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Table 2 Protocol revision chronology

From: Update on the Preventive Antibiotics in Stroke Study (PASS): a randomised controlled phase 3 clinical trial

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).