Four Weeks of Antibiotics better than 2 weeks course in Kids with Chronic Wet Cough

The current standard treatment in European and American guidelines is 2 weeks of antibiotics, but the optimal duration of therapy is unknown. Therefore, Dr Tom J C Ruffles and his team conducted a first randomized controlled trial to assess the duration of antibiotic treatment in children with chronic wet cough and suspected PBB. The researchers hypothesized that 4 weeks of amoxicillin-clavulanate is superior to 2 weeks for improving clinical outcomes.

It was a multicenter, parallel, double-blind, placebo-controlled, randomized controlled trial. The researchers included a total of 106 children with chronic (>4 weeks duration) wet cough and suspected PBB. They were randomly assigned to receive 4 weeks of amoxicillin-clavulanate (25–35 mg/kg twice daily oral suspension; 4-week group n=52) or 2 weeks of amoxicillin-clavulanate followed by 2 weeks of placebo (2-week group n=54). The major outcome assessed was a clinical cure (cough resolution) by day 28. The researchers also assessed the recurrence of PBB at 6 months, time to next exacerbation, change in Parent-proxy Cough-Specific Quality-of-Life (PC-QoL) score from baseline to day 28 and from day 28 to 7 months, adverse events, nasal swab bacteriology, and antimicrobial resistance.

Key findings of the study were:

• By day 28, the researchers found that the primary endpoint of clinical cure in the 4-week group (32 [62%] of 52 patients) was not significantly different to the 2-week group (38 [70%] of 54 patients; adjusted relative risk 0·87.).
• They noted that the time to next wet cough exacerbation was significantly longer in the 4-week group than the 2-week group (median 150 days vs 36 days; adjusted hazard ratio 0·47).
• They also noted that the rate of recurrence of PBB at six months was 53% in the 4-week group and 74% in the 2-week group. However, they found no significant difference between the groups (adjusted odds ratio 0·39).
• They observed a significant improvement in the PC-QoL from baseline to day 28 in both groups, but they found no significant difference between them (mean difference in change −0·2).
• The median PC-QOL and the data on respiratory pathogens and antimicrobial resistance were similar between groups.
• They reported 13 adverse events (25%) in the 2-week group and ten (19%) in the 4-week group.

The authors concluded, "A 4-week course of amoxicillin-clavulanate for treating children with chronic wet cough and suspected PBB confers little advantage compared with a 2-week course in achieving clinical cure by 28 days. However, as a 4-week duration led to a longer cough-free period, identifying children who would benefit from a longer antibiotic course is a priority."

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DOI: https://doi.org/10.1016/S2213-2600(21)00104-1