cefdinir and Acute-Disease

Acute otitis media (AOM) is the inflammation of the middle ear. It constitutes one of the most frequent infections which affects children and usually occurs between 6 to 24 months of age. AOM can emerge due to viruses and/or bacteria. The aim of the current systematic review is to assess in children between 6 months and 12 years of age with AOM, the efficacy of any antimicrobial agent or placebo compared with amoxicillinclavulanate, to measure the resolution of AOM or symptoms.. The medical databases PubMed (MEDLINE) and Web of Science were used. Data extraction and analysis were performed by two independent reviewers. Eligibility criteria were set, and only randomised control trials (RCTs) were included. Critical appraisal of the eligible studies was performed. Pooled analysis was conducted using the Review Manager v. 5.4.1 software (RevMan).. Twelve RCTs were totally included. Three (25.0%) RCTs studied the impact of azithromycin, two (16.7%) investigated the impact of cefdinir, two (16.7%) investigated placebo, three (25.0%) studied quinolones, one (8.3%) investigated cefaclor and one (8.3%) studied penicillin V, compared to amoxicillin-clavulanate. In five (41.7%) RCTs, amoxicillin-clavulanate proved to be superior to azithromycin, cefdinir, placebo, cefaclor and penicillin V, while in seven (58.3%) RCTs its efficacy was comparable with other antimicrobials or placebo. The rates of AOM relapse after treatment with amoxicillin-clavulanate were comparable to those of other antimicrobials or placebo. However, amoxicillin-clavulanate was more effective in eradicating Streptococcus pneumoniae from the culture, when compared to cefdinir. The results of the meta-analysis were not evaluated due to substantial heterogeneity between studies.. Amoxicillin-clavulanate should be the treatment of choice for children between 6 months and 12 years of age with AOM.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Infective Agents; Azithromycin; Cefaclor; Cefdinir; Child; Humans; Infant; Otitis Media; Penicillin V; Treatment Outcome

Acute bacterial rhinosinusitis is a common infection resulting in substantial morbidity. Cefdinir, an oral cephalosporin, has extended-spectrum, bactericidal activity against common acute bacterial rhinosinusitis pathogens, including Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis. Cefdinir shows rapid oral absorption and good respiratory tissue penetration, and may be administered once daily. In randomised clinical trials, cefdinir showed efficacy similar to that of other recommended regimens in the treatment of acute bacterial rhinosinusitis, namely amoxicillin/clavulanate and levofloxacin. Cefdinir is well tolerated and has shown a low propensity to suppress the normal commensal flora. Cefdinir oral suspension is rated highly by children in terms of its taste and smell. As the only once-daily beta-lactam currently recommended by acute bacterial rhinosinusitis guidelines (for first-line use in patients with mild acute bacterial rhinosinusitis and no recent antibacterial use), cefdinir offers a convenient and attractive treatment option.

Topics: Acute Disease; Administration, Oral; Anti-Infective Agents; Cefdinir; Cephalosporins; Drug Administration Schedule; Haemophilus Infections; Haemophilus influenzae; Humans; Moraxella catarrhalis; Moraxellaceae Infections; Pneumococcal Infections; Randomized Controlled Trials as Topic; Sinusitis; Streptococcus pneumoniae

Topics: Acute Disease; Administration, Oral; Cefdinir; Cephalosporins; Child; Child, Preschool; Humans; Infant; Otitis Media; Pharyngitis; Streptococcal Infections; Streptococcus pyogenes

Previous studies suggest that the unexplained sudden and severe onset of obsessive-compulsive disorder (OCD) and/or tics may be infection or immune precipitated. Beta lactam antibiotics may be neuroprotective beyond their antimicrobial efficacy. We examine the preliminary safety and efficacy of cefdinir in reducing obsessive-compulsive and/or tic severity in children with new-onset symptoms.. Twenty subjects were randomized to receive placebo or cefdinir for 30 days for the treatment of recent-onset OCD and/or tics. The placebo group received a comparable inactive treatment matched for taste, color, and consistency. The Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) and Yale Global Tic Severity Scale (YGTSS) were the primary outcome measures utilized.. Subjects receiving cefdinir saw notable improvements in tic symptoms, with 44.4% showing at least a 25% reduction in YGTSS (mean decrease=9.5) scores compared with 9.1% of the placebo group (mean decrease=0.13). Despite improvements, significant group differences were not observed for YGTSS (F [1, 13]=4.03, p=0.066) although there were moderate differences between group treatment effects (d=0.72). For OCD symptoms, subjects receiving cefdinir saw improvements in OCD symptoms, with 33.3% showing at least a 25% reduction in CY-BOCS scores (mean decrease=7.8) compared with 27.3% of the placebo group (mean decrease=4.7), but there were also no significant differences for CY-BOCS (F [1, 13]=0.385, p=0.546; d=0.24).. Subjects assigned to cefdinir exhibited notable, albeit nonstatistically significant, improvements in tic symptoms, compared with the placebo group. There were also some improvements in OCD symptoms, although these were not significant. Overall, cefdinir was well tolerated. Given these preliminary results, a fully powered study is warranted to explore the efficacy of cefdinir as a therapeutic tool for new-onset pediatric neuropsychiatric symptoms, particularly those that appear to be precipitated by infection.

Topics: Acute Disease; Adolescent; Anti-Bacterial Agents; Cefdinir; Cephalosporins; Child; Child, Preschool; Female; Humans; Male; Obsessive-Compulsive Disorder; Pilot Projects; Tic Disorders

Severe acute malnutrition contributes to 1 million deaths among children annually. Adding routine antibiotic agents to nutritional therapy may increase recovery rates and decrease mortality among children with severe acute malnutrition treated in the community.. In this randomized, double-blind, placebo-controlled trial, we randomly assigned Malawian children, 6 to 59 months of age, with severe acute malnutrition to receive amoxicillin, cefdinir, or placebo for 7 days in addition to ready-to-use therapeutic food for the outpatient treatment of uncomplicated severe acute malnutrition. The primary outcomes were the rate of nutritional recovery and the mortality rate.. A total of 2767 children with severe acute malnutrition were enrolled. In the amoxicillin, cefdinir, and placebo groups, 88.7%, 90.9%, and 85.1% of the children recovered, respectively (relative risk of treatment failure with placebo vs. amoxicillin, 1.32; 95% confidence interval [CI], 1.04 to 1.68; relative risk with placebo vs. cefdinir, 1.64; 95% CI, 1.27 to 2.11). The mortality rates for the three groups were 4.8%, 4.1%, and 7.4%, respectively (relative risk of death with placebo vs. amoxicillin, 1.55; 95% CI, 1.07 to 2.24; relative risk with placebo vs. cefdinir, 1.80; 95% CI, 1.22 to 2.64). Among children who recovered, the rate of weight gain was increased among those who received antibiotics. No interaction between type of severe acute malnutrition and intervention group was observed for either the rate of nutritional recovery or the mortality rate.. The addition of antibiotics to therapeutic regimens for uncomplicated severe acute malnutrition was associated with a significant improvement in recovery and mortality rates. (Funded by the Hickey Family Foundation and others; ClinicalTrials.gov number, NCT01000298.).

Topics: Acute Disease; Amoxicillin; Anti-Bacterial Agents; Cefdinir; Cephalosporins; Child, Preschool; Combined Modality Therapy; Double-Blind Method; Female; Humans; Infant; Kaplan-Meier Estimate; Male; Protein-Energy Malnutrition; Risk; Treatment Outcome; Weight Gain

10 days of amoxicillin/clavulanic acid high dose and 5 days of cefdinir have been the preferred first- or second-line antibiotics for treatment of children with acute otitis media (AOM) since 2004, as recommended by the American Academy of Pediatrics in the USA, but no head-to-head comparison study has been done.. The purpose of the study was to compare the clinical efficacy of amoxicillin/clavulanic acid high-dose therapy for 10 days with cefdinir therapy for 5 days for AOM at recommended doses.. This was an investigator-blind trial in young children 6-24 months old with no history of recurrent AOM who were randomly assigned to amoxicillin/clavulanic acid (80 mg/kg/day amoxicillin) or cefdinir (14 mg/kg/day), both in two divided doses. The diagnosis of AOM was based on specific clinical criteria by validated otoscopists at two AOM research centres. The outcome measure for clinical cure was resolution of all symptoms and signs of AOM except for persistence of middle-ear effusion at test-of-cure (TOC) 11-14 days after initiation of antibiotic treatment. Clinical failure was defined as persistence of symptoms and signs of AOM and the need for additional antibiotic therapy. Subjects lost to follow up or who had not taken at least 80% of the prescribed medication were classified as having an indeterminate response. Compliance was monitored using Medical Electronic Monitoring System (MEMS) caps and antibiotic bottle volume measurement at the TOC visit. A logistic regression model was used to estimate the association of age with cure rate. Full interactions in terms of age with treatment were included to estimate any age gradient differential.. A total of 330 children (average age 13.1 months) with AOM were studied. At TOC, 256 children had clinical cure, 69 had clinical failure, and 5 were lost to follow-up. High-dose amoxicillin/clavulanic acid-treated children had a better cure rate (86.5%) than cefdinir-treated patients (71.0%; p = 0.001). Cefdinir was correlated with less frequent cure outcomes as children increased in age between 6 and 24 months. The odds ratios for clinical cure per increasing month of age estimated from a logistic regression model for amoxicillin/clavulanic acid high dose and cefdinir treatment groups was 0.992 (95% CI 0.932, 1.056), p > 0.05 and 0.932 (95% CI 0.881, 0.986), p = 0.01. The differences in the odds ratios are significant at p < 0.002, indicating a stable clinical cure rate across the ages of children studied for amoxicillin/clavulanic acid and decreasing clinical cure rates as children increased in age for cefdinir.. In children with bona fide AOM for whom clinical outcomes are assessed by validated otoscopists, 10 days of high-dose amoxicillin/clavulanic acid is significantly more effective than 5 days of cefdinir as therapy for AOM. Because of the identified age effect (correlated to child weight), higher doses of cefdinir may have led to a different conclusion; 10 days of cefdinir may also have led to a different conclusion.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefdinir; Cephalosporins; Drug Administration Schedule; Follow-Up Studies; Humans; Infant; Otitis Media; Prospective Studies; Single-Blind Method; Treatment Outcome

Of several oral cephalosporins, cefdinir is recommended as an alternative therapy for children with acute otitis media who have type 1 hypersensitivity to beta-lactams. Because the current cefdinir dosage of 14 mg/kg/d is approved for treatment of acute otitis media caused by penicillin-susceptible Streptococcus pneumoniae, we hypothesized that a 25-mg/kg dose given daily would be more effective for nonsusceptible S. pneumoniae.. We performed pharmacokinetic analyses on 37 infants and children who were given cefdinir in dosages of 14 or 25 mg/kg once daily for 10 days, for the treatment of respiratory and skin or skin structure infections. Cefdinir plasma concentrations were determined with validated liquid chromatology, and pharmacokinetics and pharmacodynamics were determined in relation to the minimum inhibitory concentration values of S. pneumoniae.. The maximal plasma concentrations and area-under-the-curve values were significantly higher after the 25-mg/kg in relation to the minimum inhibitory concentration values for S. pneumoniae strains. The pharmacodynamics measure of bacteriologic effectiveness was <40% of the dosing interval (ie, 24 hours), indicating that many of the penicillin-nonsusceptible S. pneumoniae causing acute otitis media would not be effectively treated. Diarrhea occurred in 20% of the 39 subjects that received the larger dosage of cefdinir.. A cefdinir dosage of 25 mg/kg daily would be ineffective for treatment of acute otitis media caused by penicillin-nonsusceptible S. pneumoniae strain.

Topics: Acute Disease; Anti-Infective Agents; Cefdinir; Cephalosporins; Child; Child, Preschool; Humans; Infant; Microbial Sensitivity Tests; Otitis Media; Penicillin Resistance; Pneumococcal Infections; Respiratory Tract Infections; Soft Tissue Infections; Streptococcus pneumoniae; Treatment Outcome

Given the relatively high prevalence of recurrent and persistent acute otitis media (AOM) and the prominent etiologic role of Streptococcus pneumoniae, especially penicillin-nonsusceptible strains in children with these conditions, new alternative treatments are desirable.. Children 6 months-4 years of age with AOM considered to be at risk for recurrent or persistent infection received large dosage cefdinir 25 mg/kg oral suspension once daily for 10 days. Children were evaluated pretreatment (day 1), on therapy (days 4-6), end of therapy (days 12-14) and at follow-up (days 25-28). All children had tympanocentesis at enrollment. In culture-positive children, tympanocentesis was repeated after 3-5 days (days 4-6) unless evidence of absence of middle ear effusion was documented.. Of 447 children enrolled, 230 were clinically and bacteriologically evaluable (74% 2 years old or younger; 57% treated for AOM in previous 3 months). Bacteriologic eradication, based on repeat tympanocentesis on days 4-6, was achieved in 74% (170 of 230) of children; 76% (201 of 266) of AOM pathogens were eradicated. Eradication of penicillin-susceptible, -intermediate and -resistant S. pneumoniae was 91% (50 of 55), 67% (18 of 27) and 43% (10 of 23), respectively (P < 0.001); eradication of H. influenzae was 72% (90 of 125). Overall clinical response at days 12-14 was 83% (76 and 82% for children with S. pneumoniae and Haemophilus influenzae, respectively). Sustained clinical response at days 25-28 was 85%. Clinical response was 83% for culture-positive children versus 96% for culture-negative children at baseline tympanocentesis (P < 0.001).. In this study of AOM among children at risk for persistent or recurrent infection, large dose cefdinir resulted in an overall successful clinical response at end of treatment of 83%. This regimen was efficacious against penicillin-susceptible S. pneumoniae, but effectiveness was markedly decreased against nonsusceptible strains and was moderate for H. influenzae strains.

Topics: Acute Disease; Administration, Oral; Anti-Infective Agents; Cefdinir; Cephalosporins; Child, Preschool; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Otitis Media with Effusion; Paracentesis; Penicillin Resistance; Pneumococcal Infections; Recurrence; Risk Factors; Streptococcus pneumoniae; Treatment Outcome

To compare efficacy, tolerability, and parental satisfaction of cefdinir and high-dose amoxicillin/clavulanate oral suspensions given to young children with non-refractory acute otitis media (AOM) based on clinical endpoints and outcomes measures.. This was an investigator-blinded, multicenter study in which 318 children 6 months through 6 years of age with a clinical diagnosis of AOM were randomized to receive 10 days of either cefdinir (14 mg/kg divided BID) or high-dose amoxicillin/clavulanate (90/6.4 mg/kg divided BID).. Investigators evaluated clinical response at an end-of-therapy (EOT) office visit conducted on day 12-15. Outcomes of satisfaction, tolerability, and adherence were also assessed at that visit using an Otitis Parent Questionnaire.. The treatment groups were similar at baseline with respect to patient demographics. At the EOT visit, for cefdinir and amoxicillin/clavulanate, respectively, intent-to-treat (ITT) clinical cure rates were 82% (129/158) and 85% (134/158) (p = 0.547; 95% confidence interval [CI] -11.7 to 5.4) and per-protocol cure rates were 82% (123/150) and 90% (129/143) (p = 0.045; 95% CI -16.4 to 0.0). This difference was driven primarily by reduced cefdinir response in patients with recurrent AOM (p = 0.010) and those younger than 24 months (p = 0.039). Comparing cefdinir with amoxicillin/clavulanate, parents more often reported significantly better ease of use (89% vs. 57%; p < 0.0001), better taste (85% vs. 39%; p < 0.0001), and better adherence (at least 95% of doses) (82% vs. 61%; p < 0.0001). Diarrhea/loose stools were more common in the amoxicillin/clavulanate group than in the cefdinir group (28% vs. 18%, respectively; p = 0.0341). One patient in the cefdinir group and eight patients in the amoxicillin/clavulanate group withdrew from the study prematurely due to at least one adverse event (p = 0.0364). Study limitations included assessment of clinical recurrence by telephone call rather than office visit, exclusion of children with refractory AOM, and no assessment of middle ear microbiology.. Among young children with non-refractory AOM, cefdinir was as efficacious as high-dose amoxicillin/clavulanate in the ITT group, but somewhat less effective in per-protocol analysis. From the parental perspective, cefdinir was easier to administer, had a better taste, caused less diarrhea, and resulted in higher treatment adherence than high-dose amoxicillin clavulanate.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Cefdinir; Cephalosporins; Child; Child, Preschool; Dose-Response Relationship, Drug; Female; Humans; Infant; Male; Otitis Media; Parents; Prospective Studies; Treatment Outcome

The effect on the nasopharyngeal bacterial flora of 10 days of amoxycillin-clavulanate or cefdinir antimicrobial therapy was studied in 50 children with acute otitis media. Before therapy, 17 potential pathogens (Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis) were isolated from the nasopharynx of 14 (56%) of those treated with amoxycillin-clavulanate, and 20 potential pathogens were recovered from 15 (60%) of those treated with cefdinir. Following therapy, at days 12-15, the number of potential pathogens was reduced to a similar extent with both therapies, to three in those treated with amoxycillin-clavulanate and two in those treated with cefdinir. However, the number of potential pathogens rebounded faster in those treated with amoxycillin-clavulanate as compared with cefdinir in the two subsequent specimens taken at days 30-35 and 60-65 (12 and 18 in the amoxycillin-clavulanate group, and six and nine in the cefdinir group, P < 0.01 and P < 0.001, respectively). Differences between the groups were also noted in the recovery of organisms with interfering capability. Immediately following amoxycillin-clavulanate therapy, the number of interfering organisms declined from 54 to 13, while following cefdinir treatment their number was reduced from 59 to 39 (P < 0.001). The differences between the two therapy groups persisted in the two later specimens taken at days 30-35 and 60-65 (25 and 38 in the amoxycillin-clavulanate group, and 52 and 51 in the cefdinir group, P < 0.001 and P < 0.05, respectively). This study illustrates the potential beneficial effect of using a narrow-spectrum antimicrobial that selectively spares the interfering organisms while eliminating pathogens. The benefit of such therapy is the prevention of reacquisition of pathogenic bacteria in the nasopharynx. In contrast, utilization of a broad-spectrum antimicrobial is associated with prolonged absence of inhibitory organisms and rapid recolonization with pathogens.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefdinir; Cephalosporins; Child; Colony Count, Microbial; Haemophilus influenzae; Humans; Moraxella catarrhalis; Nasopharynx; Otitis Media; Streptococcus pneumoniae; Time Factors

Short-course therapy for acute otitis media (AOM) improves adherence and may reduce secondary bacterial resistance.. In this multicenter, prospective, investigator-blinded study, patients between the ages of 6 months and 6 years with a clinical diagnosis of AOM were randomized to receive cefdinir oral suspension 7 mg/kg q12h for 5 days or azithromycin oral suspension 10 mg/kg once daily on day 1 and 5 mg/kg once daily on days 2 through 5. Clinical response was assessed at the end-of-therapy (EOT) visit (days 7-9) and the follow-up visit (days 20-25).. Three hundred fifty-seven patients were enrolled in the study. The treatment groups were similar at baseline with respect to demographic characteristics (mean [SD] age, 3.0 [1.7] years; 55% male), incidence of bilateral AOM (45%), and presenting signs and symptoms. The majority of evaluable children (77%) had previously received conjugated heptavalent pneumococcal vaccine (PCV7) against Streptococcus pneumoniae. At the EOT visit, clinical cure rates were comparable for cefdinir and azithromycin (87% [151/174] and 85% [149/176], respectively; 95% CI, -5.5 to 9.8). In addition, clinical cure rates at the EOT visit in the children who had been vaccinated with PCV7 were comparable between cefdinir and azithromycin (86% vs 83%; 95% CI, -6.5 to 11.8). No significant difference in clinical cure rates was observed at the follow-up visit (76% and 86%; 95% CI, -18.9 to 0.0). Parental satisfaction was similar between treatment groups with regard to ease of use, taste, compliance, health care resource utilization, and missed days of work and day-care. Both antibiotics were well tolerated; diarrhea and abnormal stools were the most common antibiotic-related adverse events (< or = 7% each).. Short courses (5 days) of therapy with cefdinir or azithromycin were comparable in these children with AOM based on clinical end points, parental preferences, and health care utilization.

Topics: Acoustic Impedance Tests; Acute Disease; Administration, Oral; Analgesics; Analgesics, Non-Narcotic; Anti-Infective Agents; Anti-Inflammatory Agents; Azithromycin; Cefdinir; Cephalosporins; Child, Preschool; Diarrhea; Drug Administration Schedule; Female; Heptavalent Pneumococcal Conjugate Vaccine; Humans; Male; Meningococcal Vaccines; Otitis Media; Pneumococcal Vaccines; Prospective Studies; Single-Blind Method; Streptococcus pneumoniae; Time Factors; Treatment Outcome; Tympanic Membrane

Short course beta-lactam antibiotic therapy for acute otitis media (AOM) should improve patient adherence, but it has not been evaluated since the heptavalent pneumococcal conjugate vaccine became routinely used in the United States.. In a prospective, investigator-blinded, multicenter study, 425 patients, age 6 months-6 years, with a clinical diagnosis of nonrefractory AOM were randomized to receive either 5 days of cefdinir therapy (14 mg/kg divided twice daily) or 10 days of amoxicillin/clavulanate therapy (45/6.4 mg/kg divided twice daily). Clinical response was assessed at end of therapy (2-4 days postantibiotic, respectively) and week 4 (study days 25-28).. With no difference in demographics between treatment groups, overall the mean age (+/-SD) was 2.8 +/- 1.8 years, 65% had received conjugated pneumococcal vaccination and 48% had bilateral AOM. The satisfactory clinical response rate at end of therapy was comparable for cefdinir versus amoxicillin/clavulanate (88%, 170 of 194 versus 85%, 164 of 192; 95% CI -4.9, 9.3). Although this must be interpreted with caution, cefdinir showed an apparent trend for higher efficacy than amoxicillin/clavulanate (92%, 72 of 78 versus 77%, 55 of 71; P = 0.019) in a subsample of patients 6-24 months old who had received conjugated pneumococcal vaccination. The incidence of drug-related adverse events was less for cefdinir than for amoxicillin/clavulanate (24%, 50 of 211 versus 38%, 82 of 214; P = 0.0018). For children with nonrefractory AOM, based only on clinical endpoints, 5 days of therapy with cefdinir 14 mg/kg divided twice daily was comparable overall with 10 days of therapy with low dose amoxicillin/clavulanate 45/6.4 mg/kg divided twice daily.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Cefdinir; Cephalosporins; Child; Child, Preschool; Confidence Intervals; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media; Probability; Prospective Studies; Reference Values; Risk Assessment; Single-Blind Method; Treatment Outcome

Treatment guidelines for acute bacterial rhinosinusitis (ABRS) recommend 10 to 14 days of therapy with high-dose amoxicillin, amoxicillin/clavulanate, cefdinir, cefpodoxime, cefuroxime, a macrolide, or a newer fluoroquinolone, among other agents.. This study compared the clinical efficacy and tolerability of cefdinir and levofloxacin in patients with a diagnosis of acute rhinosinusitis of presumed bacterial origin.. In this multicenter, double-blind, noninferiority study, ambulatory adult patients who had signs and symptoms for >7 to 21 days before the screening visit and radiographic findings consistent with acute rhinosinusitis were randomized to receive cefdinir 600 mg or levofloxacin 500 mg, each once daily for 10 days. Clinical and radiologic response rates were determined at the test-of-cure (TOC) visit, which took place 9 to 14 days after the completion of treatment.. Two hundred seventy-one patients (138 cefdinir, 133 levofloxacin) were enrolled and randomized to treatment at 27 study centers in the United States and Poland between November 2003 and March 2004. Of these, 241 (123 cefdinir, 118 levofloxacin) were clinically evaluable. The cefdinir group consisted of 75 women and 48 men, of whom 117 were white and 6 black; their mean (SD) age was 42.5 (14.3) years. The levofloxacin group consisted of 71 women and 47 men, of whom 111 were white and 7 black; their mean age was 40.4 (13.6) years. The 2 groups were similar in terms of presenting signs and symptoms and baseline radiographic findings. The most common presenting symptoms were sinus pain, sinus pressure, and purulent nasal discharge, each of which was reported by > or =89% of patients. Clinical cure rates at the TOC visit in the cefdinir and levofloxacin groups were 83% (102/123) and 86% (101/118), respectively (95% Cl for the difference in cure rates, -12.3 to 7.0). Cefdinir and levofloxacin were comparable in the treatment of infections classified as moderate to severe. The incidence of drug-related adverse events was generally comparable in the 2 treatment groups, although there were significant differences between cefdinir and levofloxacin in the incidence of vaginal moniliasis in women (11% vs 0%, respectively; P = 0.003), drug-related diarrhea (8% vs 1%; P = 0.005), and insomnia (0% vs 4%; P = 0.027). Only 2% of patients discontinued therapy prematurely as a result of a drug-related adverse event.. In this population of patients with ABRS, the extended-spectrum cephalosporin cefdinir was as efficacious as the fluoroquinolone levofloxacin, suggesting that cefdinir may be a suitable alternative to the currently recommended fluoroquinolones.

Topics: Acute Disease; Adult; Aged; Anti-Infective Agents; Cefdinir; Cephalosporins; Double-Blind Method; Female; Humans; Levofloxacin; Male; Middle Aged; Ofloxacin; Severity of Illness Index; Sinusitis; Treatment Outcome

Patients with acute exacerbations of chronic bronchitis were treated with cefdinir 300 mg bd for 5 days or cefprozil 500 mg bd for 10 days in a prospective, randomized, double-blind, multicentre study. Of the 548 patients enrolled, 281 (51%) were evaluable. The clinical cure rates at the test-of-cure visit were 80% (114/142) and 72% (100/139) for the evaluable patients treated with cefdinir and cefprozil, respectively. Respiratory tract pathogens were isolated from 409 (75%) of 548 admission sputum specimens, with the predominant pathogens being Haemophilus parainfluenzae, Haemophilus influenzae, Staphylococcus aureus and Moraxella catarrhalis. The microbiological eradication rates at the test-of-cure visit were 81% (157 of 193 pathogens) and 84% (166 of 198 pathogens) for the evaluable patients treated with cefdinir and cefprozil, respectively. Adverse event rates while on treatment were equivalent between the two treatment groups. The incidence of diarrhoea during therapy was higher for patients treated with cefdinir (17%) than for patients treated with cefprozil (6%) (P < 0.01), but most cases were mild and did not lead to discontinuation of treatment. These results indicate that a 5 day regimen of cefdinir is as effective and safe in the treatment of patients with acute exacerbations of chronic bronchitis as a 10 day regimen of cefprozil.

Topics: Acute Disease; Adolescent; Adult; Aged; Anti-Infective Agents; Bronchitis; Cefdinir; Cefprozil; Cephalosporins; Child; Chronic Disease; Double-Blind Method; Female; Humans; Male; Middle Aged; Patient Compliance; Pharyngitis; Prospective Studies; Tonsillitis

To compare the clinical efficacy of a 5-day cefdinir course with a 10-day cefprozil course in the treatment of pediatric acute otitis media (AOM).. Comparative, investigator-blinded multicenter trial.. Primary care, ambulatory.. Children ages 6 months through 12 years with clinical symptoms and tympanic membrane signs of AOM, plus tympanometric-confirmed middle ear effusion in at least 1 ear. Of the 435 patients enrolled in the study, 373 were evaluable.. Patients received cefdinir 14 mg/ kg/day divided twice a day for 5 days or cefprozil 30 mg/kg/day divided twice a day for 10 days.. Clinical resolution of tympanic membrane signs and symptoms of AOM determined at end of therapy on Study Days 9 to 11.. The clinical cure rate at end of therapy was 80% (152 of 190) for cefdinir-treated patients and 82.5% (151 of 183) for cefprozil-treated patients (95% confidence interval, 10.43% to 5.4%). Diarrhea and overall adverse reactions, respectively, occurred in 7.8 and 13% of cefdinir-treated patients and in 4.2 and 12% of cefprozil-treated patients.. A short course 5-day regimen of cefdinir was as clinically effective and well-tolerated as a 10-day regimen of cefprozil in the treatment of nonrefractory AOM.

Topics: Acute Disease; Cefdinir; Cefprozil; Cephalosporins; Child; Child, Preschool; Female; Humans; Infant; Male; Otitis Media; Treatment Outcome

To examine the microbiologic and clinical efficacy of a 5-day course of cefdinir in the treatment of tympanocentesis-documented acute otitis media (AOM).. Open label noncomparative trial.. Primary care, ambulatory.. Children ages 6 months through 12 years with signs of AOM and middle ear effusion confirmed by tympanometry in at least one ear.. Patients underwent tympanocentesis at baseline and received cefdinir 7 mg/kg twice a day for 5 days.. Presumptive eradication of middle ear pathogens determined by clinical cure of signs and symptoms of AOM at end of therapy (Study Days 7 to 9) and Visit 3 (Study Days 16 to 21).. A total of 125 of 177 enrolled children had 134 pathogens isolated by tympanocentesis: Streptococcus pneumoniae, 69 (51.5%); Haemophilus influenzae 44 (32.8%; beta-lactamase-positive in 18 of 44 strains); beta-lactamase-positive Moraxella catarrhalis, 15 (11.2%); and Streptococcus pyogenes, 6 (4.5%). The clinical cure rates by patient in the microbiologically and overall clinically evaluable groups, respectively, were 73% (84 of 115) and 77.4% (130 of 168) at the end of therapy visit and 57.4% (66 of 115) and 61.9% (104 of 168) at Visit 3. Presumptive eradication rates at end of therapy were 8 of 11 (72.7%) and 4 of 8 (50%) for patients with penicillin-intermediate and -resistant S. pneumoniae isolates, respectively. Adverse reactions occurred in 16% of patients, with diarrhea (11%) occurring most frequently.. A 5-day regimen of cefdinir was effective in the eradication of the common causative pathogens of nonrefractory AOM, including intermediate penicillin-resistant S. pneumoniae and beta-lactamase-producing organisms. Cefdinir should be considered a suitable second line antibiotic for AOM.

Topics: Acoustic Impedance Tests; Acute Disease; Bacterial Infections; Cefdinir; Cephalosporins; Child; Child, Preschool; Female; Haemophilus influenzae; Humans; Infant; Male; Microbial Sensitivity Tests; Moraxella catarrhalis; Otitis Media; Otitis Media with Effusion; Penicillin Resistance; Streptococcus pneumoniae; Streptococcus pyogenes; Treatment Outcome

Two dosage regimens of cefdinir were compared with amoxicillin/clavulanate for the treatment of suppurative acute otitis media (AOM) in children.. This was an investigator-blinded, randomized, comparative, multicenter trial, in which tympanocentesis was performed in 384 patients, ages 6 months to 12 years, who had nonrefractory AOM. Patients were randomized to receive one of three 10-day treatment regimens: cefdinir 14 mg/kg daily (QD; n = 128); cefdinir 7 mg/kg twice a day (BID; n = 128); or amoxicillin/clavulanate 40/10 mg/kg/day divided for use three times a day (TID; n = 128).. Of the 384 enrolled patients 303 were evaluable for clinical efficacy. Clinical success rates were statistically equivalent for the 3 treatment groups at the end of therapy: 85 of 102 (83.3%) for cefdinir QD; 81 of 101 (80.2%) for cefdinir BID; 86 of 100 (86%) for amoxicillin/clavulanate. Of the 197 evaluable patients from whom a susceptible pathogen was recovered, presumptive eradication rates at end of therapy were equivalent: 55 of 65 (84.6%), 54 of 66 (81.8%) and 55 of 66 (83.3%) for cefdinir QD-, cefdinir BID- and amoxicillin/clavulanate-treated patients, respectively. However, presumptive eradication rates for Streptococcus pneumoniae were significantly lower for cefdinir BID (55.2%) than for amoxicillin/clavulanate (89.5%; P = 0.0019) and marginally lower than for cefdinir QD (80%; P = 0.054). Diarrhea was the most common treatment-associated adverse reaction in all groups but was significantly more common in amoxicillin/clavulanate-treated patients (35%) than in patients who had been treated with cefdinir QD (10%, P<0.001) or cefdinir BID (13%, P<0.001).. A 10-day regimen of cefdinir 14 mg/kg QD or 7 mg/kg BID was as clinically effective overall as a 10-day regimen of amoxicillin/ clavulanate 40/10 mg/kg/day divided TID in the treatment of tympanocentesis-confirmed, nonrefractory AOM in children. These data suggest that cefdinir QD may be a better alternative than cefdinir BID for refractory AOM. Both dosing regimens of cefdinir were associated with significantly fewer gastrointestinal adverse reactions than was amoxicillin/clavulanate.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Cefdinir; Cephalosporins; Child; Child, Preschool; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media, Suppurative; Treatment Outcome

An investigator-blinded, randomized, multicenter study was conducted to compare the efficacy and safety of cefdinir and amoxicillin/ clavulanate (amoxicillin/CA) in the treatment of pediatric patients with acute suppurative otitis media. Patients 6 months to 12 years of age were randomized in a 1:1:1 ratio to receive cefdinir 14 mg/kg once-daily, cefdinir 7 mg/kg b.i.d., or amoxicillin/CA 13.3 mg/kg t.i.d. Test-of-cure was determined 11 to 16 days posttherapy. Of the 752 patients who entered the study, 665 (88%) completed treatment and 595 (79%) were evaluable. Response rates in the three treatment groups were similar. Overall rates of adverse events were statistically lower in the cefdinir once-daily group than in the amoxicillin/CA group. Diarrhea was the most common adverse event in all treatment groups. Cefdinir given either once-daily or twice-daily is a safe and effective treatment for pediatric patients with acute suppurative otitis media.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Cefdinir; Cephalosporins; Child; Child, Preschool; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media, Suppurative; Treatment Outcome

Acute otitis media (AOM) is a common indication for antibiotics in children. We sought to characterize the frequency of nonguideline concordant antibiotic therapy for AOM in the United States, by agent and duration.. Using national administrative claims data (2016-2019), we identified children aged 6 months to 17 years with an oral antibiotic dispensed within 3 days of a new diagnosis of suppurative AOM. Use of nonguideline concordant agents and durations, defined based on national treatment guidelines, were summarized by age, race, rurality, region, and insurance type. Subsequent oral antibiotic dispensing within the year after AOM diagnosis was also evaluated. We created sunburst diagrams to visualize longitudinal patterns of within-person antibiotic utilization for AOM, by agent and duration.. We identified 789 424 eligible commercially-insured and 502 239 medicaid-insured children. Among commercially insured children, 35% received nonguideline concordant agents for AOM, including cefdinir (16%), amoxicillin-clavulanate (12%), and azithromycin (7%). Fewer children age <2 years received a nonguideline concordant initial agent (27%) compared to age ≥6 years (41%). More children age <2 years received three or more antibiotics over the following year (34% vs. 3% for children age ≥6 years). The most common treatment duration was 10 days for all ages; treatment duration for the initial antibiotic was nonguideline concordant for 95% and 89% of children age 2-5 years and ≥6 years, respectively. Patterns were similar for medicaid-insured children.. Nonguideline concordant antibiotic use is common when treating AOM in children, including use of broad-spectrum agents and longer-than-recommended antibiotic durations.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefdinir; Child; Humans; Infant; Otitis Media; United States

The objective of the study was to compare the antibiotic treatment failure and recurrence rates between antibiotic agents (amoxicillin, amoxicillin-clavulanate, cefdinir, and azithromycin) for children with uncomplicated acute otitis media (AOM).. We completed a retrospective cohort study of children 6 months-12 years of age with uncomplicated AOM identified in a nationwide claims database. The primary exposure was the antibiotic agent, and the primary outcomes were treatment failure and recurrence. Logistic regression was used to estimate ORs, and analyses were stratified by primary exposure, patient age, and antibiotic duration.. Among the 1 051 007 children included in the analysis, 56.6% were prescribed amoxicillin, 13.5% were prescribed amoxicillin-clavulanate, 20.6% were prescribed cefdinir, and 9.3% were prescribed azithromycin. Most prescriptions (93%) were for 10 days, and 98% were filled within 1 day of the medical encounter. Treatment failure and recurrence occurred in 2.2% (95% CI: 2.1, 2.2) and 3.3% (3.2, 3.3) of children, respectively. Combined failure and recurrence rates were low for all agents including amoxicillin (1.7%; 1.7, 1.8), amoxicillin-clavulanate (11.3%; 11.1, 11.5), cefdinir (10.0%; 9.8, 10.1), and azithromycin (9.8%; 9.6, 10.0).. Despite microbiologic changes in AOM etiology, treatment failure and recurrence were uncommon for all antibiotic agents and were lower for amoxicillin than for other agents. These findings support the continued use of amoxicillin as a first-line agent for AOM when antibiotics are prescribed.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Cefdinir; Child; Humans; Infant; Otitis Media; Retrospective Studies; Treatment Outcome

Topics: Acute Disease; Aged; Anti-Bacterial Agents; Antibodies, Monoclonal; Antirheumatic Agents; Arthritis, Rheumatoid; Cefdinir; Cephalosporins; Enterocolitis, Pseudomembranous; Fatal Outcome; Humans; Immunocompromised Host; Infliximab; Male; Rhinitis; Risk Assessment; Sinusitis

The antibacterial susceptibility to frequently prescribed antibiotics of Streptococcus pneumoniae isolated from the pediatric patients with acute respiratory infectious diseases was investigated in a study of three medical institutions in Korea. Total 143 clinical isolates of S. pneumoniae were available for susceptibility tests between May 2003 and July 2007. Antimicrobial susceptibility data for S. pneumoniae were analyzed by using agents of amoxicillin, cefaclor, cefuroxime, cefdinir, and cefditoren as the test antibiotics. The prevalence of each resistance class, penicillin-resistant S. pneumoniae (PRSP) were high with the proportion of MIC range (susceptible = 8.4%, intermediate resistance = 18.2%, resistance = 73.4%). MIC90 and susceptible (S) rate of antimicrobial agents to the strains tested were amoxicillin (MIC90 = 4 microg/ml, S = 76.2%), cefaclor (MIC90 = 128 microg/ml, S=8.4%), cefuroxime (MIC90 = 16 microg/ml, S = 24.5%), cefdinir (MIC90 = 16 microg/ml, S = 21.8%), and cefditoren (MIC90 = 0.5 microg/ml, S=90.2%) respectively. Against clinical isolates including PRSP, cefditoren demonstrated the strongest antibacterial activity intrinsically among the antibiotics tested. Conclusively, the antimicrobial activity of cefditoren to S. pneumoniae strains isolated from pediatric patients with acute respiratory infection is very high. In South Korea, where the antibiotic resistance ofS. pneumoniae is issued, cefditoren is expected to be used as a primary or secondary antibiotic. Moreover, cefditoren may serve as a useful option for secondary antibiotics after failure of amoxicillin treatment, which is most primarily used for acute respiratory S. pneumoniae infection in children.

Topics: Acute Disease; Amoxicillin; Anti-Bacterial Agents; Cefaclor; Cefdinir; Cefuroxime; Cephalosporins; Child; Child, Preschool; Community-Acquired Infections; Drug Resistance, Bacterial; Humans; Korea; Respiratory Tract Infections; Streptococcus pneumoniae

Cephalosporins were found to be more effective than penicillins in the eradication of group A beta-hemolytic streptococcal (GABHS) from tonsillar tissues. This study investigated the effect of amoxicillin and cefdinir therapies on the rate of eradication of GABHS from the tonsils of children with acute pharyngo-tonsillitis (PT).. Of 50 children suffering from PT 25 were treated with amoxicillin (40 mg/(kg d) or 250 mg every 8 h) and 25 with cefdinir (14 mg/(kg d) or 600 mg once a day) for 10 days. Pharyngo-tonsillar cultures were obtained from all children before treatment and on the 1st, 2nd, 3rd, 4th, 7th, and 12th days.. GABHS was eradicated more rapidly from children treated with cefdinir as compared to those receiving amoxicillin. A smaller number of patients with GABHS were found in those treated with cefdinir as compared to amoxicillin throughout the treatment period. Eradication of GABHS from 68% (8 of 25 patients) was noted in those treated with cefdinir after 2 days and those treated with amoxicillin after 4 days. The differences between the number of patients who had a bacteriological cure between those receiving cefdinir to those getting amoxicillin was statistical significant at day 4 (32% vs. 8%). At the end of therapy GABHS was recovered from 5 (20%) and 2 (8%) of the patients. The group that received cefdinir, had a more rapid reduction in fever on the first after initiation of therapy as compared to those receiving amoxicillin. The fever reduction in those receiving cefdinir occurred a day earlier than in those getting amoxicillin.. Fever was reduced and GABHS was eradicated more rapidly from children treated with cefdinir as compared to amoxicillin.

Topics: Acute Disease; Amoxicillin; Anti-Bacterial Agents; Cefdinir; Cephalosporins; Child; Child, Preschool; Comorbidity; Drug Therapy, Combination; Female; Fever; Hemolysis; Humans; Male; Pharyngitis; Streptococcal Infections; Streptococcus pyogenes; Time Factors; Tonsillitis

To compare the effects of cefdinir (14 mg/kg per day) and amoxicillin (90 mg/kg per day) antimicrobial therapy on the nasopharyngeal flora of children with acute otitis media.. Nasopharyngeal cultures for aerobic and facultative bacteria were obtained before therapy and 2 to 4 days after completion of therapy.. Outpatient clinic.. Fifty children, aged 7 months to 5 years 4 months.. After completion of therapy, 22 (88%) of the 25 patients treated with cefdinir and 16 (64%) of the 25 patients treated with amoxicillin were considered clinically cured (P<.05). A significant reduction in the number of all isolates occurred following therapy in those treated with cefdinir (36 vs 71, P<.01) or with amoxicillin (56 vs 73, P<.05). However, the total number of isolates recovered after therapy was significantly lower in those treated with cefdinir (36) compared with those treated with amoxicillin (56) (P<.01).. The recovery of potential pathogenic organisms (eg, Streptococcus pneumoniae, Staphylococcus aureus, beta-hemolytic streptococci, Haemophilus species, and Moraxella catarrhalis), as well as penicillin-resistant bacteria, was lower following completion of therapy in the cefdinir group (6 pathogens, including 5 that were penicillin resistant), compared with the amoxicillin group (27 pathogens, including 16 that were penicillin resistant) (P<.01).. This study illustrates the greater ability of cefdinir compared with amoxicillin to reduce the number of potential nasopharyngeal pathogens as well as penicillin-resistant bacteria in children with acute otitis media.

Topics: Acute Disease; Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents; Bacteria; Cefdinir; Cephalosporins; Child, Preschool; Female; Follow-Up Studies; Humans; Infant; Infant, Newborn; Male; Nasopharynx; Otitis Media with Effusion; Retrospective Studies; Treatment Outcome

A total of 2865 strains of the causative organisms isolated from the patients with acute pharyngitis and tonsillitis at the primary medical institutions were used in this study. The MICs of levofloxacin (LVFX) and other oral antimicrobial drugs were determined and evaluated by the NCCLS guideline. LVFX, cefditoren (CDTR) and cefcapene (CFPN) were potently active against 773 isolates of Hemophilus influenzae, the MIC50S of LVFX being < or = 0.06 microgram/mL and also the same as the MIC90S of LVFX. LVFX was the most active against 496 isolates of Enterobacteriaceae. The MIC50S of LVFX were < or = 0.06 microgram/mL and were lower than those of CDTR, cefdinir (CFDN) and cefpodoxime (CPDX) (MIC50S: 0.5 microgram/mL). The MIC90S of these cephems were markedly higher than the respective MIC50S, whereas MIC50 of LVFX was 0.12 microgram/mL, only twice the MIC50. Against the majority of Streptococcus pyogenes (555 isolates) and Streptococcus spp. (495 isolates), CDTR, CFDN, CPDX and CFPN were highly active (MICs: < or = 0.06 microgram/mL), and clarithromycin (CAM) and azithromycin (AZM) were also active against these organisms (MICs: 0.12 to 0.25 microgram/mL). Against S. pneumoniae (92 isolates), CDTR and CFDN were active (MIC50S: 0.12 and 0.25 microgram/mL, respectively). However, the MIC90S of these drugs were 4-8 times the MIC50S. Against Moraxella (Branhamella) catarrhalis (454 isolates), LVFX was potently active, the MIC90 of LVFX being < or = 0.06 microgram/mL and MIC90S of the other cephems being 0.5 microgram/mL or more. When the susceptibility of these strains to LVFX was evaluated by the NCCLS guideline, about 3% of other Streptococcus spp. were resistant to the drug but no test strains resistant to LVFX were detected in H. influenzae, S. pyogenes or Enterobacteriaceae. On the other hand, the percentages of strains susceptible to the cephems tested were 60-90%, which were quite different according to kinds of drugs and species used. Furthermore, the strains of S. pneumoniae resistant to CFDN and CPDX, and those to CAM and AZM were 21-25% and 50% or more, respectively, whereas no LVFX-resistant strains were detected. The major pathogens isolated from patients with pharyngitis and tonsillitis in the primary institutions were highly susceptible to LVFX. These results suggest that LVFX is a useful drug which is potently active against the strains resistant to oral cephem and macrolide antibiotics.

Topics: Acute Disease; Ampicillin; Anti-Infective Agents; Azithromycin; Cefdinir; Cefpodoxime; Ceftizoxime; Cephalosporins; Clarithromycin; Enterobacteriaceae; Haemophilus influenzae; Humans; Levofloxacin; Ofloxacin; Penicillin G; Pharyngitis; Streptococcus pneumoniae; Streptococcus pyogenes; Tonsillitis

The pathogenesis, bacteriology, diagnosis, and antimicrobial treatment of acute bacterial rhinosinusitis (ABRS) is reviewed. Most cases of ABRS arise as complications of the rhinosinusitis of colds and other acute viral respiratory infections. Nose blowing during colds may be a risk factor for ABRS by propelling bacteria-laden nasal fluid into the sinus cavity. The bacterial causes of ABRS continue to be S pneumoniae. H influenzae, other streptococcal species, M catarrhalis, anaerobes, and S aureus. Clinical diagnosis of ABRS is based on obtaining a history of a cold or influenza-like illness that is no better or worse after >/=7 days. A 10-day course of treatment with an antimicrobial effective against resistant S pneumoniae and H influenzae is recommended. A clinical trial was reviewed in which cefdinir was effective in treating ABRS.

Topics: Acute Disease; Anti-Bacterial Agents; Bacterial Infections; Cefdinir; Cephalosporins; Humans; Rhinitis; Sinusitis

A 58-year-old woman was admitted to our hospital because of renal dysfunction that continued to progress even after withdrawal of cefdinir, the presumed cause of acute renal failure. Renal histologic findings included interstitial fibrosis accompanied by moderate lymphocytic infiltration, and tubular atrophy with reduced numbers of epithelial cells. Mesangial cells and glomerular basement membranes were nearly normal. Scintigraphy with 67gallium disclosed diffuse abnormal accumulation in both kidneys. A lymphocyte stimulation test with cefdinir was positive. The patient was diagnosed with acute tubulointerstitial nephritis caused by cefdinir. Serum creatinine concentrations continued to rise after withdrawal of the drug, but steroid therapy was effective in normalizing renal function.

Topics: Acute Disease; Acute Kidney Injury; Anti-Infective Agents; Anti-Inflammatory Agents; Biopsy; Bronchitis; C-Reactive Protein; Cefdinir; Cephalosporins; Creatinine; Disease Progression; Drug Therapy, Combination; Famotidine; Female; Histamine H2 Antagonists; Humans; Kidney; Kidney Function Tests; Methylprednisolone; Middle Aged; Nephritis, Interstitial; Ofloxacin; Prednisolone; Radionuclide Imaging

Cefdinir (CFDN) was administered to pediatric patients with acute infectious disease. A summary of the results obtained is as follows. 1. Pharmacokinetic parameters were determined in a girl. In comparison to reported data in adults, Tmax was shorter, Cmax was slightly lower, and the plasma half life of CFDN was somewhat longer. 2. Clinical efficacy was studied in 11 children with acute tonsillitis (6 patients), scarlet fever (1 patient), acute pharyngitis (1 patient), acute pneumonia (1 patient), acute otitis media (1 patient) and acute cervical lymphadenitis (1 patient). Responses to the treatment were excellent in 7 (63.6%) and good in 2 (18.2%). 3. No adverse reactions were noted in this study.

Topics: Acute Disease; Administration, Oral; Age Factors; Bacterial Infections; Cefdinir; Cephalosporins; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Female; Humans; Male

Five percent fine granule preparation of cefdinir (CFDN, FK482) was administered to 30 patients with acute febrile respiratory tract infections (RTI) at 4.9-21.1 mg/kg/day divided into 3 portions. And 10% fine granule preparation of CFDN was also administered to 11 patients with acute febrile RTI and 1 patient with urinary tract infection at 10.0-20.0 mg/kg/day divided into 3 portions. Good clinical effects observed in 21 of 24 patients (87.5%) with acute pharyngitis, 12 of 13 patients (92.3%) with acute tonsillitis, 2 of 4 patients (50.0%) with pneumonia and a patient with urinary tract infection. From these patients, 34 causative organisms were isolated. Ten (83.3%) of 12 strains of Staphylococcus aureus, all 6 strains of Streptococcus pyogenes and 1 strain of Streptococcus pneumoniae, 6 (46.2%) of 13 strains of Haemophillus influenzae and 1 strain of Escherichia coli were eradicated from these patients. Among the patients with pneumonia, CFDN 20 mg/kg/day dose group showed better clinical responses and better bacteriological effects against H. influenzae among the patients given CFDN 20 mg/kg/day dose group than those given CFDN 5 mg/kg/day dose group. Side effects were noted in 2 cases, one case had soft stools and the other had diarrheas.

Topics: Acute Disease; Administration, Oral; Adolescent; Age Factors; Bacteria; Cefdinir; Cephalosporins; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Drug Resistance, Microbial; Female; Humans; Infant; Male; Respiratory Tract Infections; Urinary Tract Infections

Clinical evaluation in pediatrics on cefdinir (CFDN, FK482) (5% fine granules), a new oral cephem, was performed. 1. CFDN was administered to 112 pediatric patients with ages between 1 month to 13 years with various infections. Dose levels used were 3.0-8.9 mg/kg (mean 5.1 mg/kg) t.i.d. for 3-14 days (mean 6.7 days). The studied patients included 2 patients with scarlet fever, 6 with acute pharyngitis, 6 with acute rhinopharyngitis, 52 with acute purulent tonsillitis, 8 with acute bronchitis, 24 with acute pneumonia, 7 with acute urinary tract infections, 1 with acute vaginitis, and 6 with impetigo. Total doses ranged from 0.6 to 4.05 g. One hundred eleven of the 112 patients were evaluated for clinical efficacy and all the patients were evaluated for safety. 2. Clinical effects were excellent in 51 cases, good in 57, and fair in 3 with an extremely high efficacy rate of 97.3%. Efficacy rates were 100% in scarlet fever, acute pharyngitis, acute purulent tonsillitis, acute bronchitis, acute vaginitis and impetigo, and 83.3%, 95.7%, 85.7% in acute rhinopharyngitis, acute pneumonia, and acute urinary tract infections, respectively. Good clinical effects were observed regardless of diseases. 3. Causative organisms were identified in 79 cases, of which 71 were found to be monobacterial infections and 8 were found to be multi-bacterial infections. In mono-bacterial infections, clinical efficacies were 100% for those caused by Staphylococcus aureus/Streptococcus pyogenes/Streptococcus pneumoniae/beta-Streptococcus except those in A and B groups with an overall efficacy of 100% against Gram-positive cocci (GPC) and they were 89.5%, 100%, 100% for those caused by Haemophilus influenzae, Haemophilus parainfluenzae, and Escherichia coli, respectively, with an overall efficacy of 90.3% in Gram-negative rods (GNR). In multi-bacterial infections also, a clinical efficacy of 100% was obtained. 4. Bacteriological effects were studied for 89 strains in the 79 cases. The eradication rate for a few strains of S. pneumoniae was low, 25%, but it was 100% for S. aureus, with the same results for S. pyogenes, and beta-Streptococcus. The eradication rate on GPC was high 94.1%. Among GNR, 66.7% of E. coli, 50.0% of H. influenzae, and 71.4% of H. parainfluenzae was eradicated. The overall eradication rate for GNR was 55.3%, lower than that for GPC. Microbial substitutions were observed in 13 cases, with Haemophilus sp. replacing other bacteria. 5. Diarrhea and soft stools were not

Topics: Acute Disease; Administration, Oral; Age Factors; Bacteria; Bacterial Infections; Cefdinir; Cephalosporins; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Drug Resistance, Microbial; Female; Humans; Infant; Male

We studied pharmacokinetics and clinical effects of cefdinir (CFDN), a newly developed oral cephalosporin, and the following results were obtained. 1. Pharmacokinetics of CFDN in 2 patients were investigated. The 2 patients with ages of 8 years (36.5 kg, body weight) and 6 years (26.5 kg, body weight) were administered with 3 mg/kg of fine granules of CFDN on empty stomachs. Peak plasma levels of CFDN were 0.85 microgram/ml in one patient and 0.56 microgram/ml in the other. The 8-hour urinary recovery rate was 21.6% of the administered dose in one and was not calculable in the other. 2. Clinical effects of CFDN were studied in 25 children with various infectious diseases: 11 with acute pharyngitis, 1 with acute tonsillitis, 2 with acute laryngitis, 3 with acute bronchitis, 2 with acute bronchopneumonia, 4 with scarlet fever, 1 with acute otitis media, 1 with acute lymphadenitis. The efficacy rate was 96% (24/25), and the bacteriological eradication rate was 83.3% (10/12). 3. No side effects were noted. Clinical laboratory test values were investigated in 14 patients. There were no seriously abnormal laboratory test findings except a slight elevation of eosinophile and GPT.

Topics: Acute Disease; Administration, Oral; Adolescent; Age Factors; Bacteria; Cefdinir; Cephalosporins; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male; Respiratory Tract Infections