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Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

ConditionsCystic FibrosisCystic Fibrosis Pulmonary Exacerbation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6+
SponsorChris Goss

About this trial

The purpose of this study is to look at pulmonary exacerbations in people with cystic fibrosis (CF) that need to be treated with antibiotics given through a tube inserted into a vein (intravenous or IV). A pulmonary exacerbation is a worsening of respiratory symptoms in people with CF that needs medical intervention. Both doctors and CF patients are trying to understand the best way to treat pulmonary exacerbations. This study is trying to answer the following questions about treating a pulmonary exacerbation:

* Do participants have the same improvement in lung function and symptoms if they are treated with one type of antibiotic (called beta-lactams or β-lactams) versus taking two different types of antibiotics (tobramycin and β-lactams)? * Is taking one type of antibiotic just as good as taking two types?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All genders ≥ 6 years of age at Visit 1

Documentation of a CF diagnosis

Clinician intent to treat index CF PEx with a planned 14-day course of IV antimicrobials

At least one documented Pa positive culture within two years prior to Visit 1

Disqualifiers

Participant is not pregnant

No known renal impairment or history of solid organ transplantation

No IV antimicrobial treatment, ICU admission, pneumothorax, or hemoptysis within 6 weeks prior to Visit 1

No use of investigational therapies, new CF transmembrane conductance regulator (CFTR) modulators, or treatment for Nontuberculous mycobacteria (NTM) within 4 weeks prior to Visit 1

Trial design

Design model

Parallel

Treatments tested in this trial

  • Beta-lactam antibiotic

    Drug

    Intravenous (IV) β-lactam will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days).

  • Aminoglycoside

    Drug

    Intravenous (IV) aminoglycoside will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days).

Treatment groups

730 Participants
are divided into 2 treatment groups
Group A: β-lactam Only (Non-AG)Other 1 intervention
Group B: β-lactam and Aminoglycoside (AG)Other 2 interventions

Trial outcomes

Primary outcomes

1

Absolute Change in FEV1 % Predicted at Week 4 in Aminoglycoside (AG) Study

Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the absolute change in FEV1 % predicted from Week 0 (Day 0) to Week 4 (Day 28 ± 2 days)

Time frame
Four weeks
2

Incidence of Adverse Events (AEs) in Aminoglycoside (AG) Study Intervention Arms

Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the proportion of participants with at least one AE from Week 0 (Day 0) to Week 6 (Day 44 ± 2 days).

Time frame
Six Weeks

Secondary outcomes

1

Absolute Change in CFRSD-CRISS Score at Week 4 in Aminoglycoside (AG) Study

Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the absolute change in respiratory symptoms, as measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) from Week 0 (Day 0) to Week 4 (Day 28 ± 2 days). The CFRSD-CRISS is derived from a set of questions asking a participant to state the extent of their 8 respiratory symptoms: difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms.

Time frame
Four weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chris Goss

Lead sponsor

Seattle Children's Hospital

Sponsor institution

University of Washington

Collaborator

Medical University of South Carolina

Collaborator

Cystic Fibrosis Foundation

Collaborator

Source ClinicalTrials.gov
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