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Induction of Macrolide Resistance Post Azithromycin or Erythromcyin Treatment

intensity of induction of Macrolide Resistance Post Azithromycin or Erythromcyin Treatment in healthy participants

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000278336
Acronym
The IMPACT trial
Enrollment
60
Registered
2017-02-23
Start date
2017-03-31
Completion date
2017-03-31
Last updated
2017-03-13

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

Conditions

None listed

Brief summary

to determine whether in normal healthy volunteers without recent antibiotic exposure, one month of daily erythromycin treatment will induce lower rates of macrolide resistance in commensal oropharyngeal flora than one month of daily azithromycin

Interventions

60 participants will be recruited and randomly assigned to receive either azithromycin (125mg) twice per day or Erythromycin ethylsuccinate 400mg twice per day for 4 weeks orally. adherence to therapy will be monitored by counting the number of tablets retuned after one week and 4 weeks. 80% adherence to therapy will be considered compliant.

Sponsors

Mater misericordiae Ltd, South Brisbane
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Consenting individual Non-smoker Nil antibiotics for 3 months prior to study enrolment; no macrolide antibiotic for 12 months Nil current illness Ability to provide a consenting close cohabitant Cohabitant defined as someone who has more than 4 hours of interaction with the index case on at least 5 days per week

Exclusion criteria

Smoking Chronic lung disease including asthma if on corticosteroids Use of any antibiotic within the preceding 3 months Use of any Macrolide antibiotic within the preceding 12 months Current use of any antibiotic Respiratory tract illness within the preceding 1 month current respiratory tract illness

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 12, 2026