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Trial · NCT06295120

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTreatment failure at day 30From randomisation to day 30
Treatment failure is defined as any hospitalisation OR change in the antibiotic strategy (i.e., prolongation of the duration, change in antibiotic type, new antibiotic prescription) due to symptoms of acute respiratory tract infection - between randomisation and day 30.
SecondaryClinical recovery at day 8From randomisation to day 8
Clinical recovery is defined as: The participant scores below a pre-defined cut-off point for being recovered at the Acute Respiratory Tract Infection Questionnaire OR reports feeling recovered by themselves AND the participant is no longer treated with any antibiotics.
SecondaryThe Acute Respiratory Tract Infection Questionnaire (ARTIQ) scoreAt randomisation day and day 8
The Acute Respiratory Tract Infection Questionnaire is a validated, self-administered, multidimensional, sum-scaling symptom score monitoring the severity and functional impact of acute respiratory tract infections in general practice. The questionnaire consists of five single items and 37 items covering five independent dimensions: upper respiratory tract symptoms, lower respiratory tract symptoms, physiological, sleep, and medicine. The participants will be asked to evaluate each item, over the past 24 hours by using a three-point scale: "No (0 point)", "Yes - some (1 point)" or "Yes - a lot (2 points)". Ten items are dichotomized: "Yes (1 point) or "No (0 point)"). The total ARTIQ score is calculated as the sum of each dimension and single items (minimum 0 - maximum 74).
SecondaryProlonged antibiotic treatmentFrom randomisation to day 30Proportion of participants in need of prolonged antibiotic treatment.
SecondaryChange in type of antibioticFrom randomisation to day 30Proportion of participants who had prescribed another type of antibiotic treatment
SecondaryRelapse of acute Lower Respiratory Tract Infection (LRTI)From randomisation to day 30Proportion of participants with relapse of acute LRTI
SecondaryReconsultationFrom randomisation to day 30Number of reconsultations at general practice or out-off-hour services
SecondaryNew prescriptions within 30 daysFrom randomisation to day 30Proportion of participants with new prescriptions of symptomatic treatment (e.g. prednisolone, bronchodilator etc) within 30 days
SecondaryHospitalisationFrom randomisation to day 30Proportion of participants hospitalised within 30 days
SecondaryMortalityFrom randomisation to day 30All-cause mortality at day 30
SecondaryAdverse eventsFrom randomisation to day 30Proportion of participants experiencing adverse or serious adverse events
SecondaryTreatment adherenceFrom randomisation to day 8Initiation, implementation and discontinuation of the allocated treatment

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

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GET https://conductscience.org/api/trials/v1/NCT06295120/registered