An uncontrolled open-label, multicenter study to monitor the antiviral activity and safety of inhaled zanamivir (as Rotadisk via Diskhaler device) among Chinese adolescents and adults with influenza-like illness.

BACKGROUND: It is the first multicenter clinical study in China to investigate zanamivir use among Chinese adolescents and adults with influenza-like illness (ILI) since 2009, when inhaled zanamivir (RELENZA(®)) was marketed in China. METHODS: An uncontrolled open-label, multicentre study to evaluate the antiviral activity, and safety of inhaled zanamivir (as Rotadisk via Diskhaler device); 10 mg administered twice daily for 5 days in subjects ≥ 12 years old with ILI. Patients were enrolled within 48 hours of onset and followed for eight days. Patients were defined as being influenza-positive if the real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) test had positive results. RESULTS: A total of 400 patients ≥ 12 years old were screened from 11 centers in seven provinces from March 2010 to January 2011. Three hundred and ninety-two patients who took at least one dose of zanamivir were entered into the safety analysis. The mean age was 33.8 years and 50% were male. Cardiovascular diseases and diabetes were the most common comorbidities. All the reported adverse events, such as rash, nasal ache, muscle ache, nausea, diarrhea, headache, occurred in less than 1% of subjects. Mild sinus bradycadia or arrhythmia occurred in four subjects (1%). Most of the adverse events were mild and did not require any change of treatment. No severe adverse events (SAE) or fatal cases were reported. Bronchospasm was found in a 38 years old woman whose symptoms disappeared after stopping zanamivir and without additional treatment. All the 61 influenza virus isolates (43 before enrollment, 18 during treatment) proved to be sensitive to zanamivir. CONCLUSIONS: Zanamivir is well tolerated by Chinese adolescents and adults with ILIs. There is no evidence for the emergence of drug-resistant isolates during treatment with zanamivir.

Evaluation of the Japanese Respiratory Society guidelines for the identification of Mycoplasma pneumoniae pneumonia.

BACKGROUND AND OBJECTIVE: Community-acquired pneumonia (CAP) is a leading cause of morbidity and mortality worldwide. Mycoplasma pneumoniae is one of the major causative pathogens of CAP. Early diagnosis of M. pneumoniae pneumonia is crucial for initiating appropriate antibiotic therapy. The aim of this study was to determine whether the Japanese Respiratory Society (JRS) guidelines on CAP are effective for diagnosing M. pneumoniae pneumonia. METHODS: Between August 2008 and July 2009, adult outpatients with CAP were consecutively enrolled. The aetiology of CAP was determined by culture and real-time polymerase chain reaction (PCR) methods to detect M. pneumoniae, urine antigen tests to detect Streptococcus pneumoniae and Legionella pneumoniae, blood and sputum culture for bacteria and real-time PCR for eight common respiratory viruses. The predictive value of the JRS guidelines for differentiating M. pneumoniae pneumonia from typical bacterial and viral pneumonias was determined. RESULTS: Data from 215 adult CAP outpatients was analyzed. An aetiological diagnosis was made for 105 patients (48.8%), including 62 patients with M. pneumoniae pneumonia, 17 patients with typical bacterial pneumonia and 23 patients with viral pneumonia. According to the JRS criteria for differential diagnosis of atypical pneumonia, 55 of 62 patients were correctly diagnosed with M. pneumoniae pneumonia (sensitivity 88.7%), and 31 of 40 patients with bacterial and viral pneumonia were correctly excluded (specificity 77.5%). CONCLUSIONS: The JRS guidelines on CAP provide a useful tool for the identification of M. pneumoniae pneumonia cases and differentiating these from cases of typical bacterial or viral pneumonia.

Evaluation of a new real-time PCR assay for detection of Mycoplasma pneumoniae in clinical specimens.

OBJECTIVE: To establish and evaluate a real-time PCR assay to detect Mycoplasma pneumoniae (M.pneumoniae) in clinical specimens. METHODS: By analysing the whole p1 gene sequence of 60 M.pneumoniae clinical isolates in Beijing of China, an optimized real-time PCR assay (MpP1) using p1 gene conserved region was designed. The specificity and sensitivity of this assay were evaluated and compared with other two reported assays (RepMp1 and Mp181) using 40 positive and 100 negative clinical specimens. RESULTS: The detection limit of the new assay was 8.1 fg (about 1∼3CFU) M.pneumoniae DNA. The sensitivity of MpP1, RepMp1, and Mp181 assays appeared to be 100%, 100%, and 85%, respectively. CONCLUSION: MpP1 assay is suitable for the detection of M.pneumoniae in Chinese clinical specimens.

Clinical features of pneumonia caused by 2009 influenza A(H1N1) virus in Beijing, China.

BACKGROUND: Data on symptoms and radiographic changes in patients with pandemic 2009 influenza A(H1N1) (A[H1N1]) pneumonia during convalescence have not been reported. METHODS: During October 26, 2009, and January 23, 2010, adult patients with pneumonia with laboratory-confirmed or clinically suspected A(H1N1) infections were observed for clinical characteristics, high-resolution chest CT scan, and lung function test changes during acute and 3-month convalescent phases. RESULTS: Of the 65 case subjects, the median age was 41 (interquartile range [IQR], 28-57) years, 60.0% were men, and 55.4% had at least one underlying medical condition. Sixty-two patients started oseltamivir therapy within a median of 5 (IQR, 4-6) days from the onset of illness, and 31 received IV corticosteroids. ARDS developed in 33 patients, and 24 were treated initially with noninvasive positive pressure ventilation (NPPV). In this group, NPPV was successful in 13 patients (54.2%). Nine patients died at a median of 16 (IQR, 10-24) days after onset of illness. Multivariate Cox regression identified two independent risk factors for death: progressive dyspnea after resolution of fever (relative risk, 5.852; 95% CI, 1.395-24.541; P = .016) and a higher APACHE (Acute Physiology and Chronic Health Evaluation) II score on presentation (relative risk for each point, 1.312; 95% CI, 1.140-1.511; P < .001). At 3-month follow-up of survivors with A(H1N1), ground-glass opacities were still present, although diminished, in 85.7%, and diffusing capacity for carbon monoxide was mildly reduced in 61.5%. CONCLUSIONS: Ground-glass opacities and decreased diffusing capacity were the main abnormalities observed at 3-month follow-up of survivors of A(H1N1).

High prevalence of macrolide resistance in Mycoplasma pneumoniae isolates from adult and adolescent patients with respiratory tract infection in China.

The resistance rate of 67 Mycoplasma pneumoniae isolates from 356 ambulatory adult patients with respiratory tract infection was 69% (46 of 67). All 46 macrolide-resistant strains harbored point mutations in the 23S ribosomal RNA gene. Patients infected with macrolide-resistant M. pneumoniae required significantly longer durations of antibiotic therapy and had longer time to resolution of fever.