Condition category
Circulatory System
Date applied
08/06/2004
Date assigned
13/07/2004
Last edited
19/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.charite.de/ch/neuro/forschung/teams/experimentell/pantheris.htm

Contact information

Type

Scientific

Primary contact

Dr Guy Arnold

ORCID ID

Contact details

Klinik für Neurologie
Campus Charité Mitte
Charité Universitätsmedizin Berlin
Schumannstr. 20/21
Berlin
10117
Germany
+49 (0)30 450 560 101
guy.arnold@charite.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PANTHERIS

Study hypothesis

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

Ethics approval

Approved by the ethics committee of Charité Hospital on the 23rd September 2002.

Study design

Double blind, randomised and controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Stroke

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

Moxifloxacin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2003

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Immunosupressive therapy
2. Pregnancy
3. Antibacterial therapy within the last 24 hours before inclusion
4. Contraindication for moxifloxacin

Recruitment start date

01/06/2003

Recruitment end date

30/06/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Klinik für Neurologie
Berlin
10117
Germany

Sponsor information

Organisation

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Sponsor details

Klinik für Neurologie
Campus Charité Mitte
Schumannstr. 20/21
Berlin
10117
Germany
+49 (0)30 450 560 020
andreas.meisel@charite.de

Sponsor type

University/education

Website

http://www.charite.de/

Funders

Funder type

University/education

Funder name

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18478129

Publication citations

  1. Results

    Harms H, Prass K, Meisel C, Klehmet J, Rogge W, Drenckhahn C, Göhler J, Bereswill S, Göbel U, Wernecke KD, Wolf T, Arnold G, Halle E, Volk HD, Dirnagl U, Meisel A, Preventive antibacterial therapy in acute ischemic stroke: a randomized controlled trial., PLoS ONE, 2008, 3, 5, e2158, doi: 10.1371/journal.pone.0002158.

Additional files

Editorial Notes