Guidelines of American associations of paediatrics suggests that ceftriaxone, cefprozil and cefuroxime axetil can be used as alternative options for treatment of PAOM in under two years as well as over two years of age . Against this backdrop, the present study was conducted to compare the efficacy and safety of cefpodoxime with amoxicillin-clavulanate potassium in PAOM in children below two years. A randomized double blind clinical trial could not be conducted due to lack of resources. Secondly, the sample sized of our study was relatively small. We conducted this study to provide information to paediatricians on the comparative efficacy of these two antibiotics as initial antibiotics for children with PAOM below two years of age based on clinical assessment scores. Intra group analysis of AOM-SOS score at baseline (day 0) against day 5 and day 10 scores showed a highly significant decrease in both groups and clinically significant improvement in the signs and symptoms of the PAOM.
- Guidelines of American associations of paediatrics suggests that ceftriaxone, cefprozil and cefuroxime axetil can be used as alternative options for treatment of PAOM in under two years as well as over two years of age .
- Children fulfilling the selection criteria, were randomly divided into two treatment groups.
- The mean age of children was 1.8 years and 1.6 years in the Group A and B respectively.
- Current research is focused towards the latest development in scientific understanding of AOM and its proper management.
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Future trials are required to assess relapse rates and bacteriological cure to provide more scientific insight into the study. Children fulfilling the selection criteria, were randomly divided into two treatment groups. Children in Group A received amoxicillin-clavulanate potassium 30 mg/kg/day (amoxicillin base) in two divided doses for 10 days.
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The causality analysis was done as per the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria . The results of this prospective study showed that a 10-day course of cefpodoxime is therapeutically comparable to amoxicillin-clavulanate potassium in terms of both efficacy and safety for the treatment of PAOM in children below two years. Cefpodoxime is a wide spectrum oral third generation cephalosporin. It is active against aerobic Gram-positive and Gram-negative bacteria as well as anaerobic organisms.
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The four children, who were excluded from the study, were given adequate treatment accordingly. The mean age of children was 1.8 years and 1.6 years in the Group A and B respectively. Almost, 73.3% boys in Group A and 60% boys in Group B were there. 2 The interest rate and Annual Percentage Yield (APY) will be disclosed in your account-opening documents, which you will receive after funding your Account. The interest rate and APY for your CD will be fixed and will either be (i) the rate reflected at application submission or (ii) the rate being offered when your CD is funded, whichever is higher. All CDs must be funded within 60 calendar days from the time we approve your application or will be subject to closure.
Current research is focused towards the latest development in scientific understanding of AOM and its proper management. Improper treatment and untreated cases of AOM can lead to serious complications, especially in children under two years. The key factor to successful treatment is the choice of specific antimicrobial agent. Gradual increase of antimicrobial resistance and costs of antimicrobial therapy have emphasized the need of judicious and rational use of antimicrobial drugs 1,2.
- Gradual increase of antimicrobial resistance and costs of antimicrobial therapy have emphasized the need of judicious and rational use of antimicrobial drugs 1,2.
- So, it can be suggested that both cefpodoxime and amoxicillin-clavulanate potassium are equally effective in treatment of PAOM.
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- These were mild AEs and did not require modification of drug therapy.
Our study showed that cefpodoxime and amoxicillin-clavulanate potassium are equally effective in clinically diagnosed cases of PAOM, both in terms of efficacy and safety. After treatment with a 10-day course, the clinical success rates were comparable i.e., 88.2% in the cefpodoxime group and 93.8% in the amoxicillin-clavulanate potassium group. The incidence of AEs was also minimal i.e., two in the amoxicillin-clavulanate potassium group.
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Thus, it can be suggested that both cefpodoxime and amoxicillin-clavulanate potassium are effective in treatment of PAOM. Inter group analysis of the AOM-SOS scores showed that there was no statistically significant difference in the baseline, day 5 and day 10 AOM-SOS scores. So, it can be suggested that both cefpodoxime and amoxicillin-clavulanate potassium are equally effective in treatment of PAOM. Suspected bacteria and their antibiotic susceptibility pattern guide the choice of antimicrobial agents for treatment of AOM. Common bacteria known to cause AOM in children are Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis . However, there is relative paucity of data on middle ear pathogens as tympanocentesis is not routinely performed in children with AOM.
The mean age of the children in cefaclor group was 5.74 years and in amoxicillin-clavulanate potassium group was 4.93 years which is higher than our study group . Intravenous or intra-muscular administration of ceftriaxone is recommended in treatment of PAOM if amoxicillin is used within last one month for treatment of same condition . But, there is no such guideline available in India and till date no study was conducted to compare cefpodoxime, an oral third generation cephalosporin in PAOM in children below two years. Our study shows that cefpodoxime and amoxicillin-clavulanate are equally effective in clinically diagnosed cases of PAOM, both in terms of effectiveness and safety in children below two years.
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The study conducted by Hoberman A et al., evaluated children between 6 to 23 months of age with AOM. They reported that treatment with amoxicillin-clavulanate potassium for 10 days resulted in quick recovery and decreased signs and symptoms of AOM on otoscopic examination . The result proved that amoxicillin-clavulanate potassium is the first line drug for the treatment of PAOM in children below two years. Few studies have evaluated efficacy of oral cephalosporins in treatment of PAOM 14-17.
Acute Otitis Media (AOM) is one of the frequently diagnosed diseases in children below two years. Amoxicillin-clavulanate potassium amxoline is the first line drug in treatment of Paediatric AOM (PAOM). Cefpodoxime has good antimicrobial activity against various types of microorganisms that include causative microorganisms of PAOM.
High dose amoxicillin exceed the Minimum Inhibitory Concentration (MIC) of S. A 4 to 6 days treatment with high dose amoxicillin and clavulanate potassium has been found effective to eradicate S. On the other side, the data show that 58% to 82% of H. Influenzae are susceptible to regular and high dose amoxicillin.
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