Rapid respiratory microbiological point-of-care-testing in primary care (RAPID-TEST trial)

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: Participants will need to provide a nose and throat swab sample. Participants will be individually randomised 1:1 to intervention (GP POCTRM test) or control (No GP POCTRM test) using an internet‐based randomisation system developed and maintained by Sealed Envelope™. For participants randomised to the GP POCTRM Test group, a portion of their swab sample will be analysed immediately using the BioFire® FilmArray® Torch 1 machine. The remaining swab sample from participants in the GP POCTRM Test group and the whole swab sample from participants in the No GP POCTRM Test group will be transferred within 24 hours to the central research laboratory. For participants randomised to GP POCTRM Test, the Study Clinician will wait to receive the result of the POCTRM before deciding whether any antibiotic treatment is required. For participants randomised to No GP POCTRM Test, a decision on whether antibiotic treatment is required can be made immediately. CONDITION: Respiratory infection ; Respiratory PRIMARY OUTCOME: Antibiotic prescribing (including delayed prescribing) for a RTI at Appointment Two SECONDARY OUTCOME: ; 1. Mean symptom severity on Days 2 to 4; Timepoint(s): Days 2 to 4;; 2. Participant Views; Timepoint(s): Day 1 and 2 Months;; 3. Last day on which any symptom was recorded as “moderately bad” or worse; Timepoint(s): Up to Day 28;; 4. Length of time to return to usual activities; Timepoint(s): Up to Day 28;; 5. Last day prior to all symptoms recorded as zero for two consecutive days ; Timepoint(s): Up to Day 28;; 6. Any new symptoms or worsening of pre‐existing symptoms ; Timepoint(s): Up to Day 28;; 7. Documentation of any RTI related consultation (in and out of normal office hours) after Appointment Two and =28 days, whether for the same symptoms /illness as the recruitment consultation with/out documentation that symptoms are getting worse; Timepoint(s): Up to Day 28;; 8. Evidence of any hospital admission for a respiratory infection in the medical records =28 days; Timepoint(s): 2 Months;; 9. Name, strength, frequency and quantity of antibiotics and antivirals prescribed after Appointment Two and =28 days; Timepoint(s): 2 Months;; 10. Name of antibiotic and antiviral, and number of times per day the medicine was consumed; Timepoint(s): Up to Day 28;; 11. Documentation of any consultation (in and out of normal office hours) =6 months for a RTI; Timepoint(s): 6 months;; 12. Participant responses to qualitative questions; Timepoint(s): During optional interview;; 13. Discrete choice experiment (DCE) survey ; Timepoint(s): During optional survey;; 14. Clinician responses to qualitative questions; Timepoint(s): During optional interview;; 15. Clinician DCE survey; Timepoint(s): During optional survey;; 16. Clinician views; Timepoint(s): Day 1;; 17. Central research laboratory POCTRM result; Timepoint(s): By end of trial;; 18. Central research laboratory extended testing ; Timepoint(s): By end of trial;; 19. EQ‐5D‐5L and EQ‐5D‐Y ; Timepoint(s): Up to Day 28; INCLUSION CRITERIA: 1. Aged >=12 months on the day of presentation to primary care. 2. Presenting to primary care for the first time in this episode, and within 21 days of illness onset, with a Study Clinician suspected acute respiratory infection. Symptoms may include one or more of: 2.1. Sore throat 2.2. Runny nose 2.3. Earache 2.4. Cough 2.5. Sputum 2.6. Wheeze 2.7. Shortness of breath 3. Study Clinician diagnoses of an upper or lower RTI such as: 3.1. Acute otitis media 3.2. Acute sinusitis 3.3. Acute pharyngitis or tonsillitis 3.4. Sore throat 3.5. Acute laryngitis 3.6. Acute cough 3.7. Acute bronchitis 3.8. Chest infection 3.9. Acute lower RTI 3.10. Infective exacerbation of chronic lung disease e.g. asthma, chronic obstructive pulmonary disease (COPD), emphysema or bronchiectasis 4. Study Clinician or patient/parent/carer believes an
Epistemonikos ID: 529fa9e6506bad85b3f1da6220299938bdba3521
First added on: Nov 09, 2022