MAPS-2: Metoclopramide and SOD mouth paste to prevent pneumonia vs 1
Research type
Research Study
Full title
The Metoclopramoide and selective oral decontamination for Avoiding Pneumonia after Stroke (MAPS-2) Trial: a 2x2 double-blind, randomized controlled trial of metoclopramide and selective oral decontamination for the prevention of pneumonia in patients with dysphagia after an acute stroke.
IRAS ID
207212
Contact name
Christine Roffe
Contact email
Sponsor organisation
University Hospital of North Midlands NHS Trust
Eudract number
2016-003406-14
ISRCTN Number
ISRCTN14124645
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
Pneumonia is a common complication of stroke and associated with a doubling of mortality, longer length of hospital stay, and an increase in long-term disability. It is distressing to patients and affects their ability to recover. Stroke-associated pneumonia is most likely to occur in patients who have problems swallowing and is due to aspiration of contaminated saliva and vomited or regurgitated stomach contents. Mild swallowing problems can be managed by modification of diet, whereas patients with severe swallowing problems often require feeding tubes to maintain nutrition. Stroke patients who are fed via tubes are at particularly high risk of pneumonia.
The MAPS-2 study will test two ways of preventing pneumonia in these patients. The first is reducing gastric reflux by prophylactic use of an antiemetic (metoclopramide) and the second is reducing risks of oral bacteria causing infection by decontamination of the oral mucosa with an antimicrobial mouth paste.
Both metoclopramide and selective oral decontamination are supported by evidence from one small study each. While promising, it cannot be excluded that the reduction of pneumonia was due to chance. MAPS-2 tests each of the two interventions in randomised controlled trial over 1100 stroke patients in 50 hospitals in the UK. Patients will be given metoclopramide or matching placebo (dummy drug) and an antimicrobial mouth paste (containing two antibiotics and one antifungal agent) or placebo paste for up to 21 days or until their swallow improves. The study will provide reliable evidence to show whether metoclopramide, selective oral decontamination, or both, prevent pneumonia. Each of these treatments can potentially reduce mortality after stroke, and MAPS-2 will provide the data show whether this is the case.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
17/NW/0058
Date of REC Opinion
4 Apr 2017
REC opinion
Further Information Favourable Opinion