Setting: 104 study sites in 24 countries.
Patients: Patients (six-14 years of age) with mild persistent asthma as defined by the Global Initiative for Asthma (GINA) guidelines and otherwise in good health. Patients were required to have a FEV1 of ≥80% while the beta-receptor agonist was withheld for more than six hours in the first two visits and ≥70% on the third visit of the run-in period.
Intervention: Patients were randomized to receive either montelukast (5 mg oral before bedtime or 10 mg for patients ≥15) or fluticasone (100 mcg through MDI twice a day) and the appropriate placeboes.
Main outcome measures: Percentage of asthma rescue-free days (RFD).
RFD was defined as a day without:
- The use of a rescue medication: defined as any day during which a beta-receptor agonist, a systemic corticosteroid, or other rescue medications were used; and
- The use of an asthma health resource: defined as an unscheduled visit to a physician, an urgent/emergency care center or a hospital.
Main results: The number of RFDs were statistically similar between both groups. Mean percentage of RFD was 84% in the montelukast group and 86.7% in the fluticasone group.
Conflict of interest: Two of the study authors were employees of Merck and Company, which markets montelukast.
Commentary: This is an extensive study with multiple outcome measures. The study mimics actual clinical experience by using clinically relevant end points as primary outcomes. The study does not have a placebo control group. Overall the study showed that there is no significant difference between montelukast and fluticasone with regard to the primary outcome of RFDs, but there were some differences favoring fluticasone in secondary outcome measures, including number of days of beta-receptor agonist use and improvement of the average score of the control domain of the Pediatric Asthma Therapy Assessment Questionnaire.
K. Kingae Causes Osteomyelitis/Septic Arthritis
Kiang KM, Ogunmodede F, Juni BA, et al. Outbreak of osteomyelitis/septic arthritis caused by Kingella kingae among child care center attendees. Pediatrics. 2005;116;e206-213.
Review by Julia Simmons, MD
Kingella kingae (K. kingae), a gram-negative organism known to colonize the oropharynx, may cause invasive diseases, such as septic arthritis and osteomyelitis in children who were previously healthy. In this article, the authors describe the first reported outbreak of K. kingae causing osteomyelitis/septic arthritis.
In October 2003 the Minnesota Department of Health was notified of an outbreak of K. kingae at a daycare facility. There were two culture positive cases and one culture negative but clinically presumed to be secondary to K. kingae. The children were all in the same classroom (toddler classroom 1) and were between the ages of 17 and 21 months. The previously healthy children presented with fever and limp.
In this cohort study, the authors investigated risk factors for invasive disease and for colonization with K. kingae. They also determined the prevalence of asymptomatic colonization at the daycare involving the confirmed cases and at a second daycare facility, which served as the control. Culture samples were analyzed at the Minnesota Department of Health Public Health Laboratory. The laboratory performed confirmation, pulsed-field gel electrophoresis, DNA sequencing, and antimicrobial testing specifically with rifampin, penicillin, and azithromycin.
At the study facility 115/122 (94%) children and 28/29 (97%) adult staff members were cultured. Fifteen (13 %) of the children were colonized. The prevalence of colonization was 45% (9 children) in the toddler 1 classroom, which is the classroom of the confirmed cases. The three case patients had negative oropharyngeal cultures; however, all three had been pretreated with antibiotic therapy. The pulsed-field gel electrophoresis was indistinguishable in the confirmed cases and the colonized students. The authors did not discover any risk factors for invasive disease. This information was gathered from a list of questions regarding past medical history, which the parents discussed on the telephone with the investigators. Rifampin, penicillin, and azithromycin all had low MICs