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PRIME Trial - Primary Respiratory Infection and Microbiological Eradication Trial
EU CTIS ID: 2025-524454-34-00
What this study is testing
The primary objective of this study is to evaluate the efficacy of three different antibiotic regimens, compared to placebo, for the eradication of PA in adults with NCFB and primary PA infection. The primary outcome will focus on microbiological eradication, which will be assessed through negative cultures at 3 months after treatment initiation.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults aged >18 years
- Diagnosis of NCFB based on clinical symptoms and HRCT imaging within the last five years.
- Primary PA infection, identified by isolation of PA from a respiratory sample, meeting one of the following criteria: -First isolation: The patient has never had a positive culture for PA from a respiratory sample* before. -PA persistence: The patient had a first isolation of PA from a respiratory sample during an exacerbation, followed by systemic antibiotic treatment (oral or intravenous), with PA persisting in a respiratory sample four weeks after the completion of treatment. -New isolation: The patient had a prior positive culture for PA from a respiratory sample, with at least three negative cultures for PA over the preceding year (spaced at least one month apart) without chronic antipseudomonal treatment during this period. * Respiratory sample: sputum or bronchoscopic sample obtained during routine clinical practice.
- Clinically stable at the time of inclusion: no exacerbations in the past month and no need for intravenous medications or hospitalization.
- Signed informed consent
You likely can't join if
- Infection with PA resistant to the treatments under investigation or infection with other bacteria
- Patients participating in other clinical trials.
- Refusal to participate.
- Patients with contraindications to the study medications (ciprofloxacin or colistin).
- Patients with a history of intolerance to inhaled treatment via nebulization.
- Patients with cystic fibrosis, uncontrolled asthma, tuberculosis, or immunosuppression.
See the full eligibility criteria
- Adults aged >18 years
- Diagnosis of NCFB based on clinical symptoms and HRCT imaging within the last five years.
- Primary PA infection, identified by isolation of PA from a respiratory sample, meeting one of the following criteria: -First isolation: The patient has never had a positive culture for PA from a respiratory sample* before. -PA persistence: The patient had a first isolation of PA from a respiratory sample during an exacerbation, followed by systemic antibiotic treatment (oral or intravenous), with PA persisting in a respiratory sample four weeks after the completion of treatment. -New isolation: The patient had a prior positive culture for PA from a respiratory sample, with at least three negative cultures for PA over the preceding year (spaced at least one month apart) without chronic antipseudomonal treatment during this period. * Respiratory sample: sputum or bronchoscopic sample obtained during routine clinical practice.
- Clinically stable at the time of inclusion: no exacerbations in the past month and no need for intravenous medications or hospitalization.
- Signed informed consent
- Infection with PA resistant to the treatments under investigation or infection with other bacteria
- Patients participating in other clinical trials.
- Refusal to participate.
- Patients with contraindications to the study medications (ciprofloxacin or colistin).
- Patients with a history of intolerance to inhaled treatment via nebulization.
- Patients with cystic fibrosis, uncontrolled asthma, tuberculosis, or immunosuppression.
- Patients with uncontrolled systemic diseases within the last 3 months.
- Patients receiving chronic antibiotic therapy.
- Patients with a glomerular filtration rate < 30 ml/min/1.73 m².
- Women of childbearing age not using a highly effective contraceptive method.
- Pregnant or breastfeeding women.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.