- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02480270
Outpatient Antibiotic Treatment for a Cystic Fibrosis Pulmonary Exacerbation
4. mai 2018 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
32
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Colorado
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Aurora, Colorado, Forente stater, 80045
- University of Colorado Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
8 år til 18 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
30 patients with cystic fibrosis will be recruited from the University of Colorado and Children's Hospital Colorado pediatric cystic fibrosis clinic.
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Reduction in bacterial colony count in the primary cystic fibrosis (CF) pathogen identified on culture
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Lung function
Tidsramme: Baseline and 3 weeks
|
|
Baseline and 3 weeks
|
|
Airway inflammation
Tidsramme: 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
Tidsramme: Baseline and 3 weeks
|
Change in patient reported symptoms and severity (Cystic Fibrosis Questionnaire-Revised)
|
Baseline and 3 weeks
|
|
Microbiome
Tidsramme: Baseline and 3 weeks
|
Change in airway microbiota in sputum samples obtained before and after oral antibiotics
|
Baseline and 3 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Jordana E Hoppe, M.D., University of Colorado, Denver
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2014
Primær fullføring (Faktiske)
4. januar 2017
Studiet fullført (Faktiske)
4. januar 2017
Datoer for studieregistrering
Først innsendt
15. juni 2015
Først innsendt som oppfylte QC-kriteriene
19. juni 2015
Først lagt ut (Anslag)
24. juni 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. mai 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. mai 2018
Sist bekreftet
1. mai 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14-0745
- UL1TR001082 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Cystisk fibrose
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