Preventive antibacterial short-term therapy in patients with acute ischemic infarction in the territory of the middle cerebral artery (MCA)

ISRCTN	ISRCTN74386719
DOI	https://doi.org/10.1186/ISRCTN74386719
Secondary identifying numbers	N/A

Submission date: 08/06/2004
Registration date: 13/07/2004
Last edited: 19/05/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Guy Arnold
Scientific

Klinik für Neurologie
Campus Charité Mitte
Charité Universitätsmedizin Berlin
Schumannstr. 20/21
Berlin
10117
Germany

Phone	+49 (0)30 450 560 101
Email	guy.arnold@charite.de

Study information

Study design	Double blind, randomised and controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Scientific title
Study acronym	PANTHERIS
Study objectives	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(s)	Approved by the ethics committee of Charité Hospital on the 23rd September 2002.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Moxifloxacin
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/06/2003
Completion date	30/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	80
Key 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
Key exclusion criteria	1. Immunosupressive therapy 2. Pregnancy 3. Antibacterial therapy within the last 24 hours before inclusion 4. Contraindication for moxifloxacin
Date of first enrolment	01/06/2003
Date of final enrolment	30/06/2008

Locations

Countries of recruitment

Germany

Study participating centre

Klinik für Neurologie

Berlin
10117
Germany

Sponsor information

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

Klinik für Neurologie
Campus Charité Mitte
Schumannstr. 20/21
Berlin
10117
Germany

Phone	+49 (0)30 450 560 020
Email	andreas.meisel@charite.de
Website	http://www.charite.de/
"ROR"	https://ror.org/001w7jn25

Funders

Funder type

University/education

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	14/05/2008		Yes	No