Azithromycin does not improve disease course in hospitalized infants with respiratory syncytial virus (RSV) lower respiratory tract disease: a randomized equivalence trial. Clarithromycin in the treatment of RSV bronchiolitis: a double-blind, randomised, placebo-controlled trial. Antibiotic treatment of epidemic bronchiolitis--a double-blind trial. Management of bronchiolitis without antibiotics: a multicentre randomized control trial in Bangladesh.
Nearly half of all hospitalized infants with respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) are treated with (parenteral) antibiotics. The present study was designed to test our hypothesis that the use of antibiotics would not lead to a reduced duration of hospitalization in mild to moderate RSV LRTD.
                Seventy-one patients < or =24 months of age with a virologically confirmed clinical diagnosis of RSV LRTD were randomized to azithromycin 10 mg/kg/day (n = 32) or placebo (n = 39) in a multicenter, randomized, double-blind, placebo-controlled equivalence trial during three RSV seasons (2002-2004 through 2005-2006). Primary endpoint was duration of hospitalization, secondary endpoints included duration of oxygen supplementation and nasogastric tube feeding, course of RSV symptom score, number of PICU referrals and number of patients who received additional antibiotic treatment. Data were analyzed according to the intention-to-treat principle using the Mann-Whitney U-test or chi2 test considering P < 0.05 as statistically significant.
                Included patients were comparable with respect to baseline demographics, clinical characteristics, laboratory and roentgenologic investigations. The mean duration of hospitalization was not significantly different between patients treated with azithromycin or placebo (132.0 +/- 10.8 vs. 139.6 +/- 7.7 hr, P = 0.328). Azithromycin was not associated with a stronger resolution of clinical symptoms represented by the RSV symptom score. Four patients were treated with antibiotics after 72 hr, three of them were assigned to placebo (P = 0.406).
                Infants and young children with RSV LRTD do not benefit from routine treatment with antibiotics (ISRCTN number 86554663).
                Copyright 2007 Wiley-Liss, Inc. Respiratory syncytial virus (RSV) bronchiolitis is the most common lower respiratory tract infection in infancy. To date, there is no effective therapy for RSV bronchiolitis. In order to investigate the efficacy of clarithromycin in the treatment of RSV bronchiolitis, the present authors conducted a randomised, double-blind, placebo-controlled trial comparing clarithromycin with placebo in 21 infants with a diagnosis of RSV bronchiolitis. The infants were randomised to receive clarithromycin or placebo daily for 3 weeks. Levels of interleukin (IL)-4, IL-8, eotaxin, and interferon-gamma were determined in plasma, before and after treatment, using ELISA. Six months after treatment, parents were surveyed as to whether their child had experienced wheezing within the previous 6 months. Treatment with clarithromycin was associated with a statistically significant reduction in the length of hospital stay, the duration of need for supplemental oxygen and the need for beta(2)-agonist treatment. There were significant decreases in plasma IL-4, IL-8 and eotaxin levels after 3 weeks of treatment with clarithromycin. Readmission to the hospital within 6 months after discharge was significantly lower in the clarithromycin group. In conclusion, clarithromycin has statistically significant effects on the clinical and laboratory findings in respiratory syncytial virus bronchiolitis. Therefore, clarithromycin treatment may be helpful in reducing the short-term effects of respiratory syncytial virus bronchiolitis. nan To ascertain that antibiotics have no role in the management of bronchiolitis.
                Multicentre randomized control trial (RCT).
                Five purposively selected teaching hospitals in Bangladesh.
                Children under 24 months old with bronchiolitis.
                Children were randomized into three groups of therapeutic interventions: parenteral ampicillin (P-Ab), oral erythromycin (O-Ab) and no antibiotic (N-Ab) in adjunct to supportive measures.
                Clinical improvement was assessed using 18 symptoms/signs which were graded on a two-point recovery scale of 'rapid' and 'gradual', indicating improvement within 'four days' and 'beyond four days', respectively.
                Each intervention group consisted of 98 +/- 1 children having comparable clinico-epidemiological characteristics at the baseline. The trial revealed that most chesty features (features appearing to arise from chest, i.e. cough, breathing difficulty, wheeze, chest indrawing, tachypnoea, tachycardia, rhonchi and crepitation) demonstrated a gradual recovery, beyond 4th admission day and, not differing among the three intervention groups (p > 0.23, p < 0.62, p = 0.54, p < 0.27, p = 0.75, p = 0.76, p = 0.81, p > 0.98, respectively). Most non-chesty features (features appearing to arise away from chest, i.e. feeding/sleeping difficulties, social smile, restlessness, inconsolable crying, nasal flaring, fever and hypoxaemia) demonstrated a rapid recovery, within 4 days, remaining comparable among the three intervention groups (p < 0.07, p = 0.65, p = 0.24, p < 0.61, p = 0.22, p = 0.84, p = 0.29 and p = 0.96, respectively). However, nasal symptoms (runny nose and nasal blockage) also showed no difference among groups (p = 0.36 and p = 0.66, respectively). Thus, the dynamics of clinical outcome obviates that children not receiving antibiotics had similar clinical outcome than those who did.
                In hospital settings, managing bronchiolitis with only supportive measures but without antibiotics remains preferable.
This review found minimal evidence to support the use of antibiotics for bronchiolitis. Research to identify a possible small subgroup of patients who have complications from bronchiolitis such as respiratory failure and who may benefit from antibiotics is justified.