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Not yet recruitingPhase 4

PRIME Trial - Primary Respiratory Infection and Microbiological Eradication Trial

Key facts

Who runs it
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Where
Spain13 sites in 1 countryChoose a country to see its sites
Status
Not yet recruiting
Phase
Phase 4
People taking part
160 people, planned
Started
1 Apr 2026
Expected to end
1 Mar 2029
Type of study
Interventional
Record updated
9 June 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patients with contraindications to the study medications (ciprofloxacin or colistin)
  • Patients receiving chronic antibiotic therapy
  • Infection with PA resistant to the treatments under investigation or infection with other bacteria
  • 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
  • Women of childbearing age not using a highly effective contraceptive method
  • Patients participating in other clinical trials
  • Refusal to participate
  • Patients with a glomerular filtration rate < 30 ml/min/1.73 m²
  • Pregnant or breastfeeding women

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Randomized, double-blind, parallel-group clinical trial, compared with placebo to evaluate the efficacy and safety of three antibiotic treatment regimens for the eradication of primary P. aeruginosa infection in patients with bronchiectasis
Record updated
9 June 2026