Best course of antibiotic treatment for patients with Cystic Fibrosis pulmonary exacerbation

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"Does 10 days of antibiotics work as well as 14? Help us determine what is the optimal treatment for patients with CF pulmonary exacerbation"
Age:
18 to 100 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
cystic fibrosis, pulmonary exacerbation
Type:
Drug study, Phase 4
Investigator:
Description
This study wants to answer questions about patients with cystic fibrosis (CF) who have a pulmonary exacerbation and will be treated with antibiotics given through a tube inserted into a vein (intravenously or IV). A pulmonary exacerbation is a worsening of respiratory symptoms and usually involves the use of antibiotics given either in the hospital or at home. Both doctors and CF patients have questions about the best way to treat pulmonary exacerbations. Doctors and CF patients want to make sure the patient gets antibiotics long enough to get better but don’t treat too long and expose the patient to unnecessary risks. This study is trying to answer the following questions about treating a pulmonary exacerbation:
• How long do you need to take antibiotics for a pulmonary exacerbation?
• If patients respond well to the initial antibiotic treatment, does a shorter length of treatment (10 days) with antibiotics work as well as 14 days?
• If patients don’t respond well to the initial antibiotic treatment, does a longer length of treatment (21 days) work better than 14 days?
We will collect sputum to look at the change in bacteria (or germs) during your pulmonary exacerbation. In addition, this research study collects blood and sputum to be stored for future research; this is called specimen banking. The research study will also collect some information about the costs associated with a pulmonary exacerbation for future study.
This study requires
History and physical
Blood draws
Spirometry: This test measures how much air your lungs can hold and how fast you can breathe out. You will take a deep breath and then blow into a mouthpiece as hard as you can and for as long as you can. You might have to wear soft nose clips during the test to stop air from escaping through your nose.
Questionnaires
Expectorated Sputum: Sputum is mucus from your lungs. If you are able to, we will ask you to breathe in deeply and cough hard several times to bring up sputum from deep in your chest. The samples will be collected to grow the bacteria that are present in the sputum. Any sample left over will be stored for future research (banking).
Antibiotic treatment (given at hospital or home)
Who can participate?
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
Compensation
Visit 1 $ 90
Visit 2 $ 60
Visit 3 $ 60
Resources
Schedule
Study duration and period
Three visits Up to 35 days
Recruitment period
From Feb. 20, 2017
Location
UC Davis Division of Pulmonary and Critical Care
4150 V Street
3400
Sacramento, CA 95817
Contact
Kaitlyn Kirk
Research Topic
Conditions:
  • Pulmonary Cystic Fibrosis

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