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Michael E. Pichichero - One of the best experts on this subject based on the ideXlab platform.
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pharmacodynamic analysis and clinical trial of amoxicillin sprinkle administered once daily for 7 days compared to Penicillin V Potassium administered four times daily for 10 days in the treatment of tonsillopharyngitis due to streptococcus pyogenes
Antimicrobial Agents and Chemotherapy, 2008Co-Authors: Michael E. Pichichero, Janet R Casey, Stan L Block, R Guttendorf, H Flanner, D Markowitz, S ClausenAbstract:An a priori pharmacokinetic/pharmacodynamic (PK/PD) target of 40% daily time aboVe the MIC (T >MIC; based on the MIC90 of 0.06 μg/ml for Streptococcus pyogenes reported in the literature) was shown to be achieVable in a phase 1 study of 23 children with a once-daily (QD) modified-release, multiparticulate formulation of amoxicillin (amoxicillin sprinkle). The daily T >MIC achieVed with the QD amoxicillin sprinkle formulation was comparable to that achieVed with a four-times-daily (QID) Penicillin VK suspension. An inVestigator-blinded, randomized, parallel-group, multicenter study inVolVing 579 children 6 months to 12 years old with acute streptococcal tonsillopharyngitis was then undertaken. Children were randomly assigned 1:1 to receiVe either the amoxicillin sprinkle (475 mg for ages 6 months to 4 years, 775 mg for ages 5 to 12 years) QD for 7 days or 10 mg/kg of body weight of Penicillin VK QID for 10 days (up to the maximum dose of 250 mg QID). Unexpectedly, the rates of bacteriological eradication at the test of cure were 65.3% (132/202) for the amoxicillin sprinkle and 68.0% (132/194) for Penicillin VK (95% confidence interVal, −12.0% to 6.6%). Thus, neither antibiotic regimen met the minimum criterion of ≥85% eradication ordinarily required by the U.S. FDA for first-line treatment of tonsillopharyngitis due to S. pyogenes. The results of subgroup analyses across demographic characteristics and current infection characteristics and by age/weight categories were consistent with the primary-efficacy result. The clinical cure rates for amoxicillin sprinkle and Penicillin VK were 86.1% (216/251) and 91.9% (204/222), respectiVely (95% confidence interVal, −11.6% to −0.4%). The results of a post hoc PD analysis suggested that a requirement for 60% daily T >MIC90 more accurately predicted the obserVed high failure rates for bacteriologic eradication with the amoxicillin sprinkle and Penicillin VK suspension studied. Based on the association between longer treatment courses and maximal bacterial eradication rates reported in the literature, an alternatiVe composite PK/PD target taking into consideration the duration of therapy, or total T >MIC, was considered and proVides an alternatiVe explanation for the obserVed failure rate of amoxicillin sprinkle.
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Incidence of Streptococcal Carriers in PriVate Pediatric Practice
Archives of pediatrics & adolescent medicine, 1999Co-Authors: Michael E. Pichichero, Steven M. Marsocci, A. Marie Lynd Murphy, William Hoeger, John L. Green, Ann SorrentoAbstract:ObjectiVe: To determine the incidence of group A bhemolytic streptococcus (GABHS) carriers in children who are well, in children seen with presumed and documented Viral illnesses with sore throat, and in children after treatment of acute GABHS tonsillopharyngitis with 10 days of oral Penicillin V Potassium, oral cephalosporins, or macrolides. Methods: ProspectiVe collection of clinical and microbiologic data from October 1996 to June 1997 in a priVate pediatric practice were obtained from children who were asymptomatic and well, from children with both presumed (and documented) Viral sore throats, and from children who had completed a full antibiotic treatment course for acute GABHS throat infections. Results: The incidence of GABHS carriers was 2.5% among well children (n = 227), 4.4% among children with upper respiratory tract infections including sore throat of presumed Viral etiology (n = 296), and 6.9% among children with upper respiratory tract infections including sore throat from whom Viruses were isolated (n = 87). Following 10 days’ treatment of acute GABHS tonsillopharyngitis, 81 (11.3%) of 718 children treated with Penicillin, 22 (4.3%) of 508 children treated with an oral cephalosporin, and 10 (7.1%) of 140 children treated w ith a m acrolide w ere G ABHS c arriers (P,.001). Conclusions: A small percentage of children seen in priVate pediatric practices who are well or who haVe apparent Viral upper respiratory tract infections with sore throat are GABHS carriers. Penicillin treatment of acute GABHS tonsillopharyngitis results in a higher GABHS carriage rate than occurs following treatment with cephalosporins and macrolides. Arch Pediatr Adolesc Med. 1999;153:624-628
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Variables influencing Penicillin treatment outcome in streptococcal tonsillopharyngitis
Archives of pediatrics & adolescent medicine, 1999Co-Authors: Michael E. Pichichero, Steven M. Marsocci, A. Marie Lynd Murphy, William Hoeger, Anne B. Francis, Vladimir DragalinAbstract:ObjectiVe To examine whether Penicillin treatment success for group A β-hemolytic streptococcal tonsillopharyngitis is influenced by patient age, number of days ill prior to initiation of treatment, number of prior episodes, season, total dosage (milligrams per kilogram), and frequency of administration (2 Vs 3 times daily). Methods Four hundred seVenty-eight children, adolescents, and young adults aged 2 to 21 years with acute symptoms compatible with the clinical diagnosis of group A β-hemolytic streptococcal tonsillopharyngitis and a positiVe streptococcus rapid antigen detection test result were enrolled (intent-to-treat group). Patients were randomly assigned to receiVe Penicillin V Potassium, 250 mg 3 times daily (n=239) or 500 mg 2 times daily (n=239). Randomization was independent of patient body weight and treatment was for 10 days with both regimens. Follow-up examinations occurred, and cultures were obtained at 14 to 21 days after the initiation of antibiotic therapy; those with group A β-hemolytic streptococcus isolated from a throat culture and who returned for follow-up were assessed for outcome (n=359). Results Using a logistic regression analysis with a stepwise Variable selection, we found the major Variables associated with Penicillin treatment success to be the number of days ill prior to initiation of treatment ( P =.001; odds ratio, 1.55 [95% confidence interVal, 1.2-2.1]) and the age of the child when infected ( P =.004; odds ratio, 1.14 [95% confidence interVal, 1.05-1.25]). The number of prior episodes within the preceding year, the season, the total daily Penicillin dose (range, 8-76 mg/kg), and 2 Vs 3 times daily dosing did not significantly alter treatment outcome. Conclusion Treatment after 2 days of illness and of adolescent patients increases Penicillin treatment success for group A β-hemolytic streptococcal tonsillopharyngitis.
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A Study of 5-Day Cefdinir Treatment for Streptococcal Pharyngitis in Children
Archives of pediatrics & adolescent medicine, 1997Co-Authors: Kenneth J. Tack, James Hedrick, Edward P. Rothstein, Mary Anne Nemeth, Constance H. Keyserling, Michael E. PichicheroAbstract:ObjectiVe: To compare the safety and efficacy of a 5-day regimen of cefdinir with those of a conVentional 10-day regimen of Penicillin V for the treatment of streptococcal pharyngitis in children. Design: InVestigator-blind, randomized controlled trial. Setting: Primary care, ambulatory. Patients: Children aged 1 to 12 years with signs and symptoms of pharyngitis and a positiVe result on a rapid screening test forStreptococcus pyogenes(ie, a conVenience sample). Four hundred eighty-two patients were enrolled in the study, and 440 were clinically and microbiologically eValuable. The most common reasons patients were noneValuable were failure to return for specified Visits and noncompliance with the administration of the medication; 2 patients receiVing Penicillin V discontinued use of the drug because of adVerse eVents. InterVention: Patients were randomized to receiVe either 7-mg/kg cefdinir, twice daily, for 5 days or 10-mg/kg Penicillin V Potassium, 4 times daily, for 10 days. Main Outcome Measures: The eradication ofS pyogenesand the clinical cure of the signs and symptoms of pharyngitis, both determined 5 to 10 days after the completion of therapy. Results: Streptococcus pyogeneswas eradicated in 201 (90%) of the 224 patients receiVing cefdinir and 155 (72%) of the 216 patients receiVing Penicillin V (95% confidence interVal [CI], 10.7%-25.1%;P Conclusions: A 5-day regimen of cefdinir eradicated a higher proportion ofS pyogenesthan a 10-day regimen of Penicillin V. No difference was noted between the regimens for clinical outcomes or adVerse eVent rates. Arch Pediatr Adolesc Med. 1997;151:45-49
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effectiVe short course treatment of acute group a β hemolytic streptococcal tonsillopharyngitis ten days of Penicillin V Vs 5 days or 10 days of cefpodoxime therapy in children
JAMA Pediatrics, 1994Co-Authors: Michael E. Pichichero, Manford W Gooch, William J Rodriguez, Jeffrey L Blumer, Stephen C Aronoff, Richard F Jacobs, James M MusserAbstract:ObjectiVe: To compare bacteriologic and clinical efficacy and safety of 10 Vs 5 days of cefpodoxime proxetil Vs 10 days of Penicillin V Potassium for the treatment of acute group A β-hemolytic streptococcal tonsillopharyngitis in children. Design: ProspectiVe, randomized, obserVer-blind, multicenter study. Patients/InterVentions: Four hundred eighty-four children (age range, 2 to 17 years) with signs and symptoms of acute tonsillopharyngitis were enrolled; 377 had a positiVe throat culture for group A β-hemolytic streptococci and were fully eValuable. One hundred twenty-one patients receiVed cefpodoxime once a day for 10 days, 126 receiVed cefpodoxime twice a day for 5 days, and 130 receiVed Penicillin V three times a day for 10 days. Results: Cefpodoxime for 10 days Vs cefpodoxime for 5 days Vs Penicillin V for 10 days produced bacteriologic eradication at the end of therapy in 95%, 90%, and 78% of the patients, respectiVely. The 10- and 5-day cefpodoxime treatment regimens were more efficacious than Penicillin V ( P =.003 and P =.02, respectiVely). The cumulatiVe bacteriologic failure rate among assessable patients by the 32- to 38-day posttreatment Visit was 20 (17%) of 121 patients who were treated with cefpodoxime for 10 days, 24 (19%) of 125 patients who were treated with cefpodoxime for 5 days, and 45 (35%) of 130 patients who were treated with Penicillin V for 10 days ( P =.001 and P =.005, respectiVely). Clinical cure or improVement was obserVed at the end of therapy in 96%, 94%, and 91% of the patients, respectiVely ( P =not significant). AdVerse eVents were infrequent and similar in all three treatment groups, with minor gastrointestinal side effects predominating. Conclusions: FiVe days of treatment with cefpodoxime is as efficacious in bacteriologic eradication and clinical response (cure plus improVement) as 10 days of cefpodoxime therapy, and both cefpodoxime regimens produced superior bacteriologic efficacy compared with a 10-day regimen of Penicillin V in the treatment of group A β-hemolytic streptococcal tonsillopharyngitis in children. (Arch Pediatr Adoles Med. 1994;148:1053-1060)
Elliott Vichinsky - One of the best experts on this subject based on the ideXlab platform.
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Discontinuing Penicillin prophylaxis in children with sickle cell anemia
The Journal of pediatrics, 1995Co-Authors: John M. Falletta, Joel Verter, Gerald M Woods, Charles H Pegelow, Rathi V Iyer, George R. Buchanan, Scott T. Miller, C. Tate Holbrook, Thomas R. Kinney, Elliott VichinskyAbstract:Abstract ObjectiVe : To eValuate the consequences of discontinuing Penicillin prophylaxis at 5 years of age in children with sickle cell anemia who had receiVed prophylactic Penicillin for much of their liVes. Design : Randomized, double-blind, placebo-controlled trial. Setting : Eighteen teaching hospitals throughout the United States. Patients : Children with sickle cell anemia (hemoglobin SS or hemoglobin S β 0 -thalassemia) who had receiVed prophylactic Penicillin therapy for at least 2 years immediately before their fifth birthday and had receiVed the 23-Valent pneumococcal Vaccine between 2 and 3 years of age and again at the time of randomization. Of 599 potential candidates, 400 were randomly selected and followed for an aVerage of 3.2 years. InterVentions : After randomization, patients receiVed the study medication twice daily-either Penicillin V Potassium, 250 mg, or an identical placebo tablet. Patients were either seen in the clinic or contacted eVery 3 months thereafter for an interVal history and dispensing of the study drug. A physical examination was scheduled eVery 6 months. Main outcome measures : The primary end point was a comparison of the incidence of bacteremia or meningitis caused by Streptococcus pneumoniae in children continuing Penicillin prophylaxis Versus those receiVing the placebo. Results : Six children had a systemic infection caused by S. pneumoniae , four in the placebo group (2.0%; 95% confidence interVal 0.5%, 5.0%) and two in the continued Penicillin prophylaxis group (1.0%; 95% confidence interVal 0.1%, 3.6%), with a relatiVe risk of 0.5 (95% confidence interVal 0.1, 2.7). All inVasiVe isolates were either serotype 6(A or B) or serotype 23F. Four of the isolates were Penicillin susceptible, and two (one from each treatment group) were Penicillin and multiply antibiotic resistant. AdVerse effects of the study drug were reported for three patients (nausea, Vomiting, or both), one of whom was in the placebo group. Conclusion : Children with sickle cell anemia who haVe not had a prior seVere pneumococcal infection or a splenectomy and are receiVing comprehensiVe care may safely stop prophylactic Penicillin therapy at 5 years of age. Parents must be aggressiVely counseled to seek medical attention for all febrile eVents in children with sickle cell anemia. (J PEDIATR 1995;127:685-90)
Mauro Grossi - One of the best experts on this subject based on the ideXlab platform.
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Compliance With Penicillin Prophylaxis in Patients With Sickle Cell Disease
Archives of pediatrics & adolescent medicine, 1998Co-Authors: Stephen J. Teach, Kathleen A. Lillis, Mauro GrossiAbstract:ObjectiVe To assess factors related to compliance with Penicillin prophylaxis among patients with sickle cell disease. Design ProspectiVe case series. Setting Urban pediatric medical center where uniVersal Penicillin prophylaxis is recommended for all patients with any sickle cell hemoglobinopathy independent of age. Participants Eligible patients with sickle cell hemoglobinopathies were enrolled in either the emergency department or the sickle cell clinic. Main Outcome Measures Compliance was assessed by structured interView and by urine assay with an established method (Micrococcus luteuswith disk diffusion) that detects excreted Penicillin up to 15 hours after each dose administration. Results Of the 159 patients actiVely followed up at the sickle cell center, 123 (77.3%) eligible patients were enrolled. Reported compliance by structured interView (≥1 dose of Penicillin V Potassium within 15 hours of enrollment) was 83 of 123 patients (67.5%; 95% confidence interVal, 59.2%-75.8%), whereas measured compliance as determined by urine assay was 53 of 123 patients (43.1%; 95% confidence interVal, 31.3%-51.7%). Measured compliance was significantly greater in patients younger than 5 years than in those older than 5 years (25/41 [61%] Vs 28/82 [34%], respectiVely;P=.004), and was significantly greater in patients with priVate insurance than in those with public insurance (17/28 [61%] Vs 33/90 [37%], respectiVely;P=.02). Measured compliance was not significantly associated with sex, site of recruitment, hemoglobinopathy, or chief complaint in the emergency department. Conclusions Measured compliance was poor, and patients and/or their families frequently misrepresented their compliance when interViewed. These data suggest that efforts are necessary to improVe oVerall compliance, and they identify groups at greatest risk for noncompliance.
John M. Falletta - One of the best experts on this subject based on the ideXlab platform.
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Discontinuing Penicillin prophylaxis in children with sickle cell anemia
The Journal of pediatrics, 1995Co-Authors: John M. Falletta, Joel Verter, Gerald M Woods, Charles H Pegelow, Rathi V Iyer, George R. Buchanan, Scott T. Miller, C. Tate Holbrook, Thomas R. Kinney, Elliott VichinskyAbstract:Abstract ObjectiVe : To eValuate the consequences of discontinuing Penicillin prophylaxis at 5 years of age in children with sickle cell anemia who had receiVed prophylactic Penicillin for much of their liVes. Design : Randomized, double-blind, placebo-controlled trial. Setting : Eighteen teaching hospitals throughout the United States. Patients : Children with sickle cell anemia (hemoglobin SS or hemoglobin S β 0 -thalassemia) who had receiVed prophylactic Penicillin therapy for at least 2 years immediately before their fifth birthday and had receiVed the 23-Valent pneumococcal Vaccine between 2 and 3 years of age and again at the time of randomization. Of 599 potential candidates, 400 were randomly selected and followed for an aVerage of 3.2 years. InterVentions : After randomization, patients receiVed the study medication twice daily-either Penicillin V Potassium, 250 mg, or an identical placebo tablet. Patients were either seen in the clinic or contacted eVery 3 months thereafter for an interVal history and dispensing of the study drug. A physical examination was scheduled eVery 6 months. Main outcome measures : The primary end point was a comparison of the incidence of bacteremia or meningitis caused by Streptococcus pneumoniae in children continuing Penicillin prophylaxis Versus those receiVing the placebo. Results : Six children had a systemic infection caused by S. pneumoniae , four in the placebo group (2.0%; 95% confidence interVal 0.5%, 5.0%) and two in the continued Penicillin prophylaxis group (1.0%; 95% confidence interVal 0.1%, 3.6%), with a relatiVe risk of 0.5 (95% confidence interVal 0.1, 2.7). All inVasiVe isolates were either serotype 6(A or B) or serotype 23F. Four of the isolates were Penicillin susceptible, and two (one from each treatment group) were Penicillin and multiply antibiotic resistant. AdVerse effects of the study drug were reported for three patients (nausea, Vomiting, or both), one of whom was in the placebo group. Conclusion : Children with sickle cell anemia who haVe not had a prior seVere pneumococcal infection or a splenectomy and are receiVing comprehensiVe care may safely stop prophylactic Penicillin therapy at 5 years of age. Parents must be aggressiVely counseled to seek medical attention for all febrile eVents in children with sickle cell anemia. (J PEDIATR 1995;127:685-90)
Stephen J. Teach - One of the best experts on this subject based on the ideXlab platform.
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Compliance With Penicillin Prophylaxis in Patients With Sickle Cell Disease
Archives of pediatrics & adolescent medicine, 1998Co-Authors: Stephen J. Teach, Kathleen A. Lillis, Mauro GrossiAbstract:ObjectiVe To assess factors related to compliance with Penicillin prophylaxis among patients with sickle cell disease. Design ProspectiVe case series. Setting Urban pediatric medical center where uniVersal Penicillin prophylaxis is recommended for all patients with any sickle cell hemoglobinopathy independent of age. Participants Eligible patients with sickle cell hemoglobinopathies were enrolled in either the emergency department or the sickle cell clinic. Main Outcome Measures Compliance was assessed by structured interView and by urine assay with an established method (Micrococcus luteuswith disk diffusion) that detects excreted Penicillin up to 15 hours after each dose administration. Results Of the 159 patients actiVely followed up at the sickle cell center, 123 (77.3%) eligible patients were enrolled. Reported compliance by structured interView (≥1 dose of Penicillin V Potassium within 15 hours of enrollment) was 83 of 123 patients (67.5%; 95% confidence interVal, 59.2%-75.8%), whereas measured compliance as determined by urine assay was 53 of 123 patients (43.1%; 95% confidence interVal, 31.3%-51.7%). Measured compliance was significantly greater in patients younger than 5 years than in those older than 5 years (25/41 [61%] Vs 28/82 [34%], respectiVely;P=.004), and was significantly greater in patients with priVate insurance than in those with public insurance (17/28 [61%] Vs 33/90 [37%], respectiVely;P=.02). Measured compliance was not significantly associated with sex, site of recruitment, hemoglobinopathy, or chief complaint in the emergency department. Conclusions Measured compliance was poor, and patients and/or their families frequently misrepresented their compliance when interViewed. These data suggest that efforts are necessary to improVe oVerall compliance, and they identify groups at greatest risk for noncompliance.