PneumoniaPhase 1NCT03177720
Evaluation of Innovative Tools in Development of Antibiotics
A Phase 1 study testing Ciprofloxacin and Imipenem in people with Pneumonia, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The investigators will determine the difference of pharmacokinetics of ciprofloxacin and imipenem between healthy volunteers and intensive care patients suffering from pneumonia in plasma and at the target site - lung - using bronchoalveolar lavage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia
- What is being tested?
- Ciprofloxacin and Imipenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- 29 May 2016to 31 Jul 2021
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male subjects aged 18 to 55 years
- Good state of health (mentally and physically)
- Body mass index within a range of 18 to 28kg/m2 inclusive.
- Non-Smoker
- A signed and dated written informed consent form.
- The subject is able to understand and willing to comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
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- Negative serology (human immunodeficiency virus, hepatitis B-AG and C-AB) at screening.
- Vital signs should be within the following ranges:
- Oral or tympanic temperature between 35 and 37.5°C.
- Systolic blood pressure, 90-140 mmHg.
- Diastolic blood pressure, 50-90 mmHg.
- Pulse rate, 50-90 bpm.
Who cannot join
- Any acute or chronic illness or clinically relevant (Investigator's judgement) abnormality identified on the screening medical assessment, laboratory tests or ECG, unless in the opinion of the Investigator it will not interfere with the study procedures, affect the outcome of the study or compromise the safety of the subject.
- All subjects with known seizure disorder, with the exception of a febrile seizure in childhood
- Use of prescription or non-prescription drugs within 7 days or 10 times the elimination half-life (whichever is longer) prior to the first dose of study medication.
- Any intake of grapefruit juice within 1 week prior to the first dose.
- Allergies (except for mild forms of hay fever), a history of hypersensitivity reactions including psychological or neurological symptoms or signs, or anaphylactic shock following administration of any medicine.
- Allergy to or any contraindication against the active or inactive ingredients in the study medication (ciprofloxacin, imipenem, cilastatin, propofol, midazolam, remifentanil, xylocain, and sevoflurane) and radioactive labelling with 14C.
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- Smoker
- Alcohol or drug abuse
- Participation in a trial with any drug within 30 days or five half-lives (whichever is longer) before the start of the study.
- Donation of blood within a period of 4 weeks prior to dosing.
- Creatinine clearance ≤70mL/min/1.73m3
- Any other reason that the Investigator considers to make the subject unsuitable to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Single-dose Intrapulmonary Pharmacokinetics of Ciprofloxacin and Imipenem in Healthy Subjects and Intubated Patients Suffering From Pneumonia Using Bronchoalveolar Lavage
The investigators will determine the difference of pharmacokinetics of ciprofloxacin and imipenem between healthy volunteers and intensive care patients suffering from pneumonia in plasma and at the target site - lung - using bronchoalveolar lavage. As additional aspect the feasibility of combining microdosing of C14 ciprofloxacin with microdialysis, saliva sampling and bronchoalveolar lavage is studied by comparing pharmacokinetics of microdose and macrodose.
- Conditions
- Pneumonia
- Being tested
- Ciprofloxacin, Imipenem
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
Ciprofloxacin 400mg will be administered as single dose infusion over 60 minutes, imipenem/cilastatin 1000mg as single intravenous dose applicated over 60 minutes.
ImipenemDrug
Ciprofloxacin 400mg will be administered as single dose infusion over 60 minutes, imipenem/cilastatin 1000mg as single intravenous dose applicated over 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin | Active comparator | Half of patients and healthy volunteers are receiving ciprofloxacin, the other half imipenem. Receives: Drug: Ciprofloxacin |
| Imipenem | Active comparator | Half of patients and healthy volunteers are receiving ciprofloxacin, the other half imipenem. Receives: Drug: Imipenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (peak concentration in plasma and epithelial lining fluid) of imipenem and ciprofloxacin
Comparison of Cmax of ciprofloxacin and imipenem in plasma and epithelial lining fluid, alveolar macrophages and saliva (only healthy subjects) in healthy subjects and patients with bacterial pneumonia.
Measured: Plasma over 10 hours and BAL (bronchoalveolar lavage) Sampling at different time points in these 10 hours.
AUC (area under the concentration curve in plasma and epithelial lining fluid) of imipenem and ciprofloxacin.
Comparison of AUC of ciprofloxacin and imipenem in plasma and epithelial lining fluid, alveolar macrophages and saliva (only healthy subjects) in healthy subjects and patients with bacterial pneumonia.
Measured: Plasma over 10 hours and BAL Sampling at different time points in these 10 hours.
Tmax (time of peak concentration in plasma and epithelial lining fluid) of imipenem and ciprofloxacin.
Comparison of AUC of ciprofloxacin and imipenem in plasma and epithelial lining fluid, alveolar macrophages and saliva (only healthy subjects) in healthy subjects and patients with bacterial pneumonia.
Measured: Plasma over 10 hours and BAL Sampling at different time points in these 10 hours.
Cmax (peak concentration in plasma, epithelial lining fluid and microdialysate) of C14 ciprofloxacin (microdose)
Comparison of pharmacokinetics of microdoses and macrodoses in lung, subcutaneous tissue (microdialysis) and plasma in healthy volunteers.
Measured: Plasma sampling over 10 hours and microdialysate sampling.
AUC (area under the curve in plasma, epithelial lining fluid and microdialysate) of C14 ciprofloxacin (carbon-14 radiolabelled compound, microdose)
Comparison of pharmacokinetics of microdoses and macrodoses in lung, subcutaneous tissue (microdialysis) and plasma in healthy volunteers.
Measured: Plasma sampling over 10 hours and microdialysate sampling.
Tmax (time of peak concentration in plasma, epithelial lining fluid and microdialysate) of C14 ciprofloxacin (microdose)
Comparison of pharmacokinetics of microdoses and macrodoses in lung, subcutaneous tissue (microdialysis) and plasma in healthy volunteers.
Measured: Plasma sampling over 10 hours and microdialysate sampling.
Cmax (peak concentration in microdialysate) of ciprofloxacin (macrodose)
In healthy volunteers only for comparison of Cmax of C14 ciprofloxacin and Cmax of ciprofloxacin as macrodose.
Measured: Microdialysate sampling (Baseline sampling before study drug administration - sampling over 3 hours - retrodialysis)
AUC (area under the concentration curve in microdialysate) of ciprofloxacin (macrodose)
In healthy volunteers only for comparison of Cmax of C14 ciprofloxacin and Cmax of ciprofloxacin as macrodose.
Measured: Microdialysate sampling (Baseline sampling before study drug administration - sampling over 3 hours - retrodialysis)
Tmax (time of peak concentration in microdialysate) of ciprofloxacin (macrodose)
In healthy volunteers only for comparison of Cmax of C14 ciprofloxacin and Cmax of ciprofloxacin as macrodose.
Measured: Microdialysate sampling (Baseline sampling before study drug administration - sampling over 3 hours - retrodialysis)
Secondary outcomes (1)
Incidence of Treatment Emergent Adverse Events
Incidence of Treatment Emergent Adverse Events (Study drugs: ciprofloxacin, 14C labelled ciprofloxacin and imipenem)
Measured: Screening visit and final examination are performed up to 7 days before/after the actual study day and safety and tolerability assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start29 May 2016
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 24 patients and 18 healthy volunteers are included. 12 patients and 9 volunteers are receiving imipenem as study drug, the other 12 patients and 9 volunteers receive ciprofloxacin.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Zeitlinger, Medical University of Vienna
- Investigators
- Markus Zeitlinger, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177720
- Sponsor's protocol ID
- ELF Cipro
- Status last verified
- Aug 2021
- First submitted
- 30 May 2017
- Last updated
- 1 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Oesterreicher Z, Eberl S, Wulkersdorfer B, Matzneller P, Eder C, van Duijn E, Vaes WHJ, Reiter B, Stimpfl T, Jager W, Nussbaumer-Proell A, Marhofer D, Marhofer P, Langer O, Zeitlinger M. Microdosing as a Potential Tool to Enhance Clinical Development of Novel Antibiotics: A Tissue and Plasma PK Feasibility Study with Ciprofloxacin. Clin Pharmacokinet. 2022 May;61(5):697-707. doi: 10.1007/s40262-021-01091-1. Epub 2022 Jan 7.
PubMed 34997559
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Single-dose Intrapulmonary Pharmacokinetics of Ciprofloxacin and Imipenem in Healthy Subjects and Intubated Patients Suffering From Pneumonia Using Bronchoalveolar Lavage
- ClinicalTrials.gov ID
- NCT03177720
- Acronym / sponsor ID
- ELF Cipro
- Conditions
- Pneumonia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 29 May 2016 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 6 Jun 2017 (actual)
- 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.
The investigators will determine the difference of pharmacokinetics of ciprofloxacin and imipenem between healthy volunteers and intensive care patients suffering from pneumonia in plasma and at the target site - lung - using bronchoalveolar lavage. As additional aspect the feasibility of combining microdosing of C14 ciprofloxacin with microdialysis, saliva sampling and bronchoalveolar lavage is studied by comparing pharmacokinetics of microdose and macrodose.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 24 patients and 18 healthy volunteers are included. 12 patients and 9 volunteers are receiving imipenem as study drug, the other 12 patients and 9 volunteers receive ciprofloxacin.
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin | Active comparator | Drug: CiprofloxacinHalf of patients and healthy volunteers are receiving ciprofloxacin, the other half imipenem. |
| Imipenem | Active comparator | Drug: ImipenemHalf of patients and healthy volunteers are receiving ciprofloxacin, the other half imipenem. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy male subjects aged 18 to 55 years
- Good state of health (mentally and physically)
- Body mass index within a range of 18 to 28kg/m2 inclusive.
- Non-Smoker
- A signed and dated written informed consent form.
Key exclusion criteria (12 listed)
- Any acute or chronic illness or clinically relevant (Investigator's judgement) abnormality identified on the screening medical assessment, laboratory tests or ECG, unless in the opinion of the Investigator it will not interfere with the study procedures, affect the outcome of the study or compromise the safety of the subject.
- All subjects with known seizure disorder, with the exception of a febrile seizure in childhood
- Use of prescription or non-prescription drugs within 7 days or 10 times the elimination half-life (whichever is longer) prior to the first dose of study medication.
- Any intake of grapefruit juice within 1 week prior to the first dose.
- Allergies (except for mild forms of hay fever), a history of hypersensitivity reactions including psychological or neurological symptoms or signs, or anaphylactic shock following administration of any medicine.
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 |
|---|---|---|
| CiprofloxacinCiprofloxacin 400mg will be administered as single dose infusion over 60 minutes, imipenem/cilastatin 1000mg as single intravenous dose applicated over 60 minutes. | Drug | Ciprofloxacin |
| ImipenemCiprofloxacin 400mg will be administered as single dose infusion over 60 minutes, imipenem/cilastatin 1000mg as single intravenous dose applicated over 60 minutes. | Drug | Imipenem |
Primary outcome
Cmax (peak concentration in plasma and epithelial lining fluid) of imipenem and ciprofloxacin
Time frame: Plasma over 10 hours and BAL (bronchoalveolar lavage) Sampling at different time points in these 10 hours.
Comparison of Cmax of ciprofloxacin and imipenem in plasma and epithelial lining fluid, alveolar macrophages and saliva (only healthy subjects) in healthy subjects and patients with bacterial pneumonia.
AUC (area under the concentration curve in plasma and epithelial lining fluid) of imipenem and ciprofloxacin.
Time frame: Plasma over 10 hours and BAL Sampling at different time points in these 10 hours.
Comparison of AUC of ciprofloxacin and imipenem in plasma and epithelial lining fluid, alveolar macrophages and saliva (only healthy subjects) in healthy subjects and patients with bacterial pneumonia.
Tmax (time of peak concentration in plasma and epithelial lining fluid) of imipenem and ciprofloxacin.
Time frame: Plasma over 10 hours and BAL Sampling at different time points in these 10 hours.
Comparison of AUC of ciprofloxacin and imipenem in plasma and epithelial lining fluid, alveolar macrophages and saliva (only healthy subjects) in healthy subjects and patients with bacterial pneumonia.
Cmax (peak concentration in plasma, epithelial lining fluid and microdialysate) of C14 ciprofloxacin (microdose)
Time frame: Plasma sampling over 10 hours and microdialysate sampling.
Comparison of pharmacokinetics of microdoses and macrodoses in lung, subcutaneous tissue (microdialysis) and plasma in healthy volunteers.
AUC (area under the curve in plasma, epithelial lining fluid and microdialysate) of C14 ciprofloxacin (carbon-14 radiolabelled compound, microdose)
Time frame: Plasma sampling over 10 hours and microdialysate sampling.
Comparison of pharmacokinetics of microdoses and macrodoses in lung, subcutaneous tissue (microdialysis) and plasma in healthy volunteers.
Tmax (time of peak concentration in plasma, epithelial lining fluid and microdialysate) of C14 ciprofloxacin (microdose)
Time frame: Plasma sampling over 10 hours and microdialysate sampling.
Comparison of pharmacokinetics of microdoses and macrodoses in lung, subcutaneous tissue (microdialysis) and plasma in healthy volunteers.
Cmax (peak concentration in microdialysate) of ciprofloxacin (macrodose)
Time frame: Microdialysate sampling (Baseline sampling before study drug administration - sampling over 3 hours - retrodialysis)
In healthy volunteers only for comparison of Cmax of C14 ciprofloxacin and Cmax of ciprofloxacin as macrodose.
AUC (area under the concentration curve in microdialysate) of ciprofloxacin (macrodose)
Time frame: Microdialysate sampling (Baseline sampling before study drug administration - sampling over 3 hours - retrodialysis)
In healthy volunteers only for comparison of Cmax of C14 ciprofloxacin and Cmax of ciprofloxacin as macrodose.
Tmax (time of peak concentration in microdialysate) of ciprofloxacin (macrodose)
Time frame: Microdialysate sampling (Baseline sampling before study drug administration - sampling over 3 hours - retrodialysis)
In healthy volunteers only for comparison of Cmax of C14 ciprofloxacin and Cmax of ciprofloxacin as macrodose.
1 secondary outcome
Incidence of Treatment Emergent Adverse Events
Time frame: Screening visit and final examination are performed up to 7 days before/after the actual study day and safety and tolerability assessed.
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 1 Sep 2021.
- Derived from this study: PubMed 34997559Oesterreicher Z, Eberl S, Wulkersdorfer B, Matzneller P, Eder C, van Duijn E, Vaes WHJ, Reiter B, Stimpfl T, Jager W, Nussbaumer-Proell A, Marhofer D, Marhofer P, Langer O, Zeitlinger M. Microdosing as a Potential Tool to Enhance Clinical Development of Novel Antibiotics: A Tissue and Plasma PK Feasibility Study with Ciprofloxacin. Clin Pharmacokinet. 2022 May;61(5):697-707. doi: 10.1007/s40262-021-01091-1. Epub 2022 Jan 7.
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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.
Markus Zeitlinger, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ciprofloxacin and Imipenem in people with Pneumonia, run by Medical University of Vienna at 1 site in Austria.
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 12 inclusion and 12 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 1 Sep 2021. 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 Austria. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Cmax (peak concentration in plasma and epithelial lining fluid) of imipenem and ciprofloxacin (time frame: Plasma over 10 hours and BAL (bronchoalveolar lavage) Sampling at different time points in these 10 hours.). The study lists 9 primary outcomes in all. 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 NCT03177720, 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 1 Sep 2021.