PRIME Trial - Primary Respiratory Infection and Microbiological Eradication Trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2026-06-09

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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.

Conditions and MedDRA coding

Bronchiectasis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Adults aged >18 years
2. Diagnosis of NCFB based on clinical symptoms and HRCT imaging within the last five years.
3. 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.
4. Clinically stable at the time of inclusion: no exacerbations in the past month and no need for intravenous medications or hospitalization.
5. Signed informed consent

Exclusion criteria 11

1. Infection with PA resistant to the treatments under investigation or infection with other bacteria
2. Patients with contraindications to the study medications (ciprofloxacin or colistin).
3. Patients with a history of intolerance to inhaled treatment via nebulization.
4. Patients with cystic fibrosis, uncontrolled asthma, tuberculosis, or immunosuppression.
5. Patients with uncontrolled systemic diseases within the last 3 months.
6. Patients receiving chronic antibiotic therapy.
7. Patients with a glomerular filtration rate < 30 ml/min/1.73 m².
8. Women of childbearing age not using a highly effective contraceptive method.
9. Pregnant or breastfeeding women.
10. Patients participating in other clinical trials.
11. Refusal to participate.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Microbiological eradication of PA, measured by negative cultures from sputum or bronchoscopic sample (only if clinically performed as part of usual care) at 3 months after treatment initiation.

Secondary endpoints 7

1. Early microbiological eradication at 1 and 2 months
2. Sustained eradication at 6 and 12 months.
3. Exacerbation frequency
4. Safety
5. Quality of life
6. Serum biomarkers levels
7. Costs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Sponsor organisation

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Address

Calle Sant Quinti 77-79

City

Barcelona

Postcode

08041

Country

Spain

Scientific contact point

Organisation

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Contact name

Rosa M. Antonijoan Arbos

Public contact point

Organisation

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Contact name

Rosa M. Antonijoan Arbos

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications