Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study (STOP360AG)
C
Cynthia Brown, MD
Primary Investigator
Enrolling By Invitation
6 years and older
All
Phase
4
730 participants needed
1 Location
Brief description of study
The purpose of this study is to look at pulmonary exacerbations in people with cysticbrosis (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 inwith 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 thewing questions about treating a pulmonary exacerbation:
- Do participants have the same improvement in lung function and symptoms if they ared 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?
Detailed description of study
Cystic Fibrosis Foundation (CFF) treatment guidelines for the management of pulmonarybations (PEx) identified evidence gaps in current clinical best practices. The STOPgram offers a platform for the conduct of controlled trials to develop the evidence baseder to define clinical best practices. The interventional Aminoglycoside Study (AGudy) will be a prospective, multi-center, parallel group, randomized (1:1 ratio),bel, superiority study of intravenous aminoglycoside and β-lactams versus intravenous
β-lactams only. Randomization will occur at Visit 1. The primary objective of this platformvaluate the efficacy and safety of differing treatments in CF PEx during ad 14 day course of IV antimicrobials. Primary efficacy will be evaluated as the
difference in mean Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) changesVisit 1 to Visit 2 (Day 28 ± 2 days) between intervention arms.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation
-
Age: 6 Years
-
Gender: All
Inclusion Criteria:
- 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 IVbials
- At least one documented Pa positive culture within two years prior to Visit 1
Exclusion Criteria:
- Participant is not pregnant
- No known renal impairment or history of solid organ transplantation
- No IV antimicrobial treatment, ICU admission, pneumothorax, or hemoptysis within 6weeks prior to Visit 1
- No use of investigational therapies, new CF transmembrane conductance regulator (CFTR)dulators, or treatment for Nontuberculous mycobacteria (NTM) within 4 weeks prior toVisit 1
- No history of hypersensitivity, vestibular, or auditory toxicity with aminoglycosides
- No more than one day of IV aminoglycosides administered for the current PEx treatmentVisit 1
Updated on
01 Aug 2024.
Study ID: STOP360-IP-22 AG
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