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Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

NCT05548283 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 730

Last updated 2024-08-26

No results posted yet for this study

Summary

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?

Conditions

Interventions

DRUG

Beta-lactam antibiotic

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

DRUG

Aminoglycoside

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

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • Chris Goss

    lead OTHER

Principal Investigators

  • Patrick Flume, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-23
Primary Completion
2026-11-15
Completion
2026-11-15

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05548283 on ClinicalTrials.gov