Respiratory tract infections in primary care

Converting habits of antibiotic prescribing for respiratory tract infections in German primary care: the randomized controlled CHANGE-2 trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN01559032

Enrollment

188

Registered

2012-09-10

Start date

2012-10-01

Completion date

Unknown

Last updated

2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory tract infection (RTI) Respiratory Unspecified acute respiratory infection

Interventions

Clusters will consist of participating primary care physicians and their patients. Physicians will be randomized into three groups: 1. Intervention A (communication training)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The trial includes general practitioners and practice-based pediatricians and their patients, who ask for consultation due to acute respiratory infection. Patient inclusion criteria are: 1. Health insurance with the AOK, a statutory health insurance that covers more than 50% of the population in the study regions 2. Three months minimum age 3. Physician consultation visit due to the first episode of acute RTI (upper respiratory infection (URTI) and lower respiratory infection (LRTI)) according to the ICD classes: J00-J04, J06, J13, J20, J22, otherwise healthy. This definition will include all typical acute RTI including bronchitis, tonsillopharyngitis (e.g. sore throat), and otitis media. Participants are required to give informed consent that includes the acceptance of scientific use of relevant data stored at the AOK. This data will include the period of 12 months before and 6 weeks after recruitment into the study

Exclusion criteria

Exclusion criteria: 1. Underlying chronic diseases, which may affect the immune status in any relevant matter (e.g. malignoma, chronic obstructive pulmonary diseases, cystic fibrosis, immune deficiency of other causes) 2. Patients who are not able to give informed consent 3. Patients who require hospital care

Design outcomes

Primary

Measure	Time frame
Physicians' antibiotic prescription rate for RTI derived from data of the statutory health insurance AOK that covers more than 50 % of the population in the study regions	—

Secondary

Measure	Time frame
1. Re-consultation rate 2. Use of medical services 3. Hospital admissions	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 24, 2026