MAPS‐2.

Study name	The Metoclopramide and selective oral decontamination for Avoiding Pneumonia after Stroke trial (MAPS‐2)
Methods	2×2 factorial double‐blinded RCT
Participants	1160 participants Inclusion criteria: adults with clinical diagnosis of acute stroke; within 9 hours of stroke onset; moderate‐to‐severe neurological impairment with NIHSS score ≥ 10; unable to take a normal oral diet of fluids Exclusion criteria: evidence of vomiting since stroke onset; pre‐existing swallowing problem; known oesophageal pathology that might interfere with placement of an NGT, probable or definite pneumonia, contraindications to metoclopramide, epilepsy, gastrointestinal obstruction, perforation, or haemorrhage, gastrointestinal surgery within the last week, Parkinson's disease, treatment with levodopa or dopaminergic agonists, phaeochromocytoma or neuroleptic malignant syndrome or tardive dyskinesia or methaemoglobinaemia or NADH cytochrome; people with severe liver disease or kidney disease; known allergy to colistin; pregnant or breastfeeding; other comorbid conditions with a life expectancy < 3 months at the discretion of the clinical treating team; inability to gain consent from the patient or a legal representative or refusal of consent Recruited from 50 UK emergency department and acute stroke wards
Interventions	Metoclopramide and selective oral decontamination paste Metoclopramide and placebo selective oral decontamination paste Placebo metoclopramide and selective oral decontamination paste Placebo metoclopramide and placebo selective oral decontamination paste Participants will receive metoclopramide or placebo for 21 days or until the NGT is removed, and selective oral decontamination paste for 21 days or until the NGT is removed
Outcomes	Primary outcomes: mortality rates up to the end of study Secondary outcomes: pneumonia within 14 days; number of days of antibiotic treatment for pneumonia within the first 30 days; neurological recovery measured using the NIHSS at 30 days; disability measured using the modified Rankin Scale at 90 days; quality of life measured using the EuroQol Five Dimensions questionnaire at 90 days Data collection: daily clinical logs (14 days). Follow‐up at 30 days (or day of discharge if sooner) and follow‐up at 90 days for secondary outcomes
Starting date	1 December 2017; anticipated completion September 2019
Contact information	Professor Christine Roffe, Institute for Applied Clinical Sciences (IACS) Keele University Guy Hilton Research Centre, Thornburrow Drive, Hartshill, Stoke‐on‐Trent, ST4 7QB, UK
Notes	ISRCTN14124645

cRCT: cluster randomised controlled trial; ED: emergency department; NADH: nicotinamide adenine dinucleotide; NGT: nasogastric tube; NIHSS: National Institutes of Health Stroke Scale; RCT: randomised controlled trial.