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ISRCTN
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ISRCTN74386719
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ClinicalTrials.gov identifier
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Public title
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Preventive antibacterial short-term therapy in patients with acute ischemic infarction in the territory of the middle cerebral artery (MCA)
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Scientific title
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Acronym
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PANTHERIS
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Serial number at source
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N/A
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Study hypothesis
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Strokes are frequently accompanied by severe bacterial infections (21 - 65% among unselected patients), 10 - 22% of which were pneumonias. Complicating infections constitute a leading cause of stroke mortality. We have been able to demonstrate in an animal model that a profound stroke related immunodepression contributes to the rise of complicating infections, and that these infections can effectively be avoided by preventive antibacterial therapy (PAT) with Moxifloxacin. Importantly, in this stroke model PAT not only prevents infections, it also improves survival and outcome, significantly.
The following primary hypothesis shall be tested:
1. PAT with Moxifloxacin reduces the incidence of complicating infections after (primary aim)
Secondary aims:
2. PAT also reduces the infarct volume and improves the neurological outcome
3. Stroke causes a immunodepression, which is mediated by the sympathetic nerve system
4. PAT does not lead to a development of resistency among facultatively pathogenous bacteriae
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Ethics approval
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Approved by the ethics committee of Charité Hospital on the 23rd September 2002.
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Study design
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Double blind, randomised and controlled study
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Stroke
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Participants - inclusion criteria
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The double blind, randomised and controlled study will be carried out on two groups of about 40 patients each. Since patients with large infarctions in the territory of the middle cerebral artery and a subsequent severe neurological deficit (National Institutes of Health-Stroke-Scale [NIHSS] greater than 11) have the highest risk of pneumonia, we include only this subpopulation of stroke patients in our study.
Inclusion criteria:
1. Severe ischemic strokes in MCA territory (area greater than 50% in cerebral computed tomography [CCT], NIHSS greater than 11)
2. Within 36 hours after stroke onset
3. Older than 18 years
4. No infection
5. No intracerebral bleeding
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Participants - exclusion criteria
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1. Immunosupressive therapy
2. Pregnancy
3. Antibacterial therapy within the last 24 hours before inclusion
4. Contraindication for moxifloxacin
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Anticipated start date
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01/06/2003
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Anticipated end date
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30/06/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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80
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Interventions
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Patients of group A are being treated according to the current standards of therapy. With respect to antibiotics, they are fully and effectively treated as soon as an antibiotic medication is indicated i.e. as soon as an infection is diagnosed. For reasons of the double blind study design, during the first five days after stroke, these patients receive a placebo (Riboflavin) instead of a preventive antibacterial medication.
Patients of group B are being treated according to the new regimen under investigation with a preventive antibacterial medication (Moxifloxacin 400 mg intravenous [iv]) for five days. Patients with outbreak of an intercurrent infection, were treated according to standardised protocol (SOP). The study medication will be continued.
This design enables us to work with a placebo control and yet have all patients with infections properly treated according to the current medical standards. Thus, the use of a placebo control in this study does not imply that some patients receive an ineffective medication for a diagnosed condition. It means that the new therapeutic regimen of preventive treatment is being tested against the current standard of post hoc treatment.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
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Trial website
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http://www.charite.de/ch/neuro/forschung/teams/experimentell/pantheris.htm
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18478129
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Contact name
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Dr
Guy
Arnold
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Address
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Klinik für Neurologie
Campus Charité Mitte
Charité Universitätsmedizin Berlin
Schumannstr. 20/21
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City/town
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Berlin
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Zip/Postcode
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10117
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Country
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Germany
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Tel
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+49 (0)30 450 560 101
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Fax
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+49 (0)30 450 560 932
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Email
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guy.arnold@charite.de
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Sponsor
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Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
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Address
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Klinik für Neurologie
Campus Charité Mitte
Schumannstr. 20/21
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City/town
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Berlin
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Zip/Postcode
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10117
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Country
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Germany
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Tel
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+49 (0)30 450 560 020
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Fax
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+49 (0)30 450 560 915
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Email
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andreas.meisel@charite.de
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Sponsor website:
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http://www.charite.de/
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Date applied
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08/06/2004
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Last edited
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19/05/2008
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Date ISRCTN assigned
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13/07/2004
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