Table 2 Protocol revision chronology
Date | Protocol version and amendments |
|---|---|
5 May 2010 | Original protocol |
15 August 2010 | Protocol version 1.1. Amendments: exclusion criterion ‘death seems imminent’ added; compulsory urine analysis and culture on admission omitted. |
9 December 2010 | Protocol version 1.2. Amendments: new study centres with new estimations of included patients were added; paragraph 6.6 ‘drug-accountability’: badge number of the administered ceftriaxone will be noted by the nurse administrating the medication into the ‘drug accountability form’ according to GCP-guidelines for pharmacies; paragraph 7.2 ‘randomisation, blinding and treatment allocation’: randomisation will not be stratified according to stroke type, solely by study centre and stroke severity; assessment of blinded outcome is specified as performed by a person not involved in the trial team; performance of interim analyses is specified as performed by an independent statistician not involved in the trial team; paragraph 8.2 ‘adverse and serious adverse events’: for each participating centre, a flowchart of serious adverse event/suspected unexpected serious adverse reactions (SAE/SUSAR) reporting will be provided in the local Investigator File; paragraph 8.5 ‘data monitoring’: reference to the monitoring plan is added. |
10 January 2014 | Protocol version 1.3. Amendment: change in primary analysis of primary outcome from dichotomised analysis to ordinal regression analysis according to the proportional odds model. |
Total course of study | Participating centres were added (all participating centres are shown in Table 3). |