Evaluation of Innovative Tools in Development of Antibiotics

• Register: ClinicalTrials.gov
• Last refreshed on: 13 September 2021
• Main ID: NCT03177720
• Date of registration: 30/05/2017
• Prospective Registration: No
• Primary sponsor: Medical University of Vienna
• Public title: Evaluation of Innovative Tools in Development of Antibiotics
• Scientific title: Determination of Single-dose Intrapulmonary Pharmacokinetics of Ciprofloxacin and Imipenem in Healthy Subjects and Intubated Patients Suffering From Pneumonia Using Bronchoalveolar Lavage
• Date of first enrolment: May 29, 2016
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03177720
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Austria

Contacts

• Name: Markus Zeitlinger, MD
• Affiliation: Medical University of Vienna

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

- 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.

Exclusion Criteria:

- 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.

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pneumonia

Intervention(s)

Drug: Imipenem

Drug: Ciprofloxacin

Primary Outcome(s)

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.]

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.]

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)]

Cmax (peak concentration in microdialysate) of ciprofloxacin (macrodose) [Time Frame: Microdialysate sampling (Baseline sampling before study drug administration - sampling over 3 hours - retrodialysis)]

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.]

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.]

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.]

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)]

Cmax (peak concentration in plasma, epithelial lining fluid and microdialysate) of C14 ciprofloxacin (microdose) [Time Frame: Plasma sampling over 10 hours and microdialysate sampling.]

Secondary Outcome(s)

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.]

Secondary ID(s)

ELF Cipro

Source(s) of Monetary Support

Please refer to primary and secondary sponsors