Doppelblinde, randomisierte, prospektive multizentrische klinische Studie zur Definition der optimalen antibiotischen Therapiedauer bei Patienten mit unkomplizierter akuter Cholangitis: Moxifloxacin oral vs. Placebo oral nach Entfieberung zur Fortführung der initial intravenösen Therapie mit Moxifloxacin. Duration of Moxifloxacin therapy for acute cholangitis – a randomized, placebo-controlled, multicenter study. The MONA LISA study. - The Mona Lisa Study

• Register: EUCTR
• Last refreshed on: 7 August 2012
• Main ID: EUCTR2005-004851-37-DE
• Date of registration: 10/12/2007
• Prospective Registration: Yes
• Primary sponsor: Freistaat Bayern, vertreten durch die Universität Regensburg, Klinikum
• Public title: Doppelblinde, randomisierte, prospektive multizentrische klinische Studie zur Definition der optimalen antibiotischen Therapiedauer bei Patienten mit unkomplizierter akuter Cholangitis: Moxifloxacin oral vs. Placebo oral nach Entfieberung zur Fortführung der initial intravenösen Therapie mit Moxifloxacin. Duration of Moxifloxacin therapy for acute cholangitis – a randomized, placebo-controlled, multicenter study. The MONA LISA study. - The Mona Lisa Study
• Scientific title: Doppelblinde, randomisierte, prospektive multizentrische klinische Studie zur Definition der optimalen antibiotischen Therapiedauer bei Patienten mit unkomplizierter akuter Cholangitis: Moxifloxacin oral vs. Placebo oral nach Entfieberung zur Fortführung der initial intravenösen Therapie mit Moxifloxacin. Duration of Moxifloxacin therapy for acute cholangitis – a randomized, placebo-controlled, multicenter study. The MONA LISA study. - The Mona Lisa Study
• Date of first enrolment: 28/12/2007
• Target sample size: 264
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004851-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Acute uncomplicated cholangitis
MedDRA version: 9.1 Level: LLT Classification code 10008605 Term: Cholangitis acute

Intervention(s)

Trade Name: Avalox
Product Name: Avalox 400mg / 250ml Infusionslösung
Product Code: BAY 12-8039
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: MOXIFLOXACIN
CAS Number: 151096092
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-

Trade Name: Avalox
Product Name: Avalox 400 mg Filmtabletten
Product Code: BAY 12-8039
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MOXIFLOXACIN HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: Evaluation of the neccessary duration of antibiotic therapy for patients with acute uncomplicated cholangitis.

Secondary Objective: 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.

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.

Secondary ID(s)

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