Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT00447304
Eligibility Criteria:
Inclusion Criteria:
* Patients of age \> 18 years
* Patients with acute cholecystitis based on three of the following signs
* abdominal pain in the upper right quadrant
* Murphy's sign
* leucocytosis \> 10 /ml
* rectal temperature \> 38 °C or \< 36.5 °C plus
* cholecystolithiasis (stones / sludge) or sonographic signs of cholecystitis (thickening and triple layer formation of the gall bladder wall)
* Immediate antibiotic therapy (400 mg Moxifloxacin i.v. once a day)
* Laparoscopic cholecystectomy possible within 24 hours after presentation of the patient
* Informed consent
Exclusion Criteria:
* ASA IV and V (table 2)
* Septic shock
* Perforation or abscess of the gall bladder
* Impossibility of laparoscopic surgery (further surgery, surgeon, …)
* Additional need of antibiotics due to secondary disease
* Known intolerability of Moxifloxacin
* Known or possible pregnancy, breast feeding
* Life-threatening diseases (life-expectancy \< 48 hours)
* End-stage liver disease (Child-Pugh C)
* Psychiatric or severe neurologic disease
* Relevant bradycardia or other symptomatic arrhythmias
* Significant cardiac disease
* Known long QT-disorders
* Electrolyte disorders, especially hypocalcemia
* Known intolerability of chinolones
* Earlier participation in this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00447304
Study Brief:
Protocol Section:
NCT00447304