Condition category
Infections and Infestations
Date applied
14/03/2018
Date assigned
25/04/2018
Last edited
16/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background:
Streptococcus pneumoniae is a leading cause of morbidity and mortality worldwide, causing community acquired pneumonia (CAP), bacterial meningitis and bacteraemia. There is evidence to suggest that exposure of the hands to bacteria can lead to respiratory illnesses and therefore interventions such as handwashing is of significant global health importance. Our pilot study revealed that hand to nose transmission of S.pneumoniae is an important method of bacterial transmission. We now plan to test potential interventions to reduce hand to nose transmission in this randomised control trial design using a hand washing intervention with the antibacterial soap Lifebuoy. The study aims to assess the effect of hand washing with antibacterial soap on the rates of transmission of bacteria from the hand to nose. 10% of the population carry the bacteria in their noses. We know that bacteria can be moved from the hand to the nose causing the spread of disease. We aim to demonstrate if a certain antibacterial soap can stop the bacteria passing from the hand to the nose.

Who can participate?
Healthy volunteers, male and female, age range 18-50

What does the study involve?
Healthy volunteers are randomly allocated to one of two groups; to immediately attempt transmission of the bacteria into their noses post exposure or hand washing with antibacterial soap prior to attempted transmission of the bacteria. All volunteers are exposed to the live bacteria on the back of their hands. Participants are asked to transmit the bacteria by rubbing their noses whilst sniffing. Volunteers are followed up for 2 weeks at clinic appointments where nasal wash samples are taken to see if the bacteria is present in their nose. At the end of the study, volunteers that still have the bacteria present in their nose will be given antibiotics to clear the bacteria.

Risks and Benefits:
The pneumococcal bacteria are live and therefore can pose the risk of pneumococcal related infection. We have inoculated over 1000 healthy volunteers and patients combined without any serious adverse event related to the pneumococcal bacteria. There are no direct benefits to the participants. They will be compensated for their time and inconvenience.

Where is the study run from?
Liverpool School of Tropical Medicine: Accelerator Research Clinic (UK)

How long is the trial expected to run for?
October 2017-July 2019

Who is the main contact?
Angela-Hyder Wright
angela.hyder-wright@lstmed.ac.uk

Trial website

www.lstmed.ac.uk/pneumoniavaccine

Contact information

Type

Public

Primary contact

Mrs Angela Hyder-Wright

ORCID ID

Contact details

Accelerator Research Clinic
3rd Floor Accelerator Building
Liverpool School of Tropical Medicine
1 Daulby Street
Liverpool
L7 8XZ
Liverpool
L7 8XZ
United Kingdom
07595463833
angela.hyder-wright@lstmed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17/NW/0658

Study information

Scientific title

Hand to nose transmission of Streptococcus pneumoniae in healthy participants: randomised control trial assessing the effect of hand washing on transmission

Acronym

Study hypothesis

To evaluate if hand washing with antimicrobial soap affects hand to nose transmission of Streptococcus pneumoniae leading to nasal colonisation.

Ethics approval

NRES Committee North West Liverpool East, 21/12/2018, ref: 17/NW/0658

Study design

Randomised control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Healthy volunteers. Prevention of respiratory infection.

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.


Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

27/10/2017

Overall trial end date

01/07/2019

Reason abandoned

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

170 to allow 136 to complete the study

Participant exclusion criteria

1.Previous pneumococcal vaccination
2.History of major pneumococcal illness
3.Close physical contact with at risk individuals (children under 5 years of age, immunosuppressed adults, elderly, chronic ill health) at discretion of the study doctors and/or PI- minimise risk of pneumococcal transmission
4.Allergy to penicillin/amoxicillin and clarithromycin (or other macrolides)
5.Asthma (on regular medications) or chronic respiratory disease – confounding effect of medications such as corticosteroids, and propensity to infection
6.Any acute dermatological illness or skin injury affecting the hands or face at the discretion of the study doctors and/or PI- confounding effects of topical medications and propensity to infection
7.Taking daily medications that may affect the immune system e.g. steroids, steroid nasal spray, antibiotics and roacutanne decision at the discretion of study doctors and PI
8.Current illness, acute illness within 3 days prior to exposure or antibiotic treatment within 2 weeks of exposure
9.Pregnancy - minimise risk of pneumococcal disease
10.Diagnosed as diabetic or any other illness that can affect patients’ immune system- at the discretion of the study doctors and/or PI
11.Involved in another clinical trial unless observational or in follow-up (non-interventional) phase.
12.Have been involved in an EHPC clinical trial involving pneumococcal inoculation/exposure- at the discretion of study team depending on multiple factors attaining to previous study including previous pneumococcal vaccination, time since participation in the study and colonisation status in that study.
13.History of drug or alcohol abuse
14.History of Smoking
15.Current regular smoker (smokes daily/ smokes > 5 cigarettes per week) - minimise risk of pneumococcal disease
16.Recent smoker i.e. within the last 6 months - minimise risk of pneumococcal disease
17.Ex-smoker with a significant smoking history (>10 pack years) – minimise risk of pneumococcal disease
18.Unable to give fully informed consent

Recruitment start date

30/01/2018

Recruitment end date

01/12/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Liverpool School of Tropical Medicine: Accelerator Research Clinic
1 Daulby Street
Liverpool
L7 8XZ
United Kingdom

Sponsor information

Organisation

Liverpool School of Tropical Medicine

Sponsor details

Carl Henry
Research Governance
1st Floor Wolfson Building
Pembroke Place
Liverpool
L3 5QA
Liverpool
L3 5QA
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

Unilever

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

Intention to publish date

01/08/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes