Abstract
Methods: We conducted a multicentre, parallel group, double‐dummy, double‐blind placebo‐controlled RCT trial in 4 centres. At the start of an exacerbation, 179 children were randomised to receive either amoxycillin‐clavulanate (22.5 mg/kg bd)/placebo or azithromycin (5mg/kg/day)/placebo for 21‐days. Our primary outcome was resolution of exacerbation (defined as ‘return to baseline') by 21‐days. Study was powered for 90% (α=0.05, 1‐sided) with 20% non‐inferiority margin to detect 80% resolution rate by day‐21. Secondary outcomes were cough‐specific quality of life (PC‐QoL) and duration of exacerbation. Generalised linear model was used to calculate relative differences between groups.
Results: Baseline characteristics of the 2 groups (amoxycillin‐clavulanate n=97 and azithromycin n=82) were similar. By day‐21, resolution was comparable between groups, relative risk 0.99 95%CI 0.84‐1.17, falling within the a‐priori calculated 20% non‐inferiority margin. Between group differences for duration of exacerbation (2 days 95%CI ‐1.7, 5.3) and PC‐QoL at day‐21 compared to beginning of exacerbation was also within our non‐inferiority margin (0.42, 95%CI ‐0.06, 0.89).
Conclusion: Azithromycin is non‐inferior to amoxicillin‐clavulanate for treating non‐severe exacerbations of bronchiectasis in children. Azithromycin may be preferred to amoxicillin‐clavulanate in selected settings e.g. adherence. However, its use needs to be balanced with risk of treatment failure (within 20% compared to amoxicillin‐clavulanate) and inducing macrolide resistance.
| Original language | English |
|---|---|
| Article number | TO-066 |
| Pages (from-to) | 54-54 |
| Number of pages | 1 |
| Journal | Respirology |
| Volume | 23 |
| Issue number | S1 |
| DOIs | |
| Publication status | Published - 14 Mar 2018 |
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Amoxycillin-Clavulanate Vs Azithromycin for Respiratory Exacerbations of Bronchiectasis in Children : A Multi-Centre Double Blind Non-Inferiority Rct. / Goyal, V.; Grimwood, K.; Masters, I.; Brynes, C.; Marchant, J.; Morris, P.; Ware, R.; Van Aspern, P.; O'Grady, K.; Torzillo, P.; McCallum, G.; Champion, A.; Buntain, H.; Mackay, I.; Sloots, T.; Ungerer, J.; Binks, M.; Chang, A.
In: Respirology, Vol. 23, No. S1, TO-066, 14.03.2018, p. 54-54.Research output: Contribution to journal › Meeting Abstract › Research
TY - JOUR
T1 - Amoxycillin-Clavulanate Vs Azithromycin for Respiratory Exacerbations of Bronchiectasis in Children
T2 - A Multi-Centre Double Blind Non-Inferiority Rct
AU - Goyal, V.
AU - Grimwood, K.
AU - Masters, I.
AU - Brynes, C.
AU - Marchant, J.
AU - Morris, P.
AU - Ware, R.
AU - Van Aspern, P.
AU - O'Grady, K.
AU - Torzillo, P.
AU - McCallum, G.
AU - Champion, A.
AU - Buntain, H.
AU - Mackay, I.
AU - Sloots, T.
AU - Ungerer, J.
AU - Binks, M.
AU - Chang, A.
PY - 2018/3/14
Y1 - 2018/3/14
N2 - Introduction: Based on limited available data, amoxycillin‐clavulanate is the current recommended first‐line empirical oral‐antibiotic treatment for non‐severe bronchiectasis exacerbations in children. Azithromycin is an attractive alternative because of its long half‐life, reduced dosing schedule, and good safety profile in children. We tested our primary hypothesis that oral azithromycin is non‐inferior (within 20% margin) to amoxycillin‐clavulanate at achieving resolution of exacerbation by day‐21 of treatment in children with bronchiectasis.Methods: We conducted a multicentre, parallel group, double‐dummy, double‐blind placebo‐controlled RCT trial in 4 centres. At the start of an exacerbation, 179 children were randomised to receive either amoxycillin‐clavulanate (22.5 mg/kg bd)/placebo or azithromycin (5mg/kg/day)/placebo for 21‐days. Our primary outcome was resolution of exacerbation (defined as ‘return to baseline') by 21‐days. Study was powered for 90% (α=0.05, 1‐sided) with 20% non‐inferiority margin to detect 80% resolution rate by day‐21. Secondary outcomes were cough‐specific quality of life (PC‐QoL) and duration of exacerbation. Generalised linear model was used to calculate relative differences between groups.Results: Baseline characteristics of the 2 groups (amoxycillin‐clavulanate n=97 and azithromycin n=82) were similar. By day‐21, resolution was comparable between groups, relative risk 0.99 95%CI 0.84‐1.17, falling within the a‐priori calculated 20% non‐inferiority margin. Between group differences for duration of exacerbation (2 days 95%CI ‐1.7, 5.3) and PC‐QoL at day‐21 compared to beginning of exacerbation was also within our non‐inferiority margin (0.42, 95%CI ‐0.06, 0.89).Conclusion: Azithromycin is non‐inferior to amoxicillin‐clavulanate for treating non‐severe exacerbations of bronchiectasis in children. Azithromycin may be preferred to amoxicillin‐clavulanate in selected settings e.g. adherence. However, its use needs to be balanced with risk of treatment failure (within 20% compared to amoxicillin‐clavulanate) and inducing macrolide resistance.
AB - Introduction: Based on limited available data, amoxycillin‐clavulanate is the current recommended first‐line empirical oral‐antibiotic treatment for non‐severe bronchiectasis exacerbations in children. Azithromycin is an attractive alternative because of its long half‐life, reduced dosing schedule, and good safety profile in children. We tested our primary hypothesis that oral azithromycin is non‐inferior (within 20% margin) to amoxycillin‐clavulanate at achieving resolution of exacerbation by day‐21 of treatment in children with bronchiectasis.Methods: We conducted a multicentre, parallel group, double‐dummy, double‐blind placebo‐controlled RCT trial in 4 centres. At the start of an exacerbation, 179 children were randomised to receive either amoxycillin‐clavulanate (22.5 mg/kg bd)/placebo or azithromycin (5mg/kg/day)/placebo for 21‐days. Our primary outcome was resolution of exacerbation (defined as ‘return to baseline') by 21‐days. Study was powered for 90% (α=0.05, 1‐sided) with 20% non‐inferiority margin to detect 80% resolution rate by day‐21. Secondary outcomes were cough‐specific quality of life (PC‐QoL) and duration of exacerbation. Generalised linear model was used to calculate relative differences between groups.Results: Baseline characteristics of the 2 groups (amoxycillin‐clavulanate n=97 and azithromycin n=82) were similar. By day‐21, resolution was comparable between groups, relative risk 0.99 95%CI 0.84‐1.17, falling within the a‐priori calculated 20% non‐inferiority margin. Between group differences for duration of exacerbation (2 days 95%CI ‐1.7, 5.3) and PC‐QoL at day‐21 compared to beginning of exacerbation was also within our non‐inferiority margin (0.42, 95%CI ‐0.06, 0.89).Conclusion: Azithromycin is non‐inferior to amoxicillin‐clavulanate for treating non‐severe exacerbations of bronchiectasis in children. Azithromycin may be preferred to amoxicillin‐clavulanate in selected settings e.g. adherence. However, its use needs to be balanced with risk of treatment failure (within 20% compared to amoxicillin‐clavulanate) and inducing macrolide resistance.
KW - Respiratory System
U2 - 10.1111/resp.13267
DO - 10.1111/resp.13267
M3 - Meeting Abstract
VL - 23
SP - 54
EP - 54
JO - Respirology
JF - Respirology
SN - 1323-7799
IS - S1
M1 - TO-066
ER -