In patients at high risk of developing an opportunistic infection prior to the institution of a HAART regimen, prophylaxis should not be discontinued during the first 2 months of treatment, and maintenance therapy should be carried on despite a significant increase in the CD4 cell count.
The objective of this study was to assess the efficacy and safety of moxifloxacin versus amoxicillin-clavulanate plus roxithromycin (comparator) in adult community-acquired pneumonia (CAP) patients with risk factors. In this comparative, randomized, multicenter, open-label study, patients hospitalized for CAP received a 10-day oral treatment with either moxifloxacin (400 mg o.d.) or amoxicillin-clavulanate (1,000/125 mg t.i.d.) plus roxithromycin (150 mg b.i.d.). Clinical and bacteriological outcomes were assessed during test of cure and follow-up visits (5-7 days and 21-28 days after the end of treatment, respectively). Of 349 randomized patients, 346 were included in the intent-to-treat analysis and 289 in the per-protocol analysis. Their baseline characteristics were comparable. The most frequent risk factors for mortality were age >65 years (50.0%), alcoholism (23.1%), and comorbidities (50.6%); chronic obstructive pulmonary disease (COPD) (25.4%) and diabetes mellitus (13.6%) were the most common associated comorbidities. A causative pathogen was documented in 66 of 346 (19.1%) of the patients (including 21 with positive blood cultures). Respective per-protocol clinical success rates at test-of-cure (primary efficacy endpoint) for moxifloxacin and comparator were 131 of 151 (86.8%) and 120 of 138 (87.0%), with a 95% confidence interval (CI) of -8.0-7.6 for the difference. Bacteriological success rates (eradication) were 23 of 30 (76.7%) and 23 of 31 (74.2%); rates for patients with positive blood cultures were 10 of 14 and 4 of 6. Persistent clinical success rates at follow-up were 118 of 120 (98.3%) and 102 of 106 (96.2%), with a 95%CI of -2.2-6.4 for the difference. The intent-to-treat analysis confirmed these results. Adverse events associated with moxifloxacin and the comparator drug were reported for 42 of 171 (24.6%) and 50 of 175 (28.6%) of the patients, respectively, and comprised predominantly digestive disorders, which occurred in 9.4% and 21.1%. On the basis of these results, once-daily oral moxifloxacin alone is as effective as amoxicillin-clavulanate plus roxithromycin for the treatment of CAP in patients with risk factors.
Fifteen tularaemia cases were identified after a holiday spent at a converted mill in the Vendee region in France, between 9 and 12 August 2004. The mill was visited, and descriptive, retrospective cohort and environmental investigations were conducted. The 39 people who had stayed at the mill between 24 July and 11 August were asked about symptoms, exposure to food and animals, and leisure activities. A case was defined as a person with evidence of fever and a positive serology (seroconversion or significant rise in antibody titre, or a single titre) = 40. Culture for Francisella tularensis and polymerase chain reaction (PCR) diagnosis was carried out for drinking water, firewood, and domestic animals at the mill. Fifteen cases of tularaemia (38%) were confirmed. Twelve of the cases (80%) had the pulmonary form. None of the patients was admitted to hospital. There was a strong association between infection and participation in a dinner at the mill on 4 August (p<10-8). One of the three dogs present in the dining room was serologically positive for F. tularensis. Results of analysis of environmental samples were negative. These investigations confirmed the occurrence of a cluster of 15 tularaemia cases, in patients who were infected on the evening of 4 August, in a mill in Vend¨¦e, an endemic area for tularaemia. The investigations highlight the existence of nonspecific and benign pulmonary forms of the illness in France. The pulmonary form of infection in the human cases and the positive serology of the dog suggest contamination by inhalation of contaminated particles from the dog¡¯s fur disseminated by the dog shaking itself.
Intravenous ZDV remains an effective tool to reduce transmission in cases of virological failure, even in cART-treated women. However, for the vast majority of women with low viral loads at delivery, in the absence of obstetrical risk factors, systematic intravenous ZDV appears to be unnecessary.
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