Trial document




drksid header

  DRKS00000098

Trial Description

start of 1:1-Block title

Title

The penetration of moxifloxacin(BAY 12-8039) into the excretory pancreatic secret after intravenous application

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Pancreatic carcinoma, chronic pancreatitis and duodenal disorders can result in a blockage of the digestive tract.
This can allow bacteria to proliferate resulting in infections, particularly after a surgery. Antibiotic administration is a standard treatment, however there is a need to test the efficacy of newly developed antibiotic agents.
Moxifloxacin (tradename Avalox®) is a commonly used antibiotic which has been licensed for use in Germany by the Federal Institute for Drugs and Medical Devices since 1999. So far a registration is still open in Europe for the treatment of abdominal infections. However the efficacy and compatibility of moxifloxacin against abdominal infections has already been demonstrated in clinical trials. These results lead to Moxifloxacin?s registration for the treatment of abdominal infections in the USA by FDA. In the present clinical trial we further analyse the secretion of moxifloxacin into pancreatic juice. In particular both the penetration rate into the pancreatic secretion and the concentration of moxifloxacin in the pancreatic secretion will be measured.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The present clinical trial is a one-armed unicentric prospective non randomized clinical phase 1 study. The major inclusion criterion is a planned elective pancreatic resection or pancreatic jejunostomy for pancreatic carcinoma or chronic pancreatitis. In the course of the surgery a perioperative and continued antibiotic prophylaxis for 7 days is indicated at preexisting cholestasis. Moxifloxacin is an appropriate antibiotic for this indications due to its broad activity and very good human tissue penetration. The rationale for this clinical trial is to demonstrate the efficacy of moxifloxacin for the treatment of acute pancreatitis and necrotic pancreatitis with an underlying infection.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000098
  •   2009/05/08
  •   2009/02/10
  •   yes
  •   Approved
  •   370/08, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2008-005273-35 
  •   UKF001883  (Register Klinischer Studien des Universitätsklinikums Freiburg)
  •   4034668 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   K85 -  Acute pancreatitis
  •   pancreatic necrosis, pre-existent obstructiv cholestasis
  •   C25 -  Malignant neoplasm of pancreas
  •   K86.1 -  Other chronic pancreatitis
  •   C24.0 -  Malignant neoplasm: Extrahepatic bile duct
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   20 patients with pancreatic jejunostomy receive 400mg Moxifloxacin (BAY 12-8039) given either intravenously or orally instead of the antibiotic Ciprofloxacin for 7 days (day 1-7 post surgery) as standard.
    Evaluation of the secretion of moxifloxacin into pancreatic juice and the kinetics of moxifloxacin in the pancreatic juice of patients undergoing elective pancreatic head resection for pancreas carcinoma or chronic pancreatitis. The measuring of moxifloxacin concentrations is to be made by the pancreatic duct catheter.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   I
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Concentration of moxifloxacin in the pancreatic secretion (day1-7 post surgery) and rate of penetration into the pancreatic secretion (concentration in secretion / concentration in tissue)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Occurance of infectious complications
- safety and tolerance of the study medication

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2010/12/03
  •   20
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- patients > 18 years of age with proposed elective pancreatic head resection and pancreatic jejunostomy for pancreas carcinoma, lesion of papilla Vateri or duodenum or chronic pancreatitis
- previous discharge of bile duct by percutaneous PTD or endoscopic discharge because of indolent icterus.
- PPPD or classical 'Kausch-Whipple' surgery
- preoperative PTD or ERCP due to obstructive cholestasis
- preoperative recanalisation of the portal vein or further vena because of chronic pancreatitis
- preoperative application of Somatostatin, Glucagon, Calcitonin, or Aprotinin
- reconstruction of the passage by pancreatic jejunostomy and pancreatic duct catheter
- available informed-consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- preoperative chemoradiotherapy
- preoperative radiotherapy or chemotherapy
- preoperative therapy with corticosteriods up to 1 week before surgery
- surgery in anamnesis within one week before surgery (except laparoscopic staging)
- preoperative liver cirrhosis Child B or C
- impossible operability, intraoperative change of surgical procedure
- extension of surgical intervention to liver resection
- known incompatibility to Fluorochinolons
- ascites and suspicion of spontaneous bacterial peritonitis
- pancreatic, peripancreatic sepsis or intra-abdominal infection because of pancreatitis
- perforated septic ulcer or traumatic (duodenal) perforation in the upper gastro-intestinal system about <24 hours
- traumatic perforation of the small intestine or colon about <12 hours
- transmural intestinal necrosis due to an acute embolic, thrombotic or mechanical occlusion
- infection, which requires a longer anti-infective treatment as the duration of the medication of the study; patients, who are in need of a antibiotic lavage of the abdominal cavity or the surgical wound
- essential 'open abdominal lavage'
- females with genital (gynaecological) infections
- planned relaparotomy
- known hypersensitivity towards the medication of the study
- pregnancy, lactation period or female, whose a pregnancy can?t excluded
- serious, life-threatening diseases at lifespan less than 48 hours respectively. APACHE-Score >25;
- Neutropenia (amount of neutophils <1000 cells / microlitre) because of cancer or chemotherapy
- known immunosuppressive long-term therapy (included systemic long-term treatment with >15 mg Prednisone or a Prednisone equivalent per day);
- HIV-seropositive patients with CD4-cells <200/microlitre or HIV-seropositive patients, who obtain HAART (Please note: a HIV-test is not required for this described study)
- liver cirrhosis in terminal stage (Child-Pugh C) or increase of Transaminases over the 5-fold of the upper standard value
- central or peripheral neuropathy (such as epilepsy or psychosis);
- clinical appreciable bradykardia
- symptomatic cardiac dysrhytmia in anamesis
- known congenital or sporadic QTc-extension or treatment von concomitant medication, which prolong the QTc-intervall (such as Cisaprid, anti-arrhythmics of class IA and III as Amiodaron, Sotalol, Disopyramid, Chinidin and Procainamid);
- disorders of the electrolyte balance, especially untreated hypokalaemia;
- affections of tendons under treatment with Chinolons in anamesis;
- previous participation to this study or treatment with study medication within the last 30 days
- known or assumed bacterial concomitant infection, with requires an additional systemic treatment
- treatment with a systemic (oral or parenteral) antibiotic agent 24 hours before the surgery.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • UNIVERSITAETSKLINIKUM FREIBURG Allgem.- und Viszeralchirurgie
    • Mr.  Prof. Dr. med.  Tobias  Keck 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • UNIVERSITAETSKLINIKUM FREIBURG Allgemeine- und Viszeralchirurgie
    • Mr.  Prof. Dr. med.  Tobias  Keck 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • UNIVERSITAETSKLINIKUM FREIBURG Allgem.- und Viszeralchirurgie
    • Mr.  Prof. Dr. med.  Tobias  Keck 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bayer Vital GmbH
    • Mr.  Dr. med.  Frank M.  Künkele 
    • Gertrud-von-le-Fort-Str. 32c
    • 97074  Würzburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/12/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.