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
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 pointFibrosis