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Sustainable reduction of antibiotics-induced antimicrobial resistance (ARena) in German ambulatory care

Sustainable reduction of antibiotics-induced antimicrobial resistance (ARena) in German ambulatory care: a cluster randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN58150046
Enrollment
30000
Registered
2017-09-13
Start date
2017-09-01
Completion date
Unknown
Last updated
2022-10-03

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

Conditions

Non-complicated infections like upper respiratory tract infections, bronchitis, sinusitis, tonsillitis, and otitis media, and community acquired pneumonia and non-complicated cystitis Infections and Infestations

Interventions

Non-blinded cluster randomized trial with three arms and an added cohort that reflects usual care in 14 practice networks in two German federal states (Bavaria and North Rhine-Westphalia) with an addi

Sponsors

Federal Joint Committee (G-BA), Innovation Fund
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthcare professionals need to be part of one of the 14 participating practice networks in Bavaria and North Rhine-Westphalia and belong to one of the following medical specialist groups (Facharztgruppen, FG): GPs (Allgemeinmediziner, Hausarzt, hausätzlich tätiger Internist: FG 01, 02, 03), internists (Internist: FG 23), gynaecologists (Gynäkologe: FG 15, 18), ENT physicans (HNO-Arzt: FG 19), urologists (Urologe: FG 67), respiratory physicians (Pneumologe: FG 30,39,45), and paediatricians (Kinderarzt: FG 34, 40, 46) 2. Patients aged over 18, diagnosed with upper respiratory tract infections, acute bronchitis, sinusitis, tonsillitis, otitis media, non-complicated cystitis, or community acquired pneumonia by physicians in participating ambulatory practices and registered at AOK health insurance in Bavaria or North Rhine-Westphalia, Germany

Exclusion criteria

Exclusion criteria: Participants younger than 18 years and without German language skills will be excluded from survey and interviews

Design outcomes

Primary

MeasureTime frame
Antibiotics prescription rate in patients with non-complicated acute infections (upper respiratory tract infections, bronchitis, sinusitis, tonsillitis, and otitis media) within the three intervention arms, extracted from pseudonymized claims data each quarter year

Secondary

MeasureTime frame
Extracted from pseudonymized claims data each quarter year: 1. Use of antibiotics in ambulatory care in defined daily dose (DDD) per 1000 residents (respectively insured persons) per day and region 2. % of defined daily dose (DDD) of (a) broad-spectrum quinolones of all used antibiotics and (b) broad-spectrum cephalosporins (3rd and 4th generation) of all used antibiotics 3. % of patients (18-75 years) with acute bronchitis, patients (> 18 years) with sinusitis, patients (> 2 years) with otitis media and patients (> 1 year) with upper respiratory tract infections/tonsillitis with a prescription of (a) recommended antibiotics, if necessary at all, but (b) less broad-spectrum antibiotics like quinolones 4. % of women (> 18 years) with a diagnosis of non-complicated cystitis and a prescription of (a) antibiotics, (b) recommended antibiotics but (c) less broad-spectrum antibiotics like quinolones 5. % of patients (18-65 years) with community acquired pneumonia and a prescription of (a) antibiotics, (b) recommended antibiotics, (c) less broad-spectrum antibiotics like quinolones and (d) less broad-spectrum antibiotics like cephalosporins or macrolides 6. % of patients with non-complicated infections who use medical emergency service 7. % of patients with community-acquired pneumonia and hospitalization The process evaluation covers (a) the uptake and perceived impact of intervention components by participants with a focus on handling patients with non-complicated infections, (b) the perceived impact of contextual factors, particularly those related to practice networks, and (c) perceptions of patients’ expectations regarding antibiotics prescribing.

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026