Hand wash study

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2018
INTERVENTION: Healthy volunteers are randomised to wash their hands or not wash their hands after pneumococcal bacteria is placed on their hands. They are all then asked to transmit the bacteria by wiping their noses whilst sniffing up using the hand that has been exposed to the bacteria.The intervention appointment lasts for up to 1.5 hours. The volunteer is then followed up at day 2, 6/7 and 9/10 for a 15 minute appointment. Following day 9/10, volunteers are contacted if they need to take antibiotics. The method of randomisation is sealed envelopes. The randomisation schedule has been produced by the statistician from the Tropical Clinical Trials Unit (tCTU). The envelopes were then made by 2 members of staff that are not involved in the clinical/ laboratory running of the study. The randomisation is 1:1 and occurs in blocks of 6. The envelope is opened on the day of exposure when the volunteer arrives and has passed all screening processes. CONDITION: Healthy volunteers. Prevention of respiratory infection. ; Infections and Infestations PRIMARY OUTCOME: 1. The presence of pneumococcal bacteria in the nose following exposure using classical microbiological methods. Nasal wash samples are taken pre‐exposure, day 2, day 6/7 and day 9/10. Pneumococcal bacteria serotype is confirmed by a commercially available latex agglutination kit. SECONDARY OUTCOME: 1.The presence of pneumococcal bacteria in the nose following exposure using molecular methods (LytA PCR). Nasal wash samples are taken pre‐exposure, day 2, day 6/7 and day 9/10.; 2.The density of the bacteria in the nose following exposure.Density of bacteria is confirmed by counting the 6B pneumococcal colonies present in the nasal wash samples at day 2, 6/7 and 9/10.; ; INCLUSION CRITERIA: 1.Adults aged 18‐50 years ‐ ages chosen to minimise the risk of pneumococcal infection, and to allow comparison with previously published experimental work done by our group 2. Speak fluent English ‐ to ensure a comprehensive understanding of the research project and their proposed involvement 3.Access to mobile telephone – to ensure safety and timely communication 4.Capacity to give informed consent
Epistemonikos ID: a0dc59fbe582ba360297b4b68e279415f36572d8
First added on: Aug 24, 2024