2013
Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis
Mayer‐Hamblett N, Rosenfeld M, Treggiari MM, Konstan MW, Retsch‐Bogart G, Morgan W, Wagener J, Gibson RL, Khan U, Emerson J, Thompson V, Elkin EP, Ramsey BW, for the EPIC E. Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis. Pediatric Pulmonology 2013, 48: 943-953. PMID: 23818295, PMCID: PMC4059359, DOI: 10.1002/ppul.22693.Peer-Reviewed Original ResearchConceptsTobramycin inhalation solutionHistorical controlsCystic fibrosisTrial participantsCulture positivityPA recurrenceDifferent antibiotic regimensHistorical control cohortInitial eradication therapyIncidence of hospitalizationStandard of careAntibiotic regimensEradication therapyRespiratory symptomsStandard careHospitalization outcomesHospitalization ratesCare treatmentControl cohortInhalation solutionAntimicrobial therapyClinical trialsEpidemiologic studiesInfection controlEligibility criteria
2012
Pseudomonas aeruginosa serology and risk for re-isolation in the EPIC trial
Anstead M, Heltshe SL, Khan U, Barbieri JT, Langkamp M, Döring G, Dharia S, Gibson RL, Treggiari MM, Lymp J, Rosenfeld M, Ramsey B. Pseudomonas aeruginosa serology and risk for re-isolation in the EPIC trial. Journal Of Cystic Fibrosis 2012, 12: 147-153. PMID: 22944725, PMCID: PMC3696392, DOI: 10.1016/j.jcf.2012.08.001.Peer-Reviewed Original ResearchConceptsPulmonary exacerbationsCF patientsP. aeruginosa eradicationP. aeruginosa isolationCystic fibrosis patientsEarly P. aeruginosaBaseline seropositivityEPIC trialPositive serologyAntibiotic therapyChild TrialTreatment failurePrognostic valuePseudomonas infectionWeek 10Fibrosis patientsSerologyCulture resultsPatientsClinicians' effortsExacerbationSeropositivityP. aeruginosaRiskTrials
2011
Comparative Efficacy and Safety of 4 Randomized Regimens to Treat Early Pseudomonas aeruginosa Infection in Children With Cystic Fibrosis
Treggiari MM, Retsch-Bogart G, Mayer-Hamblett N, Khan U, Kulich M, Kronmal R, Williams J, Hiatt P, Gibson RL, Spencer T, Orenstein D, Chatfield BA, Froh DK, Burns JL, Rosenfeld M, Ramsey BW, Investigators F. Comparative Efficacy and Safety of 4 Randomized Regimens to Treat Early Pseudomonas aeruginosa Infection in Children With Cystic Fibrosis. JAMA Pediatrics 2011, 165: 847-856. PMID: 21893650, PMCID: PMC3991697, DOI: 10.1001/archpediatrics.2011.136.Peer-Reviewed Original ResearchConceptsPseudomonas aeruginosa infectionCulture-based therapyCulture-based groupsCystic fibrosisAeruginosa infectionEarly Pseudomonas aeruginosa infectionTobramycin inhalation solutionPrimary end pointRate of exacerbationsExacerbation rateIntravenous antibioticsOral ciprofloxacinOral placeboAntibiotic regimensPulmonary exacerbationsAdverse eventsTreat analysisMulticenter trialAntipseudomonal treatmentInhalation solutionOdds ratioComparative efficacyPlaceboEnd pointFibrosisInitial Pseudomonas aeruginosa treatment failure is associated with exacerbations in cystic fibrosis
Mayer‐Hamblett N, Kronmal RA, Gibson RL, Rosenfeld M, Retsch‐Bogart G, Treggiari MM, Burns JL, Khan U, Ramsey BW, Investigators F. Initial Pseudomonas aeruginosa treatment failure is associated with exacerbations in cystic fibrosis. Pediatric Pulmonology 2011, 47: 125-134. PMID: 21830317, PMCID: PMC3214247, DOI: 10.1002/ppul.21525.Peer-Reviewed Original ResearchConceptsExacerbation riskInitial eradicationCystic fibrosisPseudomonas aeruginosa acquisitionInitial antibiotic treatmentPositive respiratory culturesPA recurrenceProportional hazards modelSymptom-based definitionEPIC trialPulmonary exacerbationsAntibiotic therapyTreatment failureClinical benefitPA infectionRespiratory culturesSubsequent exacerbationAntibiotic treatmentEarly eradicationHigh riskNegative culturesExacerbationHazards modelSignificant predictorsTrials
2009
Early anti-pseudomonal acquisition in young patients with cystic fibrosis: Rationale and design of the EPIC clinical trial and observational study,
Treggiari MM, Rosenfeld M, Mayer-Hamblett N, Retsch-Bogart G, Gibson RL, Williams J, Emerson J, Kronmal RA, Ramsey BW, Group E. Early anti-pseudomonal acquisition in young patients with cystic fibrosis: Rationale and design of the EPIC clinical trial and observational study,. Contemporary Clinical Trials 2009, 30: 256-268. PMID: 19470318, PMCID: PMC2783320, DOI: 10.1016/j.cct.2009.01.003.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAnti-Bacterial AgentsChildChild, PreschoolCiprofloxacinCohort StudiesCystic FibrosisDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansInfantLongitudinal StudiesMalePseudomonas aeruginosaPseudomonas InfectionsRisk FactorsTobramycinTreatment OutcomeConceptsEarly Pa infectionYoung CF patientsRespiratory culturesRisk factorsCystic fibrosisCohort studyPA infectionClinical trialsObservational studyCF patientsEarly CF lung diseaseProgressive obstructive pulmonary diseaseProportion of patientsClinical efficacy dataObstructive pulmonary diseasePositive respiratory culturesPatients ages 1Longitudinal cohort studyCF lung diseaseChronic endobronchial infectionInfection control programPa acquisitionPA-negative patientsOral ciprofloxacinOral placebo
2007
Approach to eradication of initial Pseudomonas aeruginosa infection in children with cystic fibrosis
Treggiari MM, Rosenfeld M, Retsch‐Bogart G, Gibson R, Ramsey B. Approach to eradication of initial Pseudomonas aeruginosa infection in children with cystic fibrosis. Pediatric Pulmonology 2007, 42: 751-756. PMID: 17647287, DOI: 10.1002/ppul.20665.Peer-Reviewed Original ResearchMeSH KeywordsAnti-Infective AgentsChildClinical Trials as TopicCystic FibrosisHumansPseudomonas aeruginosaPseudomonas InfectionsTreatment OutcomeConceptsAnti-pseudomonal antibioticsCystic fibrosisEarly interventionInitial Pseudomonas aeruginosa infectionSafe treatment regimenObstructive lung diseasePseudomonas aeruginosa infectionChronic endobronchial infectionLower airwaysTreatment regimenEndobronchial infectionClinical benefitLarge trialsLung diseaseAeruginosa infectionPA isolatesYoung childrenPa acquisitionFibrosisInfectionChildrenPrimary causePseudomonas aeruginosaWindow of opportunityEradication