A comparative study of azithromycin and amoxycillin in paediatric patients with acute otitis media

Mobs, E.; Rodriguez-Solares, A; Rivas, Enrique; Hoshy, Z. El

doi:10.1093/jac/31.suppl_e.73

Cited by 26 publications

(8 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…48,53,54,57,60,69,70,73 Cointervention was permitted in 38% of trials, usually with analgesics and decongestants. [46][47][48]50,51,53,57,59,[64][65][66] In 2 trials, myringotomy had been conducted in early treatment failures. 48,59 Concurrent use of a second antibiotic was seen in 1 trial.…”

Section: Methodologic Qualitymentioning

confidence: 99%

“…The 32 trials were distributed in antibiotic groups as follows: 17 were short-acting antibiotics, 26,46-58 4 were ceftriaxone sodium, 59-62 and 11 were azithromycin. [63][64][65][66][67][68][69][70][71][72][73] Two of the trials were in a language other than English.…”

Section: Literature Search and Trial Inclusionmentioning

confidence: 99%

“…65,68,70,72 Acute otitis media was diagnosed by the presence of signs and symptoms. Tympanometry 63,[68][69][70]72,73 and tympanocentesis [63][64][65]67,68,70,72,73 were frequently carried out. The mean age of each treatment arm was approximately 4 years and children were predominantly male (56%).…”

Section: Description Of Trialsmentioning

confidence: 99%

See 2 more Smart Citations

Treatment of Acute Otitis Media With a Shortened Course of Antibiotics

Kozyrskyj,

Hildes-Ripstein,

Longstaffe

et al. 1998

JAMA

139

View full text Add to dashboard Cite

Section: Methodologic Qualitymentioning

confidence: 99%

Section: Literature Search and Trial Inclusionmentioning

confidence: 99%

See 1 more Smart Citation

Treatment of Acute Otitis Media With a Shortened Course of Antibiotics

Kozyrskyj,

Hildes-Ripstein,

Longstaffe

et al. 1998

JAMA

139

View full text Add to dashboard Cite

“…[17][18][19] The same total dose of azithromycin may also be given over 3 days to treat AOM, and several studies have demonstrated clinical equivalence between once-daily azithromycin (10 mg/kg daily) for 3 days and 10-day multidose regimens of amoxicillin, amoxicillin/clavulanate, clarithromycin, and cefaclor. [20][21][22][23][24][25][26][27] Pukander and Rautianen 28 measured total middleear fluid concentrations of azithromycin in children with AOM who received a 10-mg/kg dose on day 1 followed by a 5-mg/kg dose on day 2. Total mean azithromycin concentrations at 24 and 48 hours after the initial dose were 8.61 and 9.43 µg/mL, respectively.…”

Section: A17mentioning

confidence: 99%

A pilot study of single-dose azithromycin versus three-day azithromycin or single-dose ceftriaxone for uncomplicated acute otitis media in children

Arguedas¹,

Loaiza²,

Pérez³

et al. 2003

Current Therapeutic Research

View full text Add to dashboard Cite

Background: The pharmacokinetic profile of azithromycin supports its use as single-dose therapy for uncomplicated acute otitis media (AOM) in children.Objective: This study was designed to (1) compare the safety of single-dose oral azithromycin, 3 daily doses of oral azithromycin, and a single dose of intramuscular ceftriaxone for the treatment of uncomplicated AOM in children, and (2) provide preliminary efficacy data to support initiation of a larger, comparative trial of single-dose azithromycin for the treatment of uncomplicated acute otitis media in children.Methods: In this single-center pilot study, children with uncomplicated AOM were randomly assigned to receive single-dose oral azithromycin (30 mg/kg), 3-day oral azithromycin (10 mg/kg once daily), or single-dose intramuscular ceftriaxone (50 mg/kg). Tympanocentesis was performed before administration of the first dose, and clinical response was assessed on days 14-15 and 28-30.Results: Between September 1995 and May 1997, 198 children (mean age, 2.5 years) were enrolled. All of the patients were evaluable for the safety and clinical intent-to-treat (ITT) analyses, and 98 were evaluable for the microbiologic ITT analysis. On day 14-15, rates of clinical success (cure or improvement) for the 3 treatment groups were: 62/64 (97%) for single-dose azithromycin, 60/63 (95%) for 3-day azithromycin, and 61/62 (98%) for single-dose ceftriaxone. On day 28-30, the corresponding clinical success rates were 61/65 (94%), 61/66 (92%), and 62/64 (97%). For the 98 microbiologically evaluable patients, clinical success rates at day 14-15 were 28/30 (93%) for single-dose azithromycin, 31/35 (89%) for 3-day azithromycin, and 33/33 (100%) for single-dose ceftriaxone. On day 28-30, the corresponding clinical success rates were 27/30 (90%), 30/35 (86%), Presented in part at the 4th International Conference on the Macrolides, Azalides, Streptogramins, and Ketolides (ICMASK), Barcelona, Spain, January 21-23, 1998.Accepted for publication July 1, 2003July 1, . doi:10.1016July 1, /j.curtheres.2003.005 Reproduction in whole or part is not permitted.0011-393X/03/$19.00 A16Copyright ą 2003 Excerpta Medica, Inc. A. Arguedas et al.and 32/33 (97%). Treatment-related adverse event rates for single-dose azithromycin, 3-day azithromycin, and single-dose ceftriaxone were 10.6%, 9.1%, and 9.1%, respectively. Conclusion: In this pilot study comparing single-dose azithromycin, 3-day azithromycin, and single-dose ceftriaxone for the treatment of uncomplicated AOM in children, no differences were detected among the 3 regimens. (Curr Ther Res Clin Exp. 2003;64[Suppl A]:A16-A29)

show abstract

“…Azithromycin has been used in pediatric patients for a variety of infections and found to have a lower side effect profile, low rate of discontinuation of therapy caused by side effects, and a low potential for interaction, as well as clinical efficacy similar to that of oral agents such as amoxicillin-clavulanate (1,15,16,22,24) and amoxicillin (17). However, the definition of satisfactory clinical response varied from study to study.…”

Section: Discussionmentioning

confidence: 99%

Experimental Acute Otitis Media Due to NontypeableHaemophilus influenzae: Comparison of High and Low Azithromycin Doses with Placebo

Babl

Pelton

Zhong

2002

Antimicrob Agents Chemother

View full text Add to dashboard Cite

Treatment of acute otitis media (AOM) with azithromycin results in apparent clinical success, but tympanocentesis performed 4 to 6 days after initiation of therapy in children with nontypeable Haemophilus influenzae (NTHI) recovered from initial middle ear cultures demonstrates persistence of infection in more than 50% of episodes. We sought to determine the effect of azithromycin at different doses on the density of middle ear infection due to NTHI to provide additional understanding of this dichotomy between clinical and microbiologic outcome measures in AOM. In a chinchilla model of experimental otitis media (EOM), animals treated with placebo were compared to animals receiving a single daily dose 30 or 120 mg of azithromycin per kg of body weight per day for 5 days. Microbiologic outcome was assessed by obtaining quantitative cultures from the middle ear during a 5-day course and for 1 week following therapy. Azithromycin concentrations were measured to ascertain whether a concentration-dependent effect was present. Azithromycin at 30 and 120 mg/kg/day demonstrated a dose-dependent effect on the quantitative assessment of middle ear infection due to NTHI. A 30-mg/kg dose of azithromycin daily resulted in levels in serum and areas under the serum concentration-time curve at 24 h comparable to published data obtained with children given azithromycin at 5 to 10 mg/kg in multiday regimens. Increased doses of azithromycin (120 mg/kg) achieved 2.5-to 4-fold-higher levels in serum and 3-to 6-fold-higher total levels and levels in extracellular middle ear fluid as well as more rapid reduction in bacterial density and a greater proportion of middle ears with complete sterilization than either placebo or the 30-mg/kg/day regimen.Nontypeable Haemophilus influenzae (NTHI) is one of the two most common bacterial causes of acute otitis media (AOM) in children (2, 18). Previously, investigators have demonstrated that eradication of bacterial pathogens from middle ear fluid (MEF) correlates with clinical outcome (4,7,8). Studies of azithromycin have demonstrated good outcomes in children with AOM using clinical endpoints despite the persistence of NTHI in the middle ear observed in "double-tap" (tympanocentesis) protocols. (1,15,16,22,24). Azithromycin demonstrates high intracellular and tissue concentrations and slow elimination from infected tissue but lower concentrations in extracellular MEF and serum (11, 23). The low extracellular concentration in the middle ear potentially explains the persistence of culture-positive disease in azithromycin-treated AOM due to NTHI at day 4 to 6 in children (6) and through day 7 in chinchillas as reported by Chan et al. (5).Data obtained with the chinchilla model of experimental otitis media (EOM) have consistently been found to correlate with subsequent clinical trials in children (10). In the model used in our laboratory, a low inoculum (5 to 50 CFU in 0.1 ml) is injected directly into the middle ear via the superior bulla (21). Middle ear disease in the animals is evaluated longitu...

show abstract

A comparative study of azithromycin and amoxycillin in paediatric patients with acute otitis media

Cited by 26 publications

References 0 publications

Treatment of Acute Otitis Media With a Shortened Course of Antibiotics

Treatment of Acute Otitis Media With a Shortened Course of Antibiotics

A pilot study of single-dose azithromycin versus three-day azithromycin or single-dose ceftriaxone for uncomplicated acute otitis media in children

Experimental Acute Otitis Media Due to NontypeableHaemophilus influenzae: Comparison of High and Low Azithromycin Doses with Placebo

Contact Info

Product

Resources

About