Trial reportAntimicrobial agents and chemotherapy2003
High-dose azithromycin versus high-dose amoxicillin-clavulanate for treatment of children with recurrent or persistent acute otitis media.
Trial report in Antimicrobial agents and chemotherapy, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 4 syntheses or guidelines pooled it, 50 citations in OpenAlex.
- Antibiotic treatment of acute and recurrent otitis media in children: an Italian intersociety Consensus.Italian journal of pediatrics · 2025Guideline
- Efficacy and safety of azithromycin and amoxicillin/clavulanate for otitis media in children: a systematic review and meta-analysis of randomized controlled trials.Annals of clinical microbiology and antimicrobials · 2021Pooled it
- Pooled it
- Short-course antibiotics for acute otitis media.The Cochrane database of systematic reviews · 2010Pooled it
- Blood, tissue, and intracellular concentrations of azithromycin during and after end of therapy.Antimicrobial agents and chemotherapy · 2013Trial
- Clinical Outcomes with High-Dose Amoxycillin-Clavulanate Suspension in Children with Respiratory Tract Infections: A Prospective, Multicentre, Phase IV Study in India.Advances in therapy · 2026Article
- Ketolides--the modern relatives of macrolides : the pharmacokinetic perspective.Clinical pharmacokinetics · 2009Review
- Optimizing therapy with antibacterial agents: use of pharmacokinetic-pharmacodynamic principles in pediatrics.Paediatric drugs · 2007Review
- Searching for the Holy Grail of acute otitis media.Archives of disease in childhood · 2006Article
- Study design questions in treatment of children with acute otitis media.Antimicrobial agents and chemotherapy · 2004Article
- Single-dose (30 mg/kg) azithromycin compared with 10-day amoxicillin/clavulanate for the treatment of uncomplicated acute otitis media: a double-blind, placebo-controlled, randomized clinical trial.Current therapeutic research, clinical and experimental · 2003Article
- Reported rates of diarrhea following oral penicillin therapy in pediatric clinical trials.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAGReview
Corrections and comments
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Authors and funding
9 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Infants and young children, especially those in day care, are at risk for recurrent or persistent acute otitis media (AOM). There are no data on oral alternatives to high-dose amoxicillin-clavulanate for treating AOM in these high-risk patients. In this double-blind, double-dummy multicenter clinical trial, we compared a novel, high-dose azithromycin regimen with high-dose amoxicillin-clavulanate for treatment of children with recurrent or persistent AOM. Three hundred four children were randomized; 300 received either high-dose azithromycin (20 mg/kg of body weight once a day for 3 days) or high-dose amoxicillin-clavulanate (90 mg/kg divided twice a day for 10 days). Tympanocentesis was performed at baseline; clinical response was assessed at day 12 to 16 and day 28 to 32. Two-thirds of patients were aged < or =2 years. A history of recurrent, persistent, or recurrent plus persistent AOM was noted in 67, 18, and 14% of patients, respectively. Pathogens were isolated from 163 of 296 intent-to-treat patients (55%). At day 12 to 16, clinical success rates for azithromycin and amoxicillin-clavulanate were comparable for all patients (86 versus 84%, respectively) and for children aged < or =2 years (85 versus 79%, respectively). At day 28 to 32, clinical success rates for azithromycin were superior to those for amoxicillin-clavulanate for all patients (72 versus 61%, respectively; P = 0.047) and for those aged < or =2 years (68 versus 51%, respectively; P = 0.017). Per-pathogen clinical efficacy against Streptococcus pneumoniae and Haemophilus influenzae was comparable between the two regimens. The rates of treatment-related adverse events for azithromycin and amoxicillin-clavulanate were 32 and 42%, respectively (P = 0.095). Corresponding compliance rates were 99 and 93%, respectively (P = 0.018). These data demonstrate the efficacy and safety of high-dose azithromycin for treating recurrent or persistent AOM.
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