Biomarkers of Iron Homeostasis and Responses to Cystic Fibrosis Pulmonary Exacerbation (CFPE) Treatment
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 23
Inclusion Criteria
- 1 or more hospitalizations for CFPE treatment with intravenous antibiotics within the previous year;
- Provision of signed informed-consent to study protocol;
- FEV1% greater than or equal to 75% of best measurement in previous 6 months;
- ...
- 1 or more hospitalizations for CFPE treatment with intravenous antibiotics within the previous year;
- Provision of signed informed-consent to study protocol;
- FEV1% greater than or equal to 75% of best measurement in previous 6 months;
- History of consistent sputum production on most occasions;
- Diagnosis of CF confirmed by history of positive chloride sweat test and/or CFTR mutation analysis;
- Body weight greater than or equal to 75% of best measurement in previous 6 months;
- Absence of CFPE (i.e., Akron Pulmonary Exacerbation Score <5);
- 18<Age>65
- Not admitted to hospital within the previous 3 weeks;
Exclusion Criteria
- Rescue use of oral antibiotics within the previous 3 weeks, defined as antibiotic use for health deterioration rather than chronic suppression
- Women who are pregnant or lactating;
- Subject does not meet Inclusion criteria;
- ...
- Rescue use of oral antibiotics within the previous 3 weeks, defined as antibiotic use for health deterioration rather than chronic suppression
- Women who are pregnant or lactating;
- Subject does not meet Inclusion criteria;
- Recent and/or persistent visible blood in sputum (hemoptysis);
Summary
- Conditions
- Cystic Fibrosis
- Type
- Observational
- Design
- Observational Model: Cohort
- Time Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Inclusion Criteria
- 1 or more hospitalizations for CFPE treatment with intravenous antibiotics within the previous year;
- Provision of signed informed-consent to study protocol;
- FEV1% greater than or equal to 75% of best measurement in previous 6 months;
- ...
- 1 or more hospitalizations for CFPE treatment with intravenous antibiotics within the previous year;
- Provision of signed informed-consent to study protocol;
- FEV1% greater than or equal to 75% of best measurement in previous 6 months;
- History of consistent sputum production on most occasions;
- Diagnosis of CF confirmed by history of positive chloride sweat test and/or CFTR mutation analysis;
- Body weight greater than or equal to 75% of best measurement in previous 6 months;
- Absence of CFPE (i.e., Akron Pulmonary Exacerbation Score <5);
- 18<Age>65
- Not admitted to hospital within the previous 3 weeks;
Exclusion Criteria
- Rescue use of oral antibiotics within the previous 3 weeks, defined as antibiotic use for health deterioration rather than chronic suppression
- Women who are pregnant or lactating;
- Subject does not meet Inclusion criteria;
- ...
- Rescue use of oral antibiotics within the previous 3 weeks, defined as antibiotic use for health deterioration rather than chronic suppression
- Women who are pregnant or lactating;
- Subject does not meet Inclusion criteria;
- Recent and/or persistent visible blood in sputum (hemoptysis);
Tracking Information
- NCT #
- NCT02188758
- Collaborators
- MaineHealth
- Investigators
- Not Provided
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