Contact information
Type
Scientific
Primary contact
Dr J C van Meurs
ORCID ID
Contact details
Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
+31 (0)10 401 7777
vanMeurs@oogziekenhuis.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OZR-2001-18; NTR189
Study information
Scientific title
Acronym
Study hypothesis
Intravitreal injection of vancomycin 0.2 mg, gentamycin 0.05 mg, and dexamethasone diphosphate 400 mg reduces tissue damage in patients with bacterial endophthalmitis.
Ethics approval
Received from the local medical ethics committee
Study design
Randomised, double-blind, placebo controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Post-operative bacterial endophthalmitis
Intervention
Intravitreal injection of vancomycin 0.2 mg, gentamycin 0.05 mg, and dexamethasone diphosphate 400 mg or placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
Vancomycin, gentamycin, dexamethasone diphosphate
Primary outcome measures
Vision (ETDRS) after 3, 6 and 12 months, panbacterial polymerase chain reaction (PCR).
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/01/2003
Overall trial end date
01/01/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Post-cataract bacterial endophthalmitis
2. Strong, and increasing, irritation of anterior chamber and/or vitreous during post-operative 8 weeks interval
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
150
Participant exclusion criteria
Antibiotics treatment
Recruitment start date
01/01/2003
Recruitment end date
01/01/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Oogziekenhuis Rotterdam
Rotterdam
3011 BH
Netherlands
Sponsor information
Organisation
Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (The Netherlands)
Sponsor details
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
+31 (0)10 401 77 77
info@oogziekenhuis.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Foundation of Scientific Research at the Eye Hospital (Stichting Wetenschappelijk Onderzoek het Oogziekenhuis) (The Netherlands)
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