Covid 19 Research using Clinical Trials (Home Page)
Report for D003550: Cystic Fibrosis NIH
(Synonyms: Cystic F, Cystic Fi, Cystic Fibros, Cystic Fibrosi, Cystic Fibrosis)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (11)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug653 | Chlorhexidine Gluconate Wiki | 0.50 |
| drug509 | CFTR Modulators Wiki | 0.50 |
| drug2972 | Trimethoprim Sulfamethoxazole (TMP/SMX) Wiki | 0.50 |
| drug1794 | Mupirocin Wiki | 0.50 |
| drug1768 | Minocycline Wiki | 0.50 |
| drug1014 | Environmental Decontamination Wiki | 0.50 |
| drug3015 | Unsupervised exercise Wiki | 0.50 |
| drug551 | COVID-19 Therapeutic Vaccine - Nucleocapsid-GM-CSF Protein Lactated Ringer's Injection Wiki | 0.35 |
| drug1035 | Exercise Wiki | 0.35 |
| drug1461 | Interview Wiki | 0.29 |
| drug2311 | Questionnaire Wiki | 0.10 |
Correlated MeSH Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D005355 | Fibrosis NIH | 0.57 |
| D055732 | Pulmonary Aspergillosis NIH | 0.50 |
| D001229 | Aspergillosis, Allergic Bronchopulmonary NIH | 0.50 |
| D009181 | Mycoses NIH | 0.35 |
| D001228 | Aspergillosis NIH | 0.35 |
| D003141 | Communicable Diseases NIH | 0.04 |
| D007239 | Infection NIH | 0.03 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 4 clinical trials
Clinical Trials
1 STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)
To evaluate the micro-biologic efficacy and safety of a streamlined treatment for early onset methicillin-resistant staphylococcus aureus (MRSA) in patients with cystic fibrosis.
NCT03489629 Cystic Fibrosis Drug: Trimethoprim Sulfamethoxazole (TMP/SMX) Drug: Minocycline Drug: Mupirocin Drug: Chlorhexidine Gluconate Behavioral: Environmental Decontamination MeSH:Cystic Fibrosis
Primary Outcomes
Description: Descriptive summary with corresponding 95% confidence interval.
Measure: Proportion of STAR-TER subjects with a negative MRSA culture at Day 28 vs. observational arm of historic STAR-Too trial Time: Day 28Secondary Outcomes
Description: Pulmonary exacerbation is defined as having 1 of the major criteria or 2 minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Measure: Proportion of subjects with a protocol-defined pulmonary exacerbation between Baseline and Day 28 treated with antibiotics active against MRSA Time: Period ranging from start of Baseline and continuing through Day 28Description: Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Measure: Proportion of subjects with a protocol-defined pulmonary exacerbation between Baseline and Day 28 treated with any oral, inhaled, or IV antibiotics regardless of potential activity against MRSA Time: Period ranging from start of Baseline and continuing through Day 28Measure: Proportion of subjects treated with oral, inhaled, and IV antibiotics over the six-month study Time: Period ranging from start of Baseline and continuing through Month 6
Description: Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Measure: Time to protocol-defined pulmonary exacerbation over the six-month study Time: Period ranging from start of Baseline and continuing through Month 6Description: Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration. Major criteria: Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1 New lobar infiltrate(s) or atelectasis on chest radiograph Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: Increased work of breathing or respiratory rate New or increased adventitial sounds on lung exam Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months Increased cough Decreased exercise tolerance or level of activity Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Measure: Number of protocol-defined pulmonary exacerbations over the six-month study Time: Period ranging from start of Baseline and continuing through Month 6Description: Proportion of subjects with a negative culture for MRSA at Day 56
Measure: MRSA Culture Status Time: Day 56Description: Compliance refers to the amount of prescribed medication consumed.
Measure: Proportion of subjects with >80% compliance for study drug during the first 28 days Time: Day 282 Combined Effect of CFTR Protein Modulator Drugs and Exercise on Pulmonary Function, Fitness, Sweat Test and Quality of Life in Children With Cystic Fibrosis
This study aims to assess the effects of programmed exercise combined with CFTR protein modulator drugs in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis.
NCT04415268 Cystic Fibrosis in Children Behavioral: Exercise Behavioral: Unsupervised exercise Drug: CFTR Modulators MeSH:Cystic Fibrosis Fibrosis
Primary Outcomes
Description: Changes in strength will be measured using a five repetition maximum test (5RM)
Measure: Change in Strength Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in cardiorespiratory fitness will be measured using a cardiopulmonary exercise test (CPET)
Measure: Change in Cardiorespiratory Fitness Time: Four assessment points throughout the study: baseline and after each 8-week interventionSecondary Outcomes
Description: Changes in FEV1 will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in Forced expiratory volume in 1 second (FEV1) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FVC will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in Forced vital capacity (FVC) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FEV1/FVC ratio (FEV1%) will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in FEV1/FVC ratio (FEV1%) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FEF will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in Forced expiratory flow (FEF) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in physical activity levels will be measured using PAQ-C for children under 14 years of age and PAQ-A for adolescents over 14 years of age. Items 1 to 9 will be used in the physical activity composite score, and means will be calculated to obtain the final PAQ-C activity summary score. Items 1 to 8 will be used in the physical activity composite score, and means will be calculated to obtain the final PAQ-A activity summary score. A score of 1 indicates low physical activity, whereas a score of 5 indicates high physical activity.
Measure: Changes in Physical Activity Questionnaire (PAQ) for children and adolescents Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in quality of life will be measures with the Cystic Fibrosis-Questionnaire-Revised (CFQ-R). Scores for each health related quality of life domain are calculated; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.
Measure: Change in quality of life: Cystic Fibrosis-Questionnaire-Revised (CFQ-R) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Chloride concentration in sweat (mEq/L) will be measured in the laboratory using an MK II Chloride Analyzer 926S
Measure: Sweat chloride level Time: Four assessment points throughout the study: baseline and after each 8-week intervention3 Impacts of the Covid-19 Epidemic and Associated Lockdown Measures on the Management, Health and Behaviors of Cystic Fibrosis Patients During the 2020 Epidemic
Impacts of the Covid-19 epidemic and associated lockdown measures on the management, health and behaviors of cystic fibrosis patients during the 2020 epidemic
NCT04463628 Cystic Fibrosis in Children Cystic Fibrosis Behavioral: Questionnaire Behavioral: Interview MeSH:Cystic Fibrosis Fibrosis
Primary Outcomes
Description: Number of consultations cancelled or postponed by the health professional or patient of consultations (medical and paramedical),
Measure: Cancellation or postponement of consultations by the health professional or patient, Time: Up to 6 monthsDescription: Number of consultations cancelled by the teleconsultation/replacement patient,
Measure: Patient cancellation of teleconsultations/telecare replacement, Time: Up to 6 monthsDescription: Number of consultations cancelled or postponed by the health care institution or by the patient of hospitalizations (acute or scheduled)
Measure: Cancellation or postponement by the health care institution or by the patient of hospitalizations (scheduled or unscheduled), Time: Up to 6 monthsDescription: Number of patients affected by the change in the modality of administration of antibiotic cures (intravenous instead of intravenous administration).
Measure: Change in the modalities of administration of antibiotics cures (oral instead of intravenous administration). Time: Up to 6 monthsSecondary Outcomes
Description: Cancellation or postponement by the patient of consultations (medical or paramedical) Patient cancellation of teleconsultations/telecare proposed by the health professional Cancellation or postponement by the patient of hospitalizations (acute or scheduled)
Measure: The reduction of each of the elements of care provision and health care utilization: Time: Up to 6 monthsDescription: Intravenous instead of intravenous administration
Measure: The change of modality of administration of antibiotic cures Time: Up to 6 monthsDescription: Questionnaire about taking or not taking treatment during confinement
Measure: Compliance Time: Up to 6 monthsDescription: Scale 0-21
Measure: Anxiety and stress (at risk of being affected by COVID-19 or at risk of being treated less well) Time: Up to 6 monthsDescription: A questionnaire on the presence or absence of toxic consumption
Measure: Presence or absence of toxic consumption (drug, alcohol) during the lockdown Time: Up to 6 monthsDescription: Experience and social representations of confinement by cystic fibrosis patients (evaluated by qualitative methods)
Measure: Evaluation of the knowledge, experience and social representations of the risk of Covid-19 Time: Up to 6 monthsDescription: Role of social inequalities in the consequences of containment assessed by qualitative methods
Measure: Assessing the role of social inequalities in the consequences of lockdown Time: Up to 6 monthsDescription: Prevalence of suspected and/or confirmed Covid-19 infections in patients with cystic fibrosis
Measure: Suspected and/or confirmed Covid-19 in patients with cystic fibrosis. Time: Up to 6 months4 Immune Profiles in CF Fungal Infection
This study is investigating the role of allergic (Th2) inflammation in patients with Cystic Fibrosis (CF) and history of fungal infection and/or Allergic Bronchopulmonary Aspergillosis. Little is known about fungal infection in CF and conflicting results exist on whether this results in worse lung function over time. There is concern that persistent fungal infection can result in worse clinical outcome measures in patients with CF. Also, it is unclear how ABPA develops, but may be related to the amount of fungus a patient with CF is infected with. This study looks at inflammatory patterns and allergic responses to fungal elements to help identify biomarkers and signs of allergic disease in fungally infected patients with CF.
NCT04476758 Cystic Fibrosis Fungal Infection Allergic Bronchopulmonary Aspergillosis MeSH:Infection Communicable Diseases Mycoses Aspergillosis Pulmonary Aspergillosis Aspergillosis, Allergic Bronchopulmonary Cystic Fibrosis Fibrosis
Primary Outcomes
Description: Difference in sputum Th2 biomarkers (ECP, IL4, IL5, IL10, IL13, and eosinophil count) in patients with CF with fungal infection with expected elevation of sputum Th2 biomarkers in patients with CF and ABPA compared to those without fungal infection and without ABPA.
Measure: Difference in Th2 Sputum Markers Time: Average of 24 monthsSecondary Outcomes
Description: Serum Th2 biomarkers in patients with fungal infection and ABPA (Table 3). Serum Th1 biomarkers in patients with fungal infection and ABPA (Table 3). Serum sensitization markers to fungal allergens in patients with fungal infection and ABPA (Table 4). Baseline and historic lung function, historical comorbid diagnoses and BMI measurements in patients with fungal infection and ABPA. Environmental factors that are possibly related to fungal infection and ABPA in patients with CF. Immune profile: A profile of each group will be based upon their findings of each set of biomarkers: Th1, Th2, mold allergy panel, and systemic markers of inflammation. Based upon findings in each of these categories (elevated, depressed), we will be able to formulate a profile based upon the type of marker/inflammatory pathway.
Measure: Other markers of fungal inflammation and allergic reaction in patients with CF Time: Average of 24 monthsOther Outcomes
Description: Banking of both sputum and serum to potentially utilize microbiome and transcriptome techniques for further immunotyping and infection characterization.
Measure: Biobanking of specimens Time: Average of 24 months