Hand washing study

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2018
INTERVENTION: Healthy volunteers are randomly allocated to one of two groups. Randomisation is computer‐generated and occurs in block sizes of 6. The clinical study team is un‐blinded due to the nature of the intervention however, the study lab team who are processing samples and assessing for nasal colonisation are blinded until the end of the study. Both groups use 70% ethanol solution to decontaminate hands before the transmission attempt. This is sprayed twice on to each of the palmer and dorsal surfaces, approximately 15‐20 cm from the hands (total of 4mls of ethanol solution). Participants are then asked to follow WHO hand rubbing protocol for 30 seconds and allow hands to air dry. Exposure Procedure: using a micropipette a droplet of bacterial broth containing the desired dose of pneumococcus is placed in the anatomical snuff box of one hand and spread around this area using the top of the micropipette. Control group: Participants are then asked to immediately rub the area of hand that the bacterial stock had been exposed around their nasal orifice while sniffing, in an attempt to transmit part of the bacterial stock into both nares. Intervention group: Participants are then asked to wash their hands using antibacterial soap. Hand washing protocol with interventional product: 1. The participant sparingly wets his/her contaminated hands by rapidly passing them under the tap 2. Study personnel dispense one pump of Lifebuoy soap into the palms of the subject’s cupped hands 3. The participant washes/lathers both hands for 10 seconds ± 1 second in a controlled fashion 4. Th participant then rinses his/her hands for 30 seconds ± 1 second under a stream of tap water Following this, particpants are askedto rub the area of hand that the bacterial stock had been exposed around their nasal orifice while sniffing, in an attempt to transmit part of the bacterial stock into both nares. Post exposure‐ The participant is moved into a semi‐recumbent position and remains so for CONDITION: Pneumonia ; Respiratory ; Pneumonia PRIMARY OUTCOME: Detection of the exposed pneumococci is measured using classical culture methods at any time point from nasal wash recovered from participants at days 2, 6/7 and 9/10 after first pneumococcal exposure. 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. Fluent spoken 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 SECONDARY OUTCOME: 1. Occurrence of pneumococcal colonisation determined by the presence of pneumococcus in nasal wash is detected using classical microbiology at each time point post exposure at days 2, 6/7 and 9/10 ; 2. The density of pneumococcal colonisation in nasal wash at each time point following pneumococcal exposure is detected using classical microbiology at days 2, 6/7 and 9/10; 3. The area under the curve of pneumococcal colonisation density following pneumococcal exposure is detected using classical microbiology at days 2, 6/7 and 9/10; 4. The duration of experimental pneumococcal colonisation determined by the last nasal wash following pneumococcal exposure in which pneumococcus is detected using classical microbiology ; 5. The occurrence of pneumococcal colonisation determined by the presence of pneumococcus in nasal wash at any time point post exposure up to and including day 9/10, detected using qPCR; 6. Endpoints 1‐4 detected using qPCR instead of classical microbiology methods
Epistemonikos ID: c63bda6b0a0f4392212e771085d2cfad99536c61
First added on: Aug 24, 2024