ose and throat study

Not Applicable

Completed

• Conditions: Specialty: Ear, nose and throat, Primary sub-specialty: Ear, nose and throat; UKCRC code/ Disease: Inflammatory and Immune System/ Certain disorders involving the immune mechanism; Ear, Nose and Throat; Ear, nose and throat

• Registration Number: ISRCTN85509051
• Lead Sponsor: iverpool School of Tropical Medicine

Brief Summary

2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31361601/ (added 05/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-11
• Study Completion: 2018-09-02
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Phase 1:
1. Have capacity to give informed consent
2. Aged 18-50 years (ages chosen to minimise discrepancy in the immune response and to minimise the risk of pneumococcal disease)
3. Speak fluent English (to ensure a comprehensive understanding of the research project and their proposed involvement, in order to minimise any communication issues to maximize participant safety)

Phase 2:
1. Have capacity to give informed consent
2. Aged 18-50 years (ages chosen to minimise discrepancy in the immune response and to minimise the risk of pneumococcal disease)
3. Speak fluent English (to ensure a comprehensive understanding of the research project and their proposed involvement, in order to minimise any communication issues to maximize participant safety)
4. Consented for elective nasal septum and or turbinate surgery

Exclusion Criteria

Stage One-Optimization group
1. Chronic rhinosinusitis (CRS) with or without nasal polypoidal disease
2. Use of oral of nasal steroid spray up to the day of surgery
3. Currently involved in another study unless observational or in follow-up phase (non-interventional)

Stage Two
Group One
1. Currently involved in another study unless observational or in follow-up phase (non-interventional)
2. Close contact with at risk individuals (children under 5 years, immunosuppressed adults, elderly, chronic ill health) – to minimise risk of pneumococcal transmission
3. Current regular smoker (smokes daily) or previous regular smoker that has stopped smoking less than 12 months ago (< 10 years).
4. Asthma or respiratory disease – to minimise risk of pneumococcal disease
5. Current acute or chronic rhinosinusitis with or without nasal polypoidal disease
6. Pregnant - to minimise the risk of pneumococcal disease
7. Allergic to penicillin or amoxicillin
8. Allergic to local anaesthetic
9. On medication that may affect the immune system in any way e.g. steroids
10. Been involved in a clinical trial involving EHPC over the last 3 years
11. Current acute severe febrile illness
12. Taking long term antibiotics
13. On oral anti-platelets or warfarin therapy

Group Two
1. Currently involved in another study unless observational or in follow-up phase (non-interventional)
2. Close contact with at risk individuals (children under 5 years, immunosuppressed adults, elderly, chronic ill health) – to minimise risk of pneumococcal transmission
3. Current regular smoker (smokes daily) or previous regular smoker that has stopped smoking less than 12 months ago (< 10 years).
4. Asthma or respiratory disease – to minimise risk of pneumococcal disease
5. Current acute or chronic rhinosinusitis with or without nasal polypoidal disease
6. Pregnant - to minimise the risk of pneumococcal disease
7. Allergic to penicillin or amoxicillin
8. On medication that may affect the immune system in any way e.g. steroids,
9. Been involved in a clinical trial involving EHPC over the last 3 years
10. Current acute severe febrile illness
11. Taking long term antibiotics
12. Previous tonsillectomy

*Participants that have been started on nasal steroid spray to relive the nasal blockage symptoms will be advised to stop **Participants in Group 2 on oral anti-platelets therapy of warfarin are advised to stop the medication up to seven days prior to their elective nasal surgery and additional nasal and tonsillar biopsy to minimise the risk of bleeding as per the pre-operative assessment clinic advise.

Study & Design

• Study Type: Interventional
• Study Design: Not specified