Amoxicillin-sulbactam versus amoxicillin-clavulanic acid for the treatment of non-recurrent-acute otitis media in Argentinean children
Streptococcus pneumoniae (Sp) and Haemophilus influenzae (Hi) are the leading bacterial cause of acute otitis media (AOM), having the nasopharynx (NP) as their reservoir. In October 2001 we began a prospective, multicenter, randomized, evaluator blind study, comparing the efficacy of amoxicillin-sul...
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| Veröffentlicht in: | International journal of pediatric otorhinolaryngology 2005-09, Vol.69 (9), p.1225-1233 |
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| creator | Casellas, Javier María Israele, Víctor Marín, Marcelo Ishida, María T. Heguilen, Ricardo Soutric, Jorge Arenoso, Héctor Sibbald, Andrés Stamboulian, Daniel |
| description | Streptococcus pneumoniae (Sp) and
Haemophilus influenzae (Hi) are the leading bacterial cause of acute otitis media (AOM), having the nasopharynx (NP) as their reservoir. In October 2001 we began a prospective, multicenter, randomized, evaluator blind study, comparing the efficacy of amoxicillin-sulbactam (Ax/S) and amoxicillin-clavulanic acid (Ax/C) for the treatment of non-recurrent AOM (nr-AOM). Both antimicrobial susceptibility (AS) to Ax/S and Ax/C from Sp and Hi carried by study children (aged 6–48 months with nr-AOM) and, clinical outcome after treatment with high dose of either Ax/C (7:1) or Ax/S (4:1) (amoxicillin dose: 80
mg/(kg
day), b.i.d. for 10 days) were assessed. Nasal cultures (NCs) were taken at Day 0. Follow-up NCs, were done only for Sp carriers. On final analysis 247/289 pts (85.5%) were fully evaluable (120
Ax/S and 127
Ax/C). NP carriage rate of Hi and Sp at Day 0 was 32.2% (93/289 pts) and 28.7% (83/289 pts), respectively. Persistent Sp carriage was detected only in 2 pts. Hi betalactamase positive rate was 13% (12/93). MICs for Ax/S and Ax/C were identical when tested against Sp and Hi isolates (range
≤
0.016–1.0 and ≤0.016–0.25
mg/L, respectively). Clinical efficacy at Days 12–14 and 28–42 were 98.3% (115/117) and 94.2% (97/103) for Ax/S; and 98.3% (115/117) and 95.1% (98/103) for Ax/C, respectively (pNS). We conclude, that Sp and Hi isolated from NCs of nr-AOM pts were highly sensitive to both drugs and correlated with high clinical efficacy rate. |
| doi_str_mv | 10.1016/j.ijporl.2005.03.016 |
| format | Article |
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Haemophilus influenzae (Hi) are the leading bacterial cause of acute otitis media (AOM), having the nasopharynx (NP) as their reservoir. In October 2001 we began a prospective, multicenter, randomized, evaluator blind study, comparing the efficacy of amoxicillin-sulbactam (Ax/S) and amoxicillin-clavulanic acid (Ax/C) for the treatment of non-recurrent AOM (nr-AOM). Both antimicrobial susceptibility (AS) to Ax/S and Ax/C from Sp and Hi carried by study children (aged 6–48 months with nr-AOM) and, clinical outcome after treatment with high dose of either Ax/C (7:1) or Ax/S (4:1) (amoxicillin dose: 80
mg/(kg
day), b.i.d. for 10 days) were assessed. Nasal cultures (NCs) were taken at Day 0. Follow-up NCs, were done only for Sp carriers. On final analysis 247/289 pts (85.5%) were fully evaluable (120
Ax/S and 127
Ax/C). NP carriage rate of Hi and Sp at Day 0 was 32.2% (93/289 pts) and 28.7% (83/289 pts), respectively. Persistent Sp carriage was detected only in 2 pts. Hi betalactamase positive rate was 13% (12/93). MICs for Ax/S and Ax/C were identical when tested against Sp and Hi isolates (range
≤
0.016–1.0 and ≤0.016–0.25
mg/L, respectively). Clinical efficacy at Days 12–14 and 28–42 were 98.3% (115/117) and 94.2% (97/103) for Ax/S; and 98.3% (115/117) and 95.1% (98/103) for Ax/C, respectively (pNS). We conclude, that Sp and Hi isolated from NCs of nr-AOM pts were highly sensitive to both drugs and correlated with high clinical efficacy rate.</description><identifier>ISSN: 0165-5876</identifier><identifier>EISSN: 1872-8464</identifier><identifier>DOI: 10.1016/j.ijporl.2005.03.016</identifier><identifier>PMID: 16061111</identifier><language>eng</language><publisher>Ireland: Elsevier Ireland Ltd</publisher><subject><![CDATA[Acute Disease ; Acute otitis media ; Amoxicillin - administration & dosage ; Amoxicillin - therapeutic use ; Amoxicillin-clavulanic acid ; Amoxicillin-Potassium Clavulanate Combination - administration & dosage ; Amoxicillin-Potassium Clavulanate Combination - therapeutic use ; Amoxicillin-sulbactam ; Anti-Bacterial Agents - administration & dosage ; Anti-Bacterial Agents - therapeutic use ; Argentina ; Carrier State - drug therapy ; Carrier State - microbiology ; Child, Preschool ; Children ; Drug Administration Schedule ; Drug Combinations ; Female ; Haemophilus Infections - drug therapy ; Haemophilus influenzae - isolation & purification ; Humans ; Infant ; Male ; Otitis Media - drug therapy ; Otitis Media - microbiology ; Pneumococcal Infections - drug therapy ; Prospective Studies ; Single-Blind Method ; Streptococcus pneumoniae - isolation & purification ; Sulbactam - administration & dosage ; Sulbactam - therapeutic use ; Treatment Outcome]]></subject><ispartof>International journal of pediatric otorhinolaryngology, 2005-09, Vol.69 (9), p.1225-1233</ispartof><rights>2005 Elsevier Ireland Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c360t-1296e45a9361a972cca626d4fbd8a1c92bcd3c002ed995a15ebfa16473f3335b3</citedby><cites>FETCH-LOGICAL-c360t-1296e45a9361a972cca626d4fbd8a1c92bcd3c002ed995a15ebfa16473f3335b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ijporl.2005.03.016$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16061111$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Casellas, Javier María</creatorcontrib><creatorcontrib>Israele, Víctor</creatorcontrib><creatorcontrib>Marín, Marcelo</creatorcontrib><creatorcontrib>Ishida, María T.</creatorcontrib><creatorcontrib>Heguilen, Ricardo</creatorcontrib><creatorcontrib>Soutric, Jorge</creatorcontrib><creatorcontrib>Arenoso, Héctor</creatorcontrib><creatorcontrib>Sibbald, Andrés</creatorcontrib><creatorcontrib>Stamboulian, Daniel</creatorcontrib><title>Amoxicillin-sulbactam versus amoxicillin-clavulanic acid for the treatment of non-recurrent-acute otitis media in Argentinean children</title><title>International journal of pediatric otorhinolaryngology</title><addtitle>Int J Pediatr Otorhinolaryngol</addtitle><description>Streptococcus pneumoniae (Sp) and
Haemophilus influenzae (Hi) are the leading bacterial cause of acute otitis media (AOM), having the nasopharynx (NP) as their reservoir. In October 2001 we began a prospective, multicenter, randomized, evaluator blind study, comparing the efficacy of amoxicillin-sulbactam (Ax/S) and amoxicillin-clavulanic acid (Ax/C) for the treatment of non-recurrent AOM (nr-AOM). Both antimicrobial susceptibility (AS) to Ax/S and Ax/C from Sp and Hi carried by study children (aged 6–48 months with nr-AOM) and, clinical outcome after treatment with high dose of either Ax/C (7:1) or Ax/S (4:1) (amoxicillin dose: 80
mg/(kg
day), b.i.d. for 10 days) were assessed. Nasal cultures (NCs) were taken at Day 0. Follow-up NCs, were done only for Sp carriers. On final analysis 247/289 pts (85.5%) were fully evaluable (120
Ax/S and 127
Ax/C). NP carriage rate of Hi and Sp at Day 0 was 32.2% (93/289 pts) and 28.7% (83/289 pts), respectively. Persistent Sp carriage was detected only in 2 pts. Hi betalactamase positive rate was 13% (12/93). MICs for Ax/S and Ax/C were identical when tested against Sp and Hi isolates (range
≤
0.016–1.0 and ≤0.016–0.25
mg/L, respectively). Clinical efficacy at Days 12–14 and 28–42 were 98.3% (115/117) and 94.2% (97/103) for Ax/S; and 98.3% (115/117) and 95.1% (98/103) for Ax/C, respectively (pNS). We conclude, that Sp and Hi isolated from NCs of nr-AOM pts were highly sensitive to both drugs and correlated with high clinical efficacy rate.</description><subject>Acute Disease</subject><subject>Acute otitis media</subject><subject>Amoxicillin - administration & dosage</subject><subject>Amoxicillin - therapeutic use</subject><subject>Amoxicillin-clavulanic acid</subject><subject>Amoxicillin-Potassium Clavulanate Combination - administration & dosage</subject><subject>Amoxicillin-Potassium Clavulanate Combination - therapeutic use</subject><subject>Amoxicillin-sulbactam</subject><subject>Anti-Bacterial Agents - administration & dosage</subject><subject>Anti-Bacterial Agents - therapeutic use</subject><subject>Argentina</subject><subject>Carrier State - drug therapy</subject><subject>Carrier State - microbiology</subject><subject>Child, Preschool</subject><subject>Children</subject><subject>Drug Administration Schedule</subject><subject>Drug Combinations</subject><subject>Female</subject><subject>Haemophilus Infections - drug therapy</subject><subject>Haemophilus influenzae - isolation & purification</subject><subject>Humans</subject><subject>Infant</subject><subject>Male</subject><subject>Otitis Media - drug therapy</subject><subject>Otitis Media - microbiology</subject><subject>Pneumococcal Infections - drug therapy</subject><subject>Prospective Studies</subject><subject>Single-Blind Method</subject><subject>Streptococcus pneumoniae - isolation & purification</subject><subject>Sulbactam - administration & dosage</subject><subject>Sulbactam - therapeutic use</subject><subject>Treatment Outcome</subject><issn>0165-5876</issn><issn>1872-8464</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kMFu1DAQhi0EotvCGyDkE7cEO06c5IK0qgpFqsQFztZkMqFeOfZiOyt4AZ4bV7sSnJjLSP_8M6P_Y-yNFLUUUr8_1PZwDNHVjRBdLVRdxGdsJ4e-qYZWt8_Zrihd1Q29vmLXKR2EkL3oupfsSmqhZakd-71fw0-L1jnrq7S5CTDDyk8U05Y4_DNEB6fNgbfIAe3MlxB5fiSeI0FeyWceFu6DryLhFmMRKsAtEw_ZZpv4SrMFbj3fx-9laD2B5_ho3Vy8r9iLBVyi15d-w759vPt6e189fPn0-Xb_UKHSIleyGTW1HYxKSxj7BhF0o-d2meYBJI7NhLNCIRqax7ED2dG0gNRtrxalVDepG_bufPcYw4-NUjarTUiu5KKwJaOHVummHYuxPRsxhpQiLeYY7Qrxl5HCPPE3B3Pmb574G6FMEcva28v9bSqB_y5dgBfDh7OBSsqTpWgSWvJY4BRu2czB_v_DH4Y9nFI</recordid><startdate>20050901</startdate><enddate>20050901</enddate><creator>Casellas, Javier María</creator><creator>Israele, Víctor</creator><creator>Marín, Marcelo</creator><creator>Ishida, María T.</creator><creator>Heguilen, Ricardo</creator><creator>Soutric, Jorge</creator><creator>Arenoso, Héctor</creator><creator>Sibbald, Andrés</creator><creator>Stamboulian, Daniel</creator><general>Elsevier Ireland Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>8BM</scope></search><sort><creationdate>20050901</creationdate><title>Amoxicillin-sulbactam versus amoxicillin-clavulanic acid for the treatment of non-recurrent-acute otitis media in Argentinean children</title><author>Casellas, Javier María ; Israele, Víctor ; Marín, Marcelo ; Ishida, María T. ; Heguilen, Ricardo ; Soutric, Jorge ; Arenoso, Héctor ; Sibbald, Andrés ; Stamboulian, Daniel</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c360t-1296e45a9361a972cca626d4fbd8a1c92bcd3c002ed995a15ebfa16473f3335b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Acute Disease</topic><topic>Acute otitis media</topic><topic>Amoxicillin - administration & dosage</topic><topic>Amoxicillin - therapeutic use</topic><topic>Amoxicillin-clavulanic acid</topic><topic>Amoxicillin-Potassium Clavulanate Combination - administration & dosage</topic><topic>Amoxicillin-Potassium Clavulanate Combination - therapeutic use</topic><topic>Amoxicillin-sulbactam</topic><topic>Anti-Bacterial Agents - administration & dosage</topic><topic>Anti-Bacterial Agents - therapeutic use</topic><topic>Argentina</topic><topic>Carrier State - drug therapy</topic><topic>Carrier State - microbiology</topic><topic>Child, Preschool</topic><topic>Children</topic><topic>Drug Administration Schedule</topic><topic>Drug Combinations</topic><topic>Female</topic><topic>Haemophilus Infections - drug therapy</topic><topic>Haemophilus influenzae - isolation & purification</topic><topic>Humans</topic><topic>Infant</topic><topic>Male</topic><topic>Otitis Media - drug therapy</topic><topic>Otitis Media - microbiology</topic><topic>Pneumococcal Infections - drug therapy</topic><topic>Prospective Studies</topic><topic>Single-Blind Method</topic><topic>Streptococcus pneumoniae - isolation & purification</topic><topic>Sulbactam - administration & dosage</topic><topic>Sulbactam - therapeutic use</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Casellas, Javier María</creatorcontrib><creatorcontrib>Israele, Víctor</creatorcontrib><creatorcontrib>Marín, Marcelo</creatorcontrib><creatorcontrib>Ishida, María T.</creatorcontrib><creatorcontrib>Heguilen, Ricardo</creatorcontrib><creatorcontrib>Soutric, Jorge</creatorcontrib><creatorcontrib>Arenoso, Héctor</creatorcontrib><creatorcontrib>Sibbald, Andrés</creatorcontrib><creatorcontrib>Stamboulian, Daniel</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>ComDisDome</collection><jtitle>International journal of pediatric otorhinolaryngology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Casellas, Javier María</au><au>Israele, Víctor</au><au>Marín, Marcelo</au><au>Ishida, María T.</au><au>Heguilen, Ricardo</au><au>Soutric, Jorge</au><au>Arenoso, Héctor</au><au>Sibbald, Andrés</au><au>Stamboulian, Daniel</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Amoxicillin-sulbactam versus amoxicillin-clavulanic acid for the treatment of non-recurrent-acute otitis media in Argentinean children</atitle><jtitle>International journal of pediatric otorhinolaryngology</jtitle><addtitle>Int J Pediatr Otorhinolaryngol</addtitle><date>2005-09-01</date><risdate>2005</risdate><volume>69</volume><issue>9</issue><spage>1225</spage><epage>1233</epage><pages>1225-1233</pages><issn>0165-5876</issn><eissn>1872-8464</eissn><abstract>Streptococcus pneumoniae (Sp) and
Haemophilus influenzae (Hi) are the leading bacterial cause of acute otitis media (AOM), having the nasopharynx (NP) as their reservoir. In October 2001 we began a prospective, multicenter, randomized, evaluator blind study, comparing the efficacy of amoxicillin-sulbactam (Ax/S) and amoxicillin-clavulanic acid (Ax/C) for the treatment of non-recurrent AOM (nr-AOM). Both antimicrobial susceptibility (AS) to Ax/S and Ax/C from Sp and Hi carried by study children (aged 6–48 months with nr-AOM) and, clinical outcome after treatment with high dose of either Ax/C (7:1) or Ax/S (4:1) (amoxicillin dose: 80
mg/(kg
day), b.i.d. for 10 days) were assessed. Nasal cultures (NCs) were taken at Day 0. Follow-up NCs, were done only for Sp carriers. On final analysis 247/289 pts (85.5%) were fully evaluable (120
Ax/S and 127
Ax/C). NP carriage rate of Hi and Sp at Day 0 was 32.2% (93/289 pts) and 28.7% (83/289 pts), respectively. Persistent Sp carriage was detected only in 2 pts. Hi betalactamase positive rate was 13% (12/93). MICs for Ax/S and Ax/C were identical when tested against Sp and Hi isolates (range
≤
0.016–1.0 and ≤0.016–0.25
mg/L, respectively). Clinical efficacy at Days 12–14 and 28–42 were 98.3% (115/117) and 94.2% (97/103) for Ax/S; and 98.3% (115/117) and 95.1% (98/103) for Ax/C, respectively (pNS). We conclude, that Sp and Hi isolated from NCs of nr-AOM pts were highly sensitive to both drugs and correlated with high clinical efficacy rate.</abstract><cop>Ireland</cop><pub>Elsevier Ireland Ltd</pub><pmid>16061111</pmid><doi>10.1016/j.ijporl.2005.03.016</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0165-5876 |
| ispartof | International journal of pediatric otorhinolaryngology, 2005-09, Vol.69 (9), p.1225-1233 |
| issn | 0165-5876 1872-8464 |
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| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Acute Disease Acute otitis media Amoxicillin - administration & dosage Amoxicillin - therapeutic use Amoxicillin-clavulanic acid Amoxicillin-Potassium Clavulanate Combination - administration & dosage Amoxicillin-Potassium Clavulanate Combination - therapeutic use Amoxicillin-sulbactam Anti-Bacterial Agents - administration & dosage Anti-Bacterial Agents - therapeutic use Argentina Carrier State - drug therapy Carrier State - microbiology Child, Preschool Children Drug Administration Schedule Drug Combinations Female Haemophilus Infections - drug therapy Haemophilus influenzae - isolation & purification Humans Infant Male Otitis Media - drug therapy Otitis Media - microbiology Pneumococcal Infections - drug therapy Prospective Studies Single-Blind Method Streptococcus pneumoniae - isolation & purification Sulbactam - administration & dosage Sulbactam - therapeutic use Treatment Outcome |
| title | Amoxicillin-sulbactam versus amoxicillin-clavulanic acid for the treatment of non-recurrent-acute otitis media in Argentinean children |
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