- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02480270
Outpatient Antibiotic Treatment for a Cystic Fibrosis Pulmonary Exacerbation
4 maj 2018 uppdaterad av: University of Colorado, Denver
Prospective Clinical and Laboratory Evaluation of Outpatient Antibiotic Treatment for Pulmonary Exacerbations in Children With Cystic Fibrosis
This study plans to learn more about the effect of oral antibiotics for an outpatient pulmonary exacerbation (respiratory illness) on sputum (mucus) bacterial infections, lung function, airway inflammation and quality of life.
In this study subjects will perform pulmonary function tests, provide a sputum sample and complete a questionnaire at two separate clinic visits.
If a subject is unable to cough up sputum in clinic he or she will be asked to breathe in a salt water solution to help cough up sputum.
The first sputum sample will be obtained at the first visit (within 48 hours of starting antibiotics).
Pulmonary function testing and the questionnaire will also be completed at this time.
Subjects will complete a two week course of oral antibiotics at home.
During these two weeks subjects will be asked to write down the times antibiotics are taken and airway clearance (vest treatment) is performed.
Within one week of completing the antibiotic course subjects will return to clinic for a second visit.
At that time a sputum sample will be obtained again and if subjects are unable to cough up sputum they will again be asked to breathe in salt water solution to help cough up sputum.
Pulmonary function testing and the questionnaire will also be completed at this second visit.
Sputum samples will be tested for infections with bacteria and viruses.
Sputum samples will also be used to measure markers of airway inflammation (swelling).
The investigators hypothesize that the use of two weeks of oral antibiotics for the treatment of a pulmonary exacerbation will result in a decrease in the amount of bacteria measured in sputum.
Additionally the investigators hypothesize that treatment with antibiotics will lead to an improvement in lung function, a decrease in airway inflammation and an improvement in quality of life measurements.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
32
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Colorado
-
Aurora, Colorado, Förenta staterna, 80045
- University of Colorado Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
8 år till 18 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
30 patients with cystic fibrosis will be recruited from the University of Colorado and Children's Hospital Colorado pediatric cystic fibrosis clinic.
Beskrivning
Inclusion Criteria:
- Diagnosis of cystic fibrosis based on sweat chloride (≥60) or two known disease causing mutations.
- Age 8 - 18 years
- Starting treatment for an outpatient pulmonary exacerbation
- Willing to participate in study after informed consent and assent has been obtained.
Exclusion Criteria:
- Forced expiratory volume in 1 second (FEV1) less than 40%
- Patients receiving chronic daily oral antibiotics. Patients receiving azithromycin therapy three times a week will not be excluded as its use in this setting is felt to be anti-inflammatory.
- Previous reaction to inhalation of hypertonic saline. This is distinctly unusual in cystic fibrosis.
- Patients who have been treated with oral antibiotics on an outpatient basis within 2 weeks of the exacerbation.
- Patients who are being started simultaneously on inhaled and oral antibiotics. Patients who are routinely receiving inhaled antibiotics as part of their chronic management and continue inhaled antibiotics as previously scheduled will not be excluded.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Reduction in bacterial colony count in the primary cystic fibrosis (CF) pathogen identified on culture
Tidsram: Baseline and 3 weeks
|
Quantitative measurements of the primary CF pathogen will be obtained on sputum culture at visits 1 and 2. The change in colony count (measured on the log scale) will be used as the primary outcome.
|
Baseline and 3 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Lung function
Tidsram: Baseline and 3 weeks
|
|
Baseline and 3 weeks
|
|
Airway inflammation
Tidsram: Baseline and 3 weeks
|
Change in measurements of sputum total white blood cell count, neutrophil count, neutrophil elastase, LTB4 (leukotriene B4), IL-8 (interleukin 8), IL-1B (interleukin 1, beta)
|
Baseline and 3 weeks
|
|
Quality of Life
Tidsram: Baseline and 3 weeks
|
Change in patient reported symptoms and severity (Cystic Fibrosis Questionnaire-Revised)
|
Baseline and 3 weeks
|
|
Microbiome
Tidsram: Baseline and 3 weeks
|
Change in airway microbiota in sputum samples obtained before and after oral antibiotics
|
Baseline and 3 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Jordana E Hoppe, M.D., University of Colorado, Denver
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2014
Primärt slutförande (Faktisk)
4 januari 2017
Avslutad studie (Faktisk)
4 januari 2017
Studieregistreringsdatum
Först inskickad
15 juni 2015
Först inskickad som uppfyllde QC-kriterierna
19 juni 2015
Första postat (Uppskatta)
24 juni 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 maj 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 maj 2018
Senast verifierad
1 maj 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 14-0745
- UL1TR001082 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .