hours prior to study enrollment.
- The pathogen was sensitive to meropenem.
- Received broad-spectrum antibiotic therapy less than 24 hours, or no improvement after antibiotic therapy and pathogen was resistant to the used antibiotics.
Key exclusion criteria (4 listed)
- Had documented hypersensitivity to carbapenems.
- More than one pathogenic Gram-negative bacillus was isolated lower respiratory tract specimens.
- Positive HIV antibody titre.
- Had known or suspected tuberculosis or other infections caused by Gram-positive cocci, viruses or fungi at baseline.
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 |
|---|---|---|
| Routine meropenem therapyAlso: Standard careParticipants in control group will accept meropenem therapy with regimen routinely decided by attending physician | Drug | Control group |
| Meropenem therapy based on a PPK and PD modelAlso: Experimental meropenem therapyParticipants in study group will accept meropenem therapy based on a software developed from a PPK and PD model | Drug | Study group |
Primary outcome
Clinical Success Rate
Time frame: One week after antibiotic therapy finished.
The clinical success or failure of meropenem therapy will be evaluated one week after stop of antibiotic therapy. Clinical success was defined as cure or improvement of all signs and symptoms caused by the infection and no requirement for additional antibacterial therapy. Clinical failure was defined as a persistence or worsening of any new clinical sign or symptom, development of any new clinical signs or symptoms of infection, or the requirement for other systemic antimicrobial therapy at the end of meropenem therapy.
2 secondary outcomes
Amount of Used Antibiotics
Time frame: participants will be followed for the duration of antibiotic therapy, an average of 10 days
Bacteriological Success Rate
Time frame: At the end of meropenem therapy, an average of 10 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28097633Zhou QT, He B, Shen N, Liang Y, Sun LN. Meropenem Dosing Based on a Population Pharmacokinetic-Pharmacodynamic Model in Elderly Patients with Infection of the Lower Respiratory Tract. Drugs Aging. 2017 Feb;34(2):115-121. doi: 10.1007/s40266-016-0431-9.
- Individual participant dataSharing planned: No
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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.
Qingtao Zhou, M.D. principal investigator
Peking University Third Hospital
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 Routine meropenem therapy and Meropenem therapy based on a PPK and PD model in people with Lower Respiratory Tract Infection, run by Qingtao Zhou at 1 site in China.
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 4 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 25 Feb 2016. 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 China. 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?
Yes. Results are posted in the registry (first posted 25 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Success Rate (time frame: One week after antibiotic therapy finished.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01944319, which also lists 1 linked publication.
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 25 Feb 2016.