Medical condition: Non-complicated lower respiratory tract infection Medical condition in lay language: non-complicated chest infection Therapeutic areas: Diseases [C] - Respiratory Tract Diseases [C08] Respiratory
Conditions
Interventions
Doxycycline 100mg orally for five days. Two tablets on day 1 and one tablet on days 2-5, OR matched placebo. Participants will be randomised using the ALEA Clinical randomisation tool on a 1:1 ratio.
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 65 years and over 2. Presenting in primary care with signs and symptoms suggestive of an uncomplicated LRTI, defined as acute cough (rated moderately severe or worse and lasting for 14 days or less), and at least one of the following signs or symptoms: productive cough, rhonchi on auscultation, temperature =38oC, dyspnoea 3. One or more of the following risk factors for complicated illness: 3.1. Age 80 or over 3.2. >=1 unplanned hospital admissions in the previous year 3.3. Type 1 or 2 diabetes, chronic cardiovascular disease, chronic lung disease, chronic kidney disease, chronic liver disease, chronic neuromuscular disease 3.4. Clinical frailty score >=4
Exclusion criteria
Exclusion criteria: 1. Clinical diagnosis of pneumonia 2. A known positive test for a viral respiratory pathogen (e.g. COVID-19 or influenza) during current illness (testing will only occur if part of routine practice) 3. Cough thought to most likely have a non-infective origin (e.g. PE, LVF) 4. Patient needs same-day secondary care assessment or hospital admission 5. Significant impaired immunity, e.g. hematologic malignancy, chronic use of oral steroids (=5mg prednisolone (or equivalent) per day for 7 days or more), known immunodeficiencies 6. Moderate to severe COPD 7. Hospitalisation in the month before index consultation 8. Antibiotic use for respiratory tract infection in the month before index consultation 9. Tetracycline allergy 10. Patient with bronchiectasis, cystic fibrosis or primary ciliary dyskinesia (not often seen in primary care) 11. Inability to complete the patient diary 12. Taking part in another CTIMP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time until all symptoms (cough, phlegm, shortness of breath, wheeze, blocked or runny nose, chest pain, muscle aches, headaches, disturbed sleep, general feeling of being unwell, fever and interference with normal activities) are rated as “absent” or “mild” (scoring 2 or less on a 0-6 point scale) by patients in their self-reported daily diaries | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Deterioration of illness (return to the doctor with a worsening of symptoms, new symptoms or signs, illness requiring hospital admission, or death within four weeks) measured using the self-reported patient diaries, on Days 7, 14, 21 and 28 2. Symptom severity during days 2-4 after the initial consultation (patients tell us that this is the period when their symptoms are worst) measured daily, using the self-reported patient diary 3. Antibiotic consumption over 28 days measured using patient self-reporting in a daily diary 4. Total symptom score over time by a patient measured using self-reporting in a daily diary 5. Personal costs to patients and productivity costs measured using a health economist questionnaire in the patient-reported diary at day 28 6. Health-related quality of life measured using the EuroQol EQ-5D-5L questionnaire on day 0 (day of consent), and then every 7 days until day 28 7. Time until return to usual activities (effect on usual activities rated as ‘no problem’) measured using the health-related quality of life questionnaire ] at baseline, and days 7, 14, 21 and 28 | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactStudy Team
Outcome results
None listed