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Standardized Treatment of Pulmonary Exacerbations II

NCT02781610 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 982

Last updated 2021-05-19

Study results available
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Summary

Cystic fibrosis (CF), a life-shortening genetic disease, is marked by acute episodes during which symptoms of lung infection increase and lung function decreases. These pulmonary exacerbations are treated with varying antibiotics for varying time periods based on needs determined by individual patients, their families, and the health care providers. Cystic fibrosis pulmonary guidelines for the treatment of pulmonary exacerbation published by the Cystic Fibrosis Foundation (CFF) in 2009 provided recommendations for treatment and also identified key questions for which additional studies were needed.

A strong desire among clinicians to reduce treatment durations (and reduce cost, inconvenience, and potential toxicities) is in conflict with belief that patients not responding robustly to treatment might benefit from extending treatment.

This randomized, controlled, open-label study is designed to evaluate the efficacy and safety of differing durations of IV treatment, given in the hospital or at home for a pulmonary exacerbation in adult patients with CF.

Conditions

  • Pulmonary Cystic Fibrosis

Interventions

DRUG

Standard of care IV antibiotic(s)

IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • CF Therapeutics Development Network Coordinating Center

    collaborator NETWORK

  • Medical University of South Carolina

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • Chris Goss

    lead OTHER

Principal Investigators

  • Chris Goss, MD · University of Washington

  • Patrick Flume, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-03-06
Completion
2020-03-06

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

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 NCT02781610 on ClinicalTrials.gov