E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients, who are treated with Moxifloxacin due to clinical indication of respiratory infection or soft tissue infection |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Microbiological Phenomena [G06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary aim of the study is to compare maximum serum levels of moxifloxacin reached by intravenous application versus enteral application. |
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E.2.2 | Secondary objectives of the trial |
to compare the area under the concentration curve received by intravenous application versus enteral application. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-age of at least 18 years - normal gastrointestinal motility (i.e. reflux via gastric tube < 300 ml/d, no vomiting, defecation within the first three days after ICU admission) -treatment of a respiratory tract or soft tissue infection with Moxifloxacin; -sequential application planned, i.e. switch from intravenous to enteral application after four days -written informed consent of the patient or her/his legal representative
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E.4 | Principal exclusion criteria |
- pregnancy or breast feeding - age above 75 years -compromised liver function, i.e. serum levels of bilirubine higher than the twofold of the upper standard value or alanin-aminotransferase or aspartat-aminotransferase higher than the threefold of the upper standard value or liver cirrhosis
-compromised renal function, i.e. creatinin-clearance < 30 ml/min. -oral co-medication with mineralic antacids, sucralfate,magnesium, iron additives, calcium or vitamins -postpyloric enteral nutrition -known intestinal disease, e.g. Crohn´s disease -symptoms of irregular intestinal motility,i.e.: diarrhea (defecation more than 3x a day) reflux of enteral secretions > 300 ml/die via the gastric tube or vomiting -participation in another clinical study
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study is the comparison of the maximum serum levels of moxifloxacin after intravenous versus enteral application of 400 mg of moxifloxacin in the steady state level. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary endpoint of the study is evaluated with the last blood sample on day 8 after inclusion (24 hours after the last oral intake of Moxifloxacin). After completion of the pharmakokinetic examination patients are monitored regarding any adverse event during their whole intensive care sta |
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E.5.2 | Secondary end point(s) |
area under the concentration curve of moxifloxacin serum levels after intravenous versus enteral application of 400 mg moxifloxacin |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The evaluation can be done when the last of blood samples is taken; for practical reasons the blood samples will be processed, frozen and then be analyzed in batches of samples taken from 3 or 4 patients. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The study is finished when the last patient, who has been investigated leaves the intensive care unit. When the last blood sample of a patient is taken, this patient will be monitored for any adverse event during the complete intensive care stay. After transfer or discharge the further treatment is done by the physicians of the normal ward or the practioneers. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |