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Biomedical subjects

A Hoberman

Publications and source records attributed to A Hoberman.

At least 19 recordsLinked to original sources
PubMed2001

Vaccine prevention of acute otitis media.

The incidence of acute otitis media (AOM) in infants and young children has increased dramatically in recent years in the United States. AOM often follows upper respiratory tract infections due to pathogens such as respiratory syncytial virus (RSV), influenza virus, and parainfluenza virus (PIV). These viruses cause eustachian tube dysfunction that is critical to the pathogenesis of AOM. Vaccines against these viruses would likely reduce the incidence of AOM. In three previous studies, influenza virus vaccines reduced the incidence of AOM by 30% to 36%. Vaccines to prevent infections with RSV and PIV type 3 are undergoing clinical testing at this time. Streptococcus pneumoniae, nontypeable Haemophilus influenzae (NTHi), and Moraxella catarrhalis are the three most common AOM pathogens. Heptavalent pneumococcal conjugate vaccine is effective in preventing invasive disease and AOM caused by serotypes contained in the vaccine. Vaccine candidates for NTHi and M. catarrhalis are under development.

Acute Disease↗
PubMed2001

Bacteriologic and clinical efficacy of high dose amoxicillin/clavulanate in children with acute otitis media.

OBJECTIVES: To determine the bacteriologic and clinical efficacy of high dose amoxicillin/clavulanate (90/6.4 mg/kg/day) against common bacterial pathogens causing acute otitis media (AOM), including penicillin-resistant Streptococcus pneumoniae (PRSP). METHODS: In this open label multicenter study, 521 infants and children with AOM [mean age, 18.6 months; age < 24 months, n = 375 (72%)] were treated with amoxicillin/clavulanate 90/6.4 mg/kg/day in two divided doses for 10 days. Bilateral otitis media, previous episodes of AOM, antibiotic treatment within 3 months and day-care attendance were recorded in 60.1, 35.7, 50.2 and 38.2% of the children, respectively. Tympanocentesis was performed before the first dose and repeated on Days 4 to 6 for all children with S. pneumoniae at 22 centers and for all children with any pathogen at 3 centers. Clinical response was assessed at end of therapy. RESULTS: Pathogens were isolated from 355 (68%) of 521 enrolled children; 180 children underwent repeat tympanocentesis and were bacteriologically evaluable. Baseline pathogens were S. pneumoniae (n = 122 enrolled/93 bacteriologically evaluable), Haemophilus influenzae (n = 160/51), both (n = 37/32) and others (n = 36/4). Pathogens were eradicated from 172 (96%) of 180 bacteriologically evaluable children. Overall 122 (98%) of 125 isolates of S. pneumoniae were eradicated, including 31 (91%) of 34 PRSP isolates (penicillin MICs 2 to 4 micrograms/ml). Seventy-eight (94%) of 83 isolates of H. influenzae were eradicated. Symptoms and otoscopic signs of acute inflammation were completely resolved or improved on Days 12 to 15 in 263 (89%) of 295 clinically evaluable children with bacteriologically documented AOM. CONCLUSIONS: On the basis of bacteriologic outcome on Days 4 to 6 and clinical outcome on Days 12 to 15, we found that high dose amoxicillin/clavulanate (90/6.4 mg/kg/day) was highly efficacious in children with AOM, including those most likely to fail treatment, namely children < 24 months of age and those with infectious caused by PRSP.

Acute Disease↗
PubMed2001

Short term oral cefixime therapy for treatment of bacterial conjunctivitis.

BACKGROUND: There have been few controlled studies evaluating treatment of bacterial conjunctivitis beyond the newborn period. Topical therapy of bacterial conjunctivitis achieves a clinical cure but does not prevent acute otitis media (AOM). OBJECTIVES: The aim of this study was to compare systemic antibiotic therapy (cefixime) with topical therapy with polymyxin-bacitracin for treatment of acute bacterial conjunctivitis with regard to clinical and bacteriologic cure and prevention of AOM. METHODS: This study was a randomized, double blind, placebo-controlled trial of polymyxin-bacitracin ointment and oral placebo vs. topical placebo and oral cefixime in children with presumed acute bacterial conjunctivitis. Topical therapy was administered for 7 days; oral therapy was administered for 3 days. Bacterial cultures were obtained at entry and on Day 3 of treatment. Children were examined on Days 3 and 10 or if they worsened within 15 days of entry. RESULTS: Eighty children were enrolled in the study. Bacterial cultures of the conjunctiva were positive in 70% of children: Haemophilus influenzae (53.7%); Streptococcus pneumoniae (13.8%); H. influenzae and S. pneumoniae (1.2%); and Moraxella catarrhalis (1.3%). There were 7 (17.5%) bacteriologic failures among children receiving topical antibiotic and oral placebo and 15 (37.5%) bacteriologic failures among children receiving topical placebo and oral cefixime (P = 0.07 with Yates correction). There was no difference between study groups with regard to either clinical cure or the development of AOM. Nine children (11%), 5 who received active topical therapy and 4 who received active oral drug, developed AOM either during or within 15 days of study entry. CONCLUSION: Cefixime was not more effective than topical polymyxin-bacitracin in either the eradication of conjunctival colonization with respiratory pathogens or the prevention of AOM in children with acute bacterial conjunctivitis.

Acute Disease↗
PubMed1999

Treatment of urinary tract infections.

Treatment of UTI with oral antibiotics alone is generally effective, even in young children with pyelonephritis. Cefixime has a broad spectrum of activity and is suitable as an empiric agent in most cases. In patients who are unlikely to tolerate oral medications because of vomiting or who appear toxic on examination, hospitalization and initial treatment with i.v. therapy is indicated. In general, radiographic studies can be performed prior to completion of the primary course of antibiotics, and prophylactic treatment is unnecessary. Patients should receive instruction about the risk of recurrent infection and should be advised to seek medical attention when symptoms of UTI develop.

Administration, Oral↗
PubMed1999

Oral versus initial intravenous therapy for urinary tract infections in young febrile children.

BACKGROUND: The standard recommendation for treatment of young, febrile children with urinary tract infection has been hospitalization for intravenous antimicrobials. The availability of potent, oral, third-generation cephalosporins as well as interest in cost containment and avoidance of nosocomial risks prompted evaluation of the safety and efficacy of outpatient therapy. METHODS: In a multicenter, randomized clinical trial, we evaluated the efficacy of oral versus initial intravenous therapy in 306 children 1 to 24 months old with fever and urinary tract infection, in terms of short-term clinical outcomes (sterilization of the urine and defervescence) and long-term morbidity (incidence of reinfection and incidence and extent of renal scarring documented at 6 months by 99mTc-dimercaptosuccinic acid renal scans). Children received either oral cefixime for 14 days (double dose on day 1) or initial intravenous cefotaxime for 3 days followed by oral cefixime for 11 days. RESULTS: Treatment groups were comparable regarding demographic, clinical, and laboratory characteristics. Bacteremia was present in 3.4% of children treated orally and 5.3% of children treated intravenously. Of the short-term outcomes, 1) repeat urine cultures were sterile within 24 hours in all children, and 2) mean time to defervescence was 25 and 24 hours for children treated orally and intravenously, respectively. Of the long-term outcomes, 1) symptomatic reinfections occurred in 4.6% of children treated orally and 7.2% of children treated intravenously, 2) renal scarring at 6 months was noted in 9.8% children treated orally versus 7.2% of children treated intravenously, and 3) mean extent of scarring was approximately 8% in both treatment groups. Mean costs were at least twofold higher for children treated intravenously ($3577 vs $1473) compared with those treated orally. CONCLUSIONS: Oral cefixime can be recommended as a safe and effective treatment for children with fever and urinary tract infection. Use of cefixime will result in substantial reductions of health care expenditures.

Acute Disease↗
PubMed1998

Acute otitis media in children with bronchiolitis.

OBJECTIVE: We investigated the prevalence and the etiology of acute otitis media (AOM) in children with bronchiolitis to determine whether AOM in such children is due entirely or mainly to respiratory syncytial virus (RSV), in which case routine antimicrobial treatment would not be appropriate. METHODS: The study group consisted of children aged 2 to 24 months with bronchiolitis. In patients with AOM at entry, nasal washings for RSV enzyme-linked immunosorbent assay were obtained, and Gram-stained smear, bacterial culture, and reverse transcriptase polymerase chain reaction to detect the presence of RSV were performed on middle-ear aspirates. Patients without AOM were reevaluated at 48 to 72 hours, 8 to 10 days, and 18 to 22 days. RESULTS: Forty-two children with bronchiolitis were enrolled. Sixty-two percent had AOM at entry or developed AOM within 10 days. An additional 24% had or eventually developed otitis media with effusion. Only 14% remained free of both AOM and otitis media with effusion throughout the 3-week observation period. All patients with AOM had 1 or more bacterial pathogens isolated from one or both middle-ear aspirates. Of 33 middle-ear aspirates, Streptococcus pneumoniae was isolated in 15, Haemophilus influenzae in 8, Moraxella catarrhalis in 8, and Staphylococcus aureus in 2. Two middle-ear aspirates yielded 2 pathogens each; 2 aspirates had no growth. RSV was identified in 17 (71%) of 24 patients with AOM. CONCLUSION: Bacterial AOM is a complication in most children with bronchiolitis. Accordingly, in patients with bronchiolitis and associated AOM, antimicrobial treatment is indicated.

Acute Disease↗
PubMed1997

Efficacy of Auralgan for treating ear pain in children with acute otitis media.

OBJECTIVE: To determine the efficacy of Auralgan otic solution (combination product of antipyrine, benzocaine, and glycerin) compared with an olive oil placebo in the management of moderate to severe ear pain in children with acute otitis media (AOM). DESIGN: Children 5 years or older who presented with ear pain and eardrum findings indicative of AOM were randomly assigned to treatment with Auralgan or olive oil drops instilled into the external auditory canal(s) of the affected ear(s). All children were also treated with 15 mg/kg of acetaminophen in a single dose. Ear pain was assessed by means of 2 visual analog seales-a linear scale and a color scale-at study entry and 10, 20, and 30 minutes later (T0, T10, T20, and T30, respectively). Results of the measurements on the 2 scales were evaluated independently and were averaged to determine an ear pain score. A baseline ear pain score of at least 3 points was required for study entry. Four outcome measures regarding ear pain score at T10, T20, and T30 were used: (1) proportion of subjects who showed 50% reduction, (2) proportion of subjects who showed 25% reduction, (3) proportion of subjects who showed a 1 or more point reduction, and (4) mean score over time. SETTING: Primary care center and emergency department of a children's hospital. PARTICIPANTS: Fifty-four children aged 5 to 19 years with ear pain and AOM. RESULTS: The Auralgan and placebo groups were comparable regarding age, sex, race, laterality of AOM, and T0 ear pain score. By each of the 4 measures used, the response to treatment consistently favored the Auralgan group, but only at T30 were any differences statistically significant. CONCLUSION: In children with AOM-associated ear pain who are treated with acetaminophen, topically applied Auralgan appears likely to provide additional relief in varying degree within 30 minutes.

Acute Disease↗
PubMed1997

Urinary tract infections in young febrile children.

UTI is a common and important clinical problem in infants and young children, with a prevalence of 5.3% among febrile infants seen in our Emergency Department. White females with rectal temperature > or = 39 degrees C are at particularly high risk (prevalence, 17%). Several studies have highlighted the limitations of the standard urinalysis for identifying UTI in infants and young children and have recommended performance of both urinalysis and urine culture. Alternative methods such as dipstick urinalysis, although attractive because of ease of performance, are inadequate as a screen for UTI. Hemocytometer WBC counts of an uncentrifuged urine specimen can be performed in an office or hospital-based laboratory with minimal training. Performance of Gram-stained smears, however, is most appropriate for the hospital-based laboratory. In the hospital setting where both tests can readily be performed, the positive predictive value of the combination of pyuria and bacteriuria (85%) allows prompt institution of antimicrobial therapy before culture results are available, whereas the lower positive predictive value of the single finding of either pyuria or bacteriuria (40%) justifies delaying treatment decisions until culture results are available. In the office setting where hemocytometer counts can easily be performed, culturing only specimens with pyuria and those of children presumptively treated with antimicrobials will result in the identification of almost all patients with true UTI, sparing large health care expenditures. Although the urine culture is traditionally regarded as the gold standard of UTI, positive urine cultures may occur secondary to contamination or in cases of ABU, leading to a false diagnosis of UTI. In contrast we found pyuria to be a reliable marker to discriminate infection from colonization of the urinary tract. The sustained absence of an inflammatory response, on repeat UA within 24 h, constitutes strong evidence that infection is absent. Management of ABU is controversial; many experts recommend withholding antibiotics because eradication of low virulence organisms may be followed by colonization with more virulent species that cause pyelonephritis. Preliminary results of our ongoing treatment trial suggest that management of young febrile children with UTI as outpatients receiving oral cefixime is as efficacious as inpatient management with intravenous cefotaxime. Results of renal ultrasound and DMSA scan at the time of infection have not modified management in any patient. Accordingly selective rather than routine performance of ultrasound is recommended. A voiding cystourethrogram at 1 month and a DMSA scan 6 months later have been valuable in identifying patients with vesicoureteral reflux and renal scarring, respectively. Among patients initially identified as having acute pyelonephritis, the incidence of renal scarring at 6 months has been substantially more frequent (approximately 40%) than we had expected. However, the long term implications of small scars identified with renal scintigraphy remain to be determined.

Anti-Bacterial Agents↗
PubMed1997

Equivalent efficacy and reduced occurrence of diarrhea from a new formulation of amoxicillin/clavulanate potassium (Augmentin) for treatment of acute otitis media in children.

OBJECTIVE: To compare the safety and efficacy, in treating acute otitis media (AOM) in children, of a new formulation of amoxicillin/clavulanate potassium (Augmentin) oral suspension providing 45/6.4 mg/kg/day and administered twice daily (bid) for 5 and 10 days, respectively, with the safety and efficacy of the original formulation providing 40/10 mg/kg/day and administered three times daily (tid) for 10 days. STUDY DESIGN: Eight hundred sixty-eight children ages 2 months to 12 years with AOM were randomly assigned to one of the three treatment groups. Stringent criteria were used for the diagnosis of AOM and for determinations of "cure" and "improvement." Subjects were reexamined on Days 12 to 14 and 32 to 38. RESULTS: Among subjects whose treatment and follow-up conformed fully to protocol, the proportion of treatment successes (clinically cured or improved) on Days 12 to 14 was 78.8% (149 of 189) in the tid 10-day group, 86.5% (154 of 178) in the bid 10-day group and 71.1% (140 of 197) in the bid 5-day group. Corresponding values on Days 32 to 38 were 64.2% (95 of 148) in the tid 10-day group, 63.1% (94 of 149) in the bid 10-day group and 57.8% (93 of 161) in the bid 5-day group. None of the differences between the tid 10-day regimen and either of the 2 bid regimens were statistically significant, but the bid 10-day regimen was significantly more effective than the bid 5-day regimen in younger subjects. In the study population as a whole, results were similar to those in per protocol subjects. Overall the incidence of protocol-defined diarrhea was 26.7% (74 of 277) in the tid 10-day group, compared with 9.6% (27 of 280) in the bid 10-day group (P < 0.0001) and 8.7% (25 of 286) in the bid 5-day group (P < 0.0001). CONCLUSIONS: In comparison with the original formulation of Augmentin administered tid for 10 days in the treatment of AOM in children, the new formulation administered bid for 10 days provides at least equivalent efficacy and causes substantially less diarrhea. Administration for 5 days appears not to provide equivalent efficacy, but the difference appears limited to younger children and the margin of difference is small.

Acute Disease↗
PubMed1996

Is urine culture necessary to rule out urinary tract infection in young febrile children?

OBJECTIVE: To determine whether the absence of pyuria on the enhanced urinalysis can be used to eliminate the diagnosis of urinary tract infection, avoiding the need for urine culture and sparing large health care expenditures. DESIGN: Results of an enhanced urinalysis (hemocytometer counts and interpretation of Gram-stained smears) performed on uncentrifuged urine specimens obtained by catheter were correlated with urine cultures in young febrile children at the Children's Hospital of Pittsburgh Emergency Department. In a group of 4253 children (95% febrile) less than 2 years of age, pyuria was defined as > or = 10 white blood cells/mm3, bacteriuria as any bacteria on any of 10 oil immersion fields in a Gram-stained smear and a positive culture as > or = 50,000 colony-forming units/ml. A subgroup of 153 children with their first diagnosed urinary tract infection were enrolled in a separate treatment trial, acute phase reactants (peripheral white blood cell count, erythrocyte sedimentation rate and C-reactive protein) were obtained and 99Tc-dimercaptosuccinic acid renal scans were performed. RESULTS: The presence of either pyuria or bacteriuria and the presence of both pyuria and bacteriuria have the highest sensitivity (95%) and positive predictive value (85%), respectively, for identifying positive urine cultures. Because a white blood cell count in a hemocytometer is the technically simpler component of the enhanced urinalysis, we chose to analyze the false negative results and achievable cost savings of using pyuria alone as the sole criterion for omitting urine cultures. If in this study urine cultures had been performed only on specimens from children who had pyuria or were managed presumptively with antibiotics, cultures of 2600 (61%) specimens would have been avoided. Twenty-two of 212 patients with positive urine cultures would not have been identified initially. However, based on interpretation of acute phase reactants, initial 99Tc-dimercaptosuccinic acid scan results, response to management and incidence of renal scarring 6 months later, 14 of the 22 patients most likely had asymptomatic bacteriuria and fever from another cause. The remaining 8 patients probably had early urinary tract infection. CONCLUSIONS: The analysis of urine samples obtained by catheter for the presence of significant pyuria (> or = 10 white blood cells/mm3) can be used to guide decisions regarding the need for urine culture in young febrile children.

Bacteriological Techniques↗
PubMed1994

Pyuria and bacteriuria in urine specimens obtained by catheter from young children with fever.

Results of urinalysis and culture of 2181 urine specimens obtained by catheter from febrile children aged less than 24 months were analyzed to determine the following: (1) an optimal cutoff point in considering a bacterial colony count clinically "significant," (2) the accuracy of leukocyte esterase and nitrite tests in identification of pyuria and bacteriuria, and (3) the utility of pyuria (defined as > or = 10 leukocytes/mm3) in the discrimination of urinary tract infection from asymptomatic bacteriuria. Among 110 urine cultures with > or = 10,000 colony-forming units per milliliter, 92 (84%) had > or = 100,000 CFU/ml, 10 (9%) had 50,000 to 99,000 CFU/CFU/ml and 8 (7%) had 10,000 to 49,000 CFU/ml. Urine specimens with 1000 to 49,000 CFU/ml were more likely than specimens with > or = 50,000 CFU/ml to yield Gram-positive or mixed organisms (36/60 vs 7/109; p < 0.001). A count of < 10 leukocytes/mm3 was almost invariably associated with a sterile culture; a count of > or = 10 leukocytes/mm3 was found in 93 of 102 patients with > or = 50,000 CFU/ml. The dipstick leukocyte esterase test had sensitivities of 52.9% and 66.7% in detecting > or = 10 leukocytes/mm3 and > or = 20 leukocytes/mm3, respectively. The dipstick nitrite test had a sensitivity of 31.4% in detecting bacteriuria (> or = 50,000 CFU/ml). Acute pyelonephritis was diagnosed by a renal scan with dimercaptosuccinic acid labeled with technetium 99m in 50 (77%) of 65 patients with > or = 10 leukocytes/mm3 but in none of five patients with < 10 leukocytes/mm3 (p < 0.01). The findings in these five patients were consistent with colonization of the urinary tract rather than infection. For urine specimens obtained by catheter, we believe that urinary tract infection is best defined by both a leukocyte count > or 10/mm3 and a CFU count > or = 50,000/ml. This definition almost always discriminates among true urinary tract infection, bacteriuria resulting from contamination of the urine specimen, and asymptomatic bacteriuria.

Bacteriuria↗
PubMed1994

Comparative study of the safety and efficacy of clarithromycin and amoxicillin-clavulanate in the treatment of acute otitis media in children.

The safety and efficacy of clarithromycin was compared with those of amoxicillin-potassium calvulanate for the treatment of acute otitis media in children. In a multicenter, randomized, investigator-blinded trial, 180 patients (6 months to 12 years of age) with acute otitis media were allocated to receive either clarithromycin, 15 mg/kg in two divided doses (n = 90), or amoxicillin-clavulanate, 40 mg/kg in three divided doses (n = 90), for 10 days. Middle ear samples were obtained by tympanocentesis from 175 of 180 patients. Pathogens were isolated from 137 samples (76%). Eighty-six patients in each treatment group were considered for efficacy analysis. Clinical cure or improvement was achieved within 4 days after treatment in 80 (93%) of 86 patients receiving clarithromycin and in 82 (95%) of 86 patients receiving amoxicillin-clavulanate. Recurrence of infection was observed between 5 and 35 days after treatment in 9 (11%) of 80 patients in the clarithromycin group and in 8 (10%) of 82 patients in the amoxicillin-clavulanate group. Middle ear effusion was found with similar frequency at the end of therapy and at follow-up visits in both treatment groups. Mild gastrointestinal signs and symptoms, the most common side effects, were noted in 20% and 52% of patients in the clarithromycin group and the amoxicillin-clavulanate group, respectively (p < 0.001). We conclude that clarithromycin is a safe and effective antimicrobial agent for the treatment of acute otitis media in children.

Acute Disease↗