Skip to content

Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis (ANTEIPA)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504755-26-00
Acronym
ANTEIPA
Enrollment
196
Registered
2024-02-20
Start date
2024-09-24
Completion date
Unknown
Last updated
2024-09-05

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

Conditions

Bronchiectasis

Brief summary

PA-eradication rate 6 months after the start of antibiotic therapy targeting PA

Detailed description

Exacerbation assessment at each follow-up visit, with time (in days) between the start of antibiotic therapy against PA and first exacerbation, Exacerbation assessment at each follow-up visit, Quality-of-life and treatment burden assessment using questionnaires, Quality of Life-Bronchiectasis (QOL-B), Bronchiectasis Impact Measure (BIM), Treatment Burden Questionnaire (TBQ) (+ EQ-5D-5L questionnaire for the medico-economic analysis), Detection of PA at 3-month and 1 year, PA-recurrence in sputum (or lower respiratory tract sample, if clinically justified), with time (in days) between the start of antibiotic therapy against PA and first PA-recurrence, Analysis of PA (or other bacteria) susceptibility to ciprofloxacin, if growing on respiratory sample(s) performed between 3 months and 12 months, AE and serious AEs will be recorded during medical interviews and by self-report in the study booklet during the study, Compliance to treatment and AEs will be recorded during medical interviews and by self-report in the study booklet during the study treatment period, time (in days), Compliance to treatment will be recorded during medical interviews and by self-report in the study booklet during the study treatment period, time (in days), Compliance to treatment will be recorded during medical interviews and by self-report in the study booklet during the study treatment period, time (in days), Total cost in each group, total quality adjusted life years (QALYs) in each group, difference in costs /difference in QALYs

Interventions

DRUGCIPROFLOXACIN
DRUGCEFTAZIDIME PENTAHYDRATE

Sponsors

Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
PA-eradication rate 6 months after the start of antibiotic therapy targeting PA

Secondary

MeasureTime frame
Exacerbation assessment at each follow-up visit, with time (in days) between the start of antibiotic therapy against PA and first exacerbation, Exacerbation assessment at each follow-up visit, Quality-of-life and treatment burden assessment using questionnaires, Quality of Life-Bronchiectasis (QOL-B), Bronchiectasis Impact Measure (BIM), Treatment Burden Questionnaire (TBQ) (+ EQ-5D-5L questionnaire for the medico-economic analysis), Detection of PA at 3-month and 1 year, PA-recurrence in sputum (or lower respiratory tract sample, if clinically justified), with time (in days) between the start of antibiotic therapy against PA and first PA-recurrence, Analysis of PA (or other bacteria) susceptibility to ciprofloxacin, if growing on respiratory sample(s) performed between 3 months and 12 months, AE and serious AEs will be recorded during medical interviews and by self-report in the study booklet during the study, Compliance to treatment and AEs will be recorded during medical interviews

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026