Phase 4
Completed N=982
Standardized Treatment of Pulmonary Exacerbations II
Pulmonary Cystic Fibrosis
Source: ClinicalTrials.gov NCT02781610 ↗
Enrolled (actual)
982
Serious AEs
4.4%
Results posted
Apr 2021
Primary outcomePrimary: Absolute Change in FEV1 % Predicted From Visit 1 to Visit 3 Between ERR-10 Day and ERR-14 Day — 13.30; 13.83 percentage change — p=0.0164
◆ Published Evidence
Established
91citations · ~18 / year
A Randomized Clinical Trial of Antimicrobial Duration for Cystic Fibrosis Pulmonary Exacerbation Treatment.
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.
Linked Publications (5)
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A Randomized Clinical Trial of Antimicrobial Duration for Cystic Fibrosis Pulmonary Exacerbation Treatment.
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C-reactive protein (CRP) as a biomarker of pulmonary exacerbation presentation and treatment response.
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Prevalence and Clinical Impact of Respiratory Viral Infections from the STOP2 Study of Cystic Fibrosis Pulmonary Exacerbations.
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Adjunctive Systemic Corticosteroids for Pulmonary Exacerbations of Cystic Fibrosis.
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Health care costs in a randomized trial of antimicrobial duration among cystic fibrosis patients with pulmonary exacerbations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in FEV1 % Predicted From Visit 1 to Visit 3 Between ERR-10 Day and ERR-14 Day |
13.30; 13.83 | 0.0164 sig |
| PRIMARY Absolute Change in FEV1 % Predicted From Visit 1 to Visit 3 Between NERR-14 Day and NERR-21 |
3.60; 3.53 | 0.568 |
| SECONDARY Change in CRISS From Visit 1 to Visit 3 Between ERR-10 Day and ERR-14 Day |
-24.2; -25.3 | 0.546 |
| SECONDARY Change in CRISS From Visit 1 to Visit 3 Between NERR-14 Day and NERR-21 Day |
-15.1; -16.7 | 0.140 |
| SECONDARY Change in Weight From Visit 1 to Visit 3 Between ERR-10 Day and ERR-14 Day |
1.7; 1.5 | 0.563 |
| SECONDARY Change in Weight From Visit 1 to Visit 3 Between NERR-14 Day and NERR-21 Day |
0.5; 0.8 | 0.083 |
Eligibility Criteria
Inclusion Criteria
Key Inclusion Criteria
- Male or female ≥18 years of age at Visit 1
- Documentation of a CF diagnosis
- Enrolled in the Cystic Fibrosis Foundation National Patient Registry (CFFNPR) prior to Visit 1 (US sites only)
- At the time of Visit 1, there is a plan to initiate IV antibiotics for a pulmonary exacerbation
- Performed spirometry at Visit 1 and Visit 2 and willing to perform spirometry at Visit 3
- Completed the CRISS questionnaire at Visit 1 and Visit 2 and willing to complete the Cystic Fibrosis Respiratory Symptoms Diary (CFRSD) questionnaire at Visit 3
- Willing to adhere to a specific treatment duration determined by initial response to treatment and subsequent randomization
- Willing to return for follow up Visit 3
- Written informed consent obtained from the subject or subject's legal representative
Exclusion Criteria
Key Exclusion Criteria
- Previous randomization in this study
- Treatment with IV antibiotics in the 6 weeks prior to Visit 1
- Admission to the intensive care unit for current pulmonary exacerbation in the two weeks prior to Visit 2, unless admission was due to a desensitization protocol
- Pneumothorax in the two weeks prior to Visit 2
- Primary diagnosis for current hospitalization is unrelated to worsening lower respiratory symptoms (e.g., pulmonary clean out, distal intestinal obstruction syndrome (DIOS), sinusitis)
- Massive hemoptysis defined as > 250 cc in a 24 hour period or 100 cc/day over 4 consecutive days occurring in the two weeks prior to Visit 2
- Current pulmonary exacerbation thought to be due to allergic bronchopulmonary aspergillosis (ABPA)
- At Visit 1, receiving ongoing treatment with a duration of more than 2 weeks with prednisone equivalent to >10mg/day
- History of solid organ transplantation
- Receiving antimicrobial therapy to treat non-tuberculous mycobacterium (e.g., M. abscessus, M. avium complex) in the two weeks prior to Visit 2
Data sourced from ClinicalTrials.gov (NCT02781610) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.