E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute uncomplicated cholangitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008605 |
E.1.2 | Term | Cholangitis acute |
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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 |
Evaluation of the neccessary duration of antibiotic therapy for patients with acute uncomplicated cholangitis. |
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E.2.2 | Secondary objectives of the trial |
To compare the length oth the actual hospital stay among patients receiving a short or a long course of antibiotic therapy.
To compare the mortality, the rate of complications and the rate of relapses among patients receiving a short or a long course of antibiotic therapy.
To compare the rate of isolated fluoroquinolone resistant bacteria among patients receiving a short or a long course of antibiotic therapy.
To dertermine the clinical course ot patients during the non-randomized i.v. treatment with moxifloxacin.
To meassure the biliary concentration of moxifloxacin in specimens obtained during ERCP.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- adult age (≥ 18 years)
- acute uncomplicated cholangitis, defined as follows (all 3 criteria must be met): 1. aute febrile disease: (temperatur ≥ 38.0°C at least once in the 24 Stunden prior or after the time point of hospital admission, duration of febrile disease not longer than 7days) 2. Cholestasis documented by at least one imaging technique (sonographie / CT / ERCP / MRCP; maximal diameter of the common bile duct>7 mm, >10 mm for patients with prior cholecystectomy) 3. Obstruction of the common bile duct provenly or probably caused by biliary concrement(s) in the middle or distal third of the common bile duct.
- Written informed consent.
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E.4 | Principal exclusion criteria |
- Cholangitis, not caused by biliary concrements
- Manifested Pankreatitis (not assymptomatic elevation of serum lipase)
- Severe sepsis (defined as sepsis with greater or equal of one organfailure or necessary intensive care greater than 24 hours)
- Intervention ot the biliary tract (ERCP / PTCD / Operation) in the 14 days prior to hospital admission
- Oral antibiotic treatment longer than 48 hours prior to hospital admission
- Antibiotic therapy with any other antibiotic than moxifloxacin for longer than 24 hours after hospital admission
- Pregnancy, breast-feeding mothers, or women for whom a pregnancy can´t be rouled out
- Known intolerance, allergy or contraindication(s) for moxifloxacin or other fluoroquinolones
- Advanced liver cirrhosis (Child-Pugh stage C)
- Chronic liver diseases with elevation of transaminases above 5-time the upper limit of normal
- Terminal renal failure neccessitating dialysis
- Life exspectancy below 3 month
- Severe immunosuppression (≥ 20mg prednisolon per day, or any other medical immunosuppression, patients with known HIV–infection, patients with prior transplantations (BMT or solid organ)
- Chemotherapy for a malignant disease in the 14 day prior or during the study period
- Known epilepsy
- Clinical relevant bradykardia (HR continiously < 40/min)
- Symptomatic arrhythmias in the medical history (not atrial fibrilation)
- Clinical relevant heart insufficiency (leftventricular EF<30%)
- Known concgenital or sporadic QTc-Prolongation or concommittant use of medication that prolongs the QTc-interval (e.g. cisapride, antiarrhythmic drugs of the class IA and III like amiodarone, sotalol, disopyramid, chinidine and procainamide)
- Disturbancies of serum electrolytes, especially untreated hypokalemia
- Tendon-related problems that occured during prior treatment with a fluoroquinolone
- Known or suspected additional bacterial infection neccessitating additional systemic antibiotic therapy
- Prior participation in this study or participation in any therapeutic study in the 30 days prior to the hospital admission or during the study period |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary enpoint of the trial is the combined rate of relapses, complications and death in the 28 days following the initial hospital admission.
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
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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An interim analysis will be performed after the end of the 28-day-long study period of the 100th patient enroled in the trial. In the case of a significant differance in the primary endpoint of the trial, the trail will be closed at this point. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |