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Anti-Infective Completed with Results
STOP 2: Treatment of pulmonary exacerbations in people with CF (STOP2-IP-15)
This study evaluated the safety and effectiveness of different lengths of intravenous (IV) treatment for pulmonary exacerbations in people with CF.
This study was for people with CF who experience a pulmonary exacerbation and were to receive IV antibiotic treatment. In this study, participants were randomly assigned to an IV treatment duration 7-10 days after they started IV treatment. Participants were categorized as responding early to IV treatment if they had a lung function improvement of at least 8% (ppFEV1) and a decrease of at least 11 points in the chronic respiratory infection symptom score questionnaire (CRISS). Early responders were randomly assigned to receive 10 or 14 days of total antibiotic treatment. Participants were categorized as not responding early to IV treatment if they did not meet both those criteria. These participants were randomly assigned to receive a total of 14 or 21 days of total antibiotic treatment. For both groups, providers were provided guidance on which antibiotics to give to participants.
Eligibility
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Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Study Results
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What We Learned:
This study found that in people with CF who experience a pulmonary exacerbation and received IV antibiotic treatment, when comparing differences in lung function improvement, 10 days of treatment was no worse than 14 days of antibiotic treatment among those who respond early to treatment. Also, among those slower to respond, 21 days of treatment was not significantly better than 14 days of antibiotic treatment when it comes to lung function improvements.
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Primary Findings:
Effectiveness:
This study was conducted between July 2016 and January 2020. The study enrolled and randomized 982 participants. Of the 982 participants, 277 were in the early responder group and 705 were in the non-early responder group. In the early responder group, 140 were randomly assigned to 10 days of IV antibiotic treatment and 137 to 14 days. In the non-early responder group, 353 were randomly assigned to 14 days and 352 were assigned to 21 days.
The primary efficacy outcome was improvement in lung function, as measured by ppFEV1 from start of IV antibiotics to 2 weeks after end of scheduled IV antibiotic duration. In the early responder group, mean change ppFEV1 was 12.8 percentage points for the 10 day duration and 13.4 percentage points ppFEV1 for the 14 day duration arm. The difference in change in lung function between 10 days and 14 days was not clinically significantly different (difference -0.7, 95% CI [CI -3.3 to 2.0], p=0.016, excluding the predefined non-inferiority margin).
In the non-early responder group lung function improved but the overall improvement was less than what was seen in the early responder group. Participants receiving 14 days of antibiotics experienced a 3.4 ppFEV1 improvement in lung function while those receiving 21 days achieved a 3.3 ppFEV1 improvement. By pre-defined criteria, 21 days is not considered superior to 14 days in terms of lung function response.
Respiratory symptoms improved as measured by the CRISS in all treatment duration groups, with no significant differences between duration assignment arms. Additionally, weight increased in all duration groups at the end of the treatment period, with no significant differences. There were no significant differences in the need to be treated again for a pulmonary exacerbation within 30 days or time to next pulmonary exacerbation across the duration assignments.
Safety:
There was no difference in the number of adverse events (AEs) seen in the 10 versus 14 day durations in the early responder group. In the non-early responder group, there were more AEs seen in the 21 day duration group compared with the 14 day duration (73 versus 40 respectively), with gastrointestinal disorders, fever and elevated liver function tests being the most common AEs.
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Citation:
Am J Respir Crit Care Med 2021;DOI 10.1164/rccm.202102-0461OC
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
No -
Length of Participation:
35 days -
Number of Study Visits:
3
Additional Information
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Phase: ?more info
Not Applicable -
Study Sponsor: ?more info
Flume, Patrick -
Study Drugs:
N/A
Eligibility
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
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