Antibiotic consumption, course of therapy and costs in primary care of GP, pediatric and ENT practices

• Conditions: J02.9; H65.0; H65.1; H66.0; J00; J01; J02.8; J03.8; J03.9; J04

• Registration Number: DRKS00033456
• Lead Sponsor: Gesellschaft für Klinische Forschung e.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

Planned medication therapy due to URTI/AO infections
- Legal capacity (for children and adolescents: legal capacity of the legal guardian)
- Adults: voluntary written declaration of consent
- Adolescents between 14 and 17 years inclusive:
Voluntary written declaration of consent by the legal guardian(s) and voluntary written declaration of assent by the adolescent(s);
- Children from 6 years up to and including 13 years:
voluntary written declaration of consent by the legal guardian(s) and voluntary assent from the child documented in the patient file;
- Children from 6 months up to and including 5 years of age: voluntary written declaration of consent by the legal guardian(s)

Exclusion Criteria

- Clinically relevant concomitant diseases that inadmissibly impair the assessment of the prescription of drug therapies for the above-mentioned indications or the allocation of the documented disease and therapy-related symptoms to the same.
- Participation in another clinical trial / taking an investigational product currently or within the last 4 weeks

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relevant improvement on day 7 after practice visit (PROM)

Secondary Outcome Measures

Name	Time	Method
- Patient satisfaction with therapy on day 7 after practice visit<br>- Presence of URTI/AO symptoms > grade 1 on day 7 after practice visit <br>- Duration of illness until complete resolution of symptoms<br>- Necessary follow-up visits to the practice<br>- Frequency and severity of complications<br>- Prescription/consumption of other medications