Impact of acute antibiotic therapy on the pulmonary exacerbation endpoint in cystic fibrosis clinical trials

Mayer-Hamblett, Nicole; Saiman, Lisa; Lands, Larry C.; Anstead, Michael; Rosenfeld, Margaret; Kloster, Margaret; Fisher, Leigh; Ratjen, Félix

doi:10.1016/j.cct.2013.06.004

Cited by 8 publications

(6 citation statements)

References 32 publications

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“…For instance, rhDNase, chronic cycled inhaled antibiotics, and azithromycin therapy have known effects on inflammatory markers (36)(37)(38). Similarly, oral and intravenous antibiotics are often prescribed, and these may affect biomarker measurements and treatment effects in CF clinical trials (39). If these antioxidants are in fact working through an antiinflammatory mechanism, it does call into question the value of biomarkers of inflammation and oxidative stress measured in this study.…”

Section: Discussionmentioning

confidence: 97%

Effects of an Antioxidant-enriched Multivitamin in Cystic Fibrosis. A Randomized, Controlled, Multicenter Clinical Trial

Sagel

Khan

Jain

et al. 2018

Am J Respir Crit Care Med

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Section: Discussionmentioning

confidence: 97%

Effects of an Antioxidant-enriched Multivitamin in Cystic Fibrosis. A Randomized, Controlled, Multicenter Clinical Trial

Sagel

Khan

Jain

et al. 2018

Am J Respir Crit Care Med

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“…Secondary outcomes included incident oral antibiotic use for respiratory complaints, used as a proxy for respiratory deterioration, 17 all-cause hospitalizations, and occurrence of respiratory (rhinorrhea and nasal congestion, cough, upper respiratory tract infection, bronchospasm, pharyngitis) and/or systemic adverse events (fever, malaise, headache, vomiting, abdominal pain) for the 56 days after LAIV administration. 18,19 These symptoms are part of the standard assessment of serious adverse events of the Public Health Agency of Canada.…”

Section: Discussionmentioning

confidence: 99%

Safety of Live-Attenuated Influenza Vaccination in Cystic Fibrosis

et al. 2014

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OBJECTIVES: Given the improved efficacy of the nasal live-attenuated influenza virus vaccine (LAIV) compared with the injectable vaccine in children, we aimed to determine its safety in individuals with cystic fibrosis (CF). METHODS: A cohort of 168 study participants, aged 2 to 18 years with CF, vaccinated with LAIV between October 1, 2012, and January 30, 2013, was followed prospectively for 56 days after initial vaccination in 3 pediatric CF clinics across the province of Quebec. Days 0 to 28 post-LAIV were considered the at-risk period for all outcomes of interest, and days 29 to 56 post-LAIV were considered the non–at-risk period. Incident respiratory deteriorations were defined as an unscheduled medical visit, hospitalization, or a new course of oral antibiotics for respiratory complaints. Using a self-controlled design, incidence rate ratios (IRR) were used to compare at-risk and non–at-risk periods. RESULTS: Comparing at-risk to non–at-risk periods, there was no significant increase in the rate of incident respiratory deteriorations (IRR, 0.72; 95% confidence interval, 0.11–4.27) or all-cause hospitalizations (IRR, 1.16; 95% confidence interval, 0.30–4.81). A greater proportion of participants reported experiencing at least 1 minor respiratory and/or systemic adverse event after immunization during the at-risk period compared with the non–at-risk period (77% vs 54%, respectively). During the first week after LAIV, 13 of 168 (8%) children reported some wheezing, with the vast majority, 9 of 13 (69%), on the day of vaccination. CONCLUSIONS: There was no increased risk of respiratory deterioration or all-cause hospitalization associated with LAIV in our study population. LAIV seems well tolerated in children and adolescents with CF.

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“…However, our analysis does not address the many episodes treated with oral and/or inhaled antibiotics . These treatments may affect time to PEx and baseline FEV 1 , but the data is not well‐tracked in the CFFPR. We chose Medicaid insurance as a marker of low socioeconomic status because it has been used previously in epidemiologic studies of CF .…”

Section: Discussionmentioning

confidence: 99%

Poor recovery from cystic fibrosis pulmonary exacerbations is associated with poor long‐term outcomes

Sanders

Zhao

et al. 2017

Pediatric Pulmonology

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Rationale People with CF treated with IV antibiotics for a pulmonary exacerbation (PEx) frequently fail to recover to baseline FEV1. The long-term impact of these events has not been studied. Objectives To determine if a patient’s spirometric recovery after a PEx is associated with time to next PEx within 1 year, the spirometric recovery after the next PEx, and/or the number of PEx episodes in the next 3 years. Methods We used data from the CF Foundation Patient Registry from 2004–2011. We randomly selected one PEx per patient that met inclusion/exclusion criteria. Patients were defined as Non-Responders if their best FEV1 (in liters) recorded in the 3 months after the PEx was <90% of the best FEV1 (in liters) in the 6 months before the PEx. We compared Responders and Non-Responders using multivariable regression models. Results We randomly chose 13,954 PEx episodes that met inclusion/exclusion criteria. 2,762 (19.8%) patients were classified as Non-Responders. Non-Responders had a shorter median time to the next PEx, 235 (95% CI 218, 252) days, versus >365 days for Responders. Thirty-four percent of Non-Responders at the initial PEx were also Non-Reponders at the next PEx, versus 20% of Responders at the initial PEx. Non-Responders had more PEx episodes over the next 3 years, 4.99 (95% CI 4.84, 5.13), than Responders, 3.46 (95% CI 3.41, 3.51). Conclusions Poor recovery after a PEx is associated with a shorter time to the next PEx, increased risk of poor recovery at a second PEx, and more frequent subsequent PEx treatments.

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Impact of acute antibiotic therapy on the pulmonary exacerbation endpoint in cystic fibrosis clinical trials

Cited by 8 publications

References 32 publications

Effects of an Antioxidant-enriched Multivitamin in Cystic Fibrosis. A Randomized, Controlled, Multicenter Clinical Trial

Effects of an Antioxidant-enriched Multivitamin in Cystic Fibrosis. A Randomized, Controlled, Multicenter Clinical Trial

Safety of Live-Attenuated Influenza Vaccination in Cystic Fibrosis

Poor recovery from cystic fibrosis pulmonary exacerbations is associated with poor long‐term outcomes

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