Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

Conditions

• Cystic Fibrosis
• Cystic Fibrosis Pulmonary Exacerbation

Eligibility Criteria

Sex

ALL

Age

6 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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).

Study Details

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?

Key Dates

Start date

Apr 23, 2023

Status verified

Aug 2024

Primary completion

Nov 15, 2026

Completion

Nov 15, 2026

Study Design

Enrollment

730 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: β-lactam Only (Non-AG)
  Participants randomized to this arm will be prescribed a standard of care intravenous (IV) β-lactam as selected by their treating physician. Treatment must not include an IV aminoglycoside.
• Other: β-lactam and Aminoglycoside (AG)
  Participants randomized to this arm will be prescribed a standard of care intravenous (IV) β-lactam and aminoglycoside selected by their treating physician.

Primary Outcome Measure

Absolute Change in FEV1 % Predicted at Week 4 in Aminoglycoside (AG) Study [ Time Frame: Four weeks ]

Central Contacts

• Rachael Buckingham, BS
  206-884-7517
  [email protected]
• Barbra Fogarty
  206-884-7592
  [email protected]

Locations (59)

Find similar trials in Birmingham, AL

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