Distribution, dynamics and antibiotic resistance patterns of Streptococcus pneumoniae serotypes causing acute otitis media in children in southern Israel during the 10 year-period before the introduction of the 7-valent pneumococcal conjugate vaccine.

OBJECTIVES: To determine the dynamics of serotype prevalence, potential coverage by pneumococcal conjugate vaccines (PCV) and antibiotic resistance patterns of Streptococcus pneumoniae causing acute otitis media (AOM) in children in southern Israel before PCV7 introduction in the routine immunization program in Israel. METHODS: All S. pneumoniae isolates from middle ear fluid from children with AOM during 1999-2008 were included. Prospectively collected demographic data on S. pneumoniae serotypes and antibiotic resistance patterns were analyzed. RESULTS: A total of 14,911 tympanocenteses yielded 5281 (35%) S. pneumoniae. Proportion of S. pneumoniae-AOM did not vary significantly (overall 35%; 33% in 2007; 38% in 2002 and 2003). The most frequent serotypes were 19F, 14, 23F and 19A; in both Jewish and Bedouin children; serotypes 6A and 19A contributed 6% and 10%, respectively, of all S. pneumoniae isolates. Serotypes included in PCV7, PCV10 and PCV13 represented 60%, 64%, 85% in Jewish children vs. 49%, 55% and 74%, respectively, in Bedouin children (P < 0.001). Nonsusceptibility to TMP/SMX decreased significantly, in parallel with a significant increase in the nonsusceptibility to erythromycin, clindamycin and in multidrug resistant (MDR) isolates. No changes were recorded in the proportion of S. pneumoniae isolates with penicillin MIC ≥ 1.0 µg/ml. The proportion of penicillin- and erythromycin-nonsusceptible and of MDR serotype 6A and 19A isolates increased significantly in Bedouin children. CONCLUSIONS: (1) No significant changes were recorded in the yearly proportions of serotypes 23F, 19F, 19A, 14 and 6A in both ethnic populations; (2) Potential coverage of the 3 PCVs was higher in Jewish children than in Bedouin children; (3) The relatively high coverage of macrolides- and multidrug-resistant S. pneumoniae by PCV13 and lack of increase in penicillin, erythromycin and multidrug nonsusceptibility among non-PCV13 isolates is encouraging.

Clinical outcome in children with culture-negative acute otitis media.

BACKGROUND: Culture-negative AOM is often milder and associated with lower local/systemic inflammatory responses than culture-positive AOM. STUDY OBJECTIVES: To compare the clinical outcome of culture-negative AOM with that of culture-positive AOM children. PATIENTS AND METHODS: Children aged 3 to 35 months with AOM were enrolled in 11 double-tympanocentesis antibiotic efficacy studies documenting both bacteriologic (days 4-6 of treatment) and clinical outcome (days 11-14, end of treatment). Univariate analysis (age, gender, ethnicity, previous AOM history, and antibiotic treatment) between culture-negative and culture-positive AOM patients was performed by Student t test, ANOVA, or chi2 test. Those found to be significant were further submitted to multivariable regression analysis. RESULTS: A total of 1088 patients (mean age, 11.95 +/- 5.96 months, 209 culture-negative and 879 culture-positive AOM) were enrolled. No differences were recorded between culture-negative AOM and culture-positive AOM patients in age, gender, ethnicity and number of previous episodes. Seventy-four percent (650/879) culture-positive AOM patients achieved bacteriologic eradication within 3 to 5 days. Successful outcome (cured + improved) was recorded in 90% (189/209) culture-negative AOM patients versus 86% (758/879) in culture-positive AOM (P = 0.086). Successful clinical outcome was more frequent in culture-negative than in culture-positive AOM without bacteriologic eradication (90% vs. 67% [154/229], P < 0.001). No difference in successful clinical outcome was found between culture-negative versus culture-positive AOM patients with bacterial eradication (90% vs. 93% [604/650], P = 0.24). Overall, the inclusion of culture-negative AOM patients in the evaluation of clinical failures rates in study patients decreased the total clinical failure rate by 9%. We present a hypothetical antibiotic efficacy study enrolling 300 patients in whom 2 drugs with different bacteriologic efficacy rates (A-90% and B-60%) were used. When the culture-negative cases (5% clinical failure) enrolled increased from 50/300 (16.7%) to 150/300 (50%), the overall clinical failure rate decreased by 36% (from 17.4% to 11.2%, P = 0.08) for the less efficacious drug, while remaining unmodified for the more efficacious drug (9.6% and 8.8%, respectively). CONCLUSIONS: (1) Clinical outcome in culture-negative AOM was similar to that of culture-positive AOM with bacteriologic eradication and both were superior to that of culture-positive AOM without eradication; (2) Inclusion of culture-negative AOM patients in series aiming at antibiotic efficacy may falsely improve the clinical outcome for antibiotics with reduced ability to eradicate AOM pathogens.

[Obstructive sleep apnea syndrome in young infants].

UNLABELLED: Obstructive sleep apnea syndrome (OSAS) has been reported among children aged 3-6 years. Adenotonsillar hypertrophy is the most common cause of OSAS. The upper airway obstruction results in repeated obstructive apneas and hypopneas, associated with oxygen desaturations and sleep fragmentation. OSAS in children is associated with higher respiratory morbidity as well as significant clinical consequences, mainly neurocognitive and behavioral problems, impaired growth and cardiac dysfunction. The objectives of the present study were to determine the clinical and sleep characteristics of OSAS in children younger than 2 years, and to evaluate morbidity and health care utilization of infants with OSAS. This retrospective study included 35 children younger than 2 years of age, referred for polysomnography because of suspected OSAS. The controL group included healthy children, matched by age, gender and pediatrician. RESULTS: A total of 33 infants were diagnosed with OSAS. Mean apnea/hypopnea index [AHI) was 18.7 +/- 18.1 events/ hour [range 1.3-90.2]. In 10 infants a pattern of intermittent hypoxemia was observed. Infants with OSAS demonstrated a higher number of primary care clinic visits (20.8 +/- 14 vs. 12.1 +/- 6.6, P < 0.02). A higher percentage of children with OSAS visited the emergency room (60.6% vs. 32.2%, P < 0.03), and was hospitalized (36.3% vs. 12.9%, P < 0.03). Duration of hospitalization was also higher in the OSAS group [23.2 +/- 14.1% vs. 3 +/- 2.1%, P < 0.05). The number of drug prescriptions was higher among the study group [25.9 +/- 21.8% vs. 13.6 +/- 10.1, P < 0.03). Thirteen patients underwent adenoidectomy with or without tonsillectomy, resulting in improvement of AHI, decreasing from 26.4 +/- 24 before to 3.6 +/- 4.5 events per hour after surgery (p < 0.01). CONCLUSIONS: OSAS can be found in infants younger than 2 years of age. OSAS at this young age is characterized by a higher morbidity in comparison to healthy children. Early diagnosis and treatment may prevent morbidity in young children with OSAS.

Epidemiologic and microbiologic characteristics of culture-positive spontaneous otorrhea in children with acute otitis media.

OBJECTIVES: We aimed to describe the epidemiologic and microbiologic characteristics of acute otitis media (AOM) with spontaneous otorrhea in children and compare it with AOM with intact tympanic membrane in children who underwent tympanocentesis. PATIENTS AND METHODS: All infants and young children aged <3 years with culture-positive AOM of < or =7 days duration diagnosed during 1999 to 2006 and in whom epidemiologic and microbiologic data were available, were analyzed. Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes were considered true AOM pathogens. Multivariable regression analysis models adjusting for age, gender, ethnicity, seasonality, previous antibiotics, AOM history, tympanocentesis history, and pathogens isolated, were used. RESULTS: Of 12,617 AOM patients from whom a middle ear fluid was obtained, 5247 (42%) culture-positive patients were enrolled; spontaneous otorrhea was observed in 822 (15%) patients. Patients with spontaneous otorrhea were older than patients with AOM who underwent tympanocentesis (15.8 +/- 8.2 vs. 9.7 +/- 6.7 months, respectively, P < 0.01; 36.9% vs. 69.1%, respectively, were <12 months, P < 0.01). S. pyogenes was found in a higher proportion (47/822, 5.7% vs. 44/4425, 1%, P < 0.01) and H. influenzae in a lower proportion (264/822, 32.1% vs. 1805/4425, 40.8%, P < 0.01) among patients with spontaneous otorrhea than in patients with AOM and tympanocentesis. In the multivariate model, Bedouin ethnicity (OR: 1.5, 95% CI: 1.2-1.7, P < 0.001), age (OR: 1.1, 95% CI: 1.0-1.11, P < 0.001) for each consecutive month, lack of antibiotic treatment for the 48 hours preceding diagnosis (OR: 2.1, 95% CI: 1.7-2.6, P < 0.001), > or =1 previous AOM episode (OR: 3.2, 95% CI: 2.6-4.0, P < 0.001), >1 previous tympanocentesis (OR: 1.4, 95% CI: 1.4-1.7, P = 0.001), and infection with S. pyogenes (OR: 8.2, 95% CI: 5.4-12.3, P < 0.001) were independent risk factors for AOM presenting as spontaneous otorrhea. CONCLUSIONS: AOM presenting as spontaneous otorrhea in patients less than 3 years of age is characterized by older age, previous repeated tympanocenteses, > or =1 previous AOM episodes, lack of recent antibiotic treatment, and infection with S. pyogene.

Rates of tympanic membrane closure in double-tympanocentesis studies.

BACKGROUND: Data on the outcome of tympanic membrane (TM) closure after tympanocentesis in acute otitis media (AOM) patients is limited. OBJECTIVES: To analyze the dynamics of TM perforation closure after 1 or 2 tympanocentesis procedures performed at diagnosis and during AOM treatment. PATIENTS AND METHODS: Study population included 113 children enrolled in 4 double-tympanocentesis studies. Only the files of patients whose first and second examination were performed by the same 2 otorhinolaryngologists were analyzed. Middle ear fluid (MEF) was cultured on day 1 and days 4-6, the latter only in initially culture-positive patients. Patients were also examined on days 11-14 and followed until days 22-28. RESULTS: Ninety-three (82%) patients underwent tympanocentesis on days 4-6; 103 (91%) and 95 (84%) were evaluable on days 11-14 and 22-28, respectively. One hundred seventy-three ears underwent tympanocentesis on day 1 and 139 on days 4-6. Ninety-seven (86%) patients had positive MEF cultures. One hundred fifty-three (88%) tympanocentesis procedures performed at enrollment were closed on days 4-6. No differences were recorded in the closure rates as function of patient age, previous AOM history, MEF culture positivity, pathogens isolated at enrollment, and pathogen eradication on days 4-6. The 20 eardrums still open on days 4-6 were closed on days 11-14. Eleven (9%) of the evaluable ears tapped on days 4-6 were not closed on days 11-14 and 9 of 10 were closed on days 22-28. CONCLUSIONS: TM perforation closed in most cases within a few days regardless of patient and disease characteristics, and 2 consecutive tympanocentesis procedures performed at short-time intervals are associated with good TM closure rates.

Persistence of pathogens despite clinical improvement in antibiotic-treated acute otitis media is associated with clinical and bacteriologic relapse.

BACKGROUND: Pathogen eradication in patients with acute otitis media (AOM) is associated with a reduced risk of clinical failures, but most children in whom middle ear fluid (MEF) culture remains positive show clinical improvement or clinical cure. We investigated the relationship between MEF culture-positivity during treatment in patients with clinical improvement/cure, and the occurrence of subsequent AOM. METHODS: A total of 673 patients with culture-positive MEF were enrolled in double-tympanocentesis studies and followed for 3 weeks after completion of treatment. RESULTS: On day 4-6, 189/673 (28%) patients had culture-positive MEFs. Patients with clinical improvement/cure on day 11-14 (end of treatment) despite having culture-positive MEF on day 4-6 more often had recurrent AOM episodes (53/151, 35%) than those with culture-negative MEF (114/476, 24%; P = 0.007). 41/53 (77%) culture-positive patients with clinical improvement/cure on day 11-14 underwent tympanocentesis when AOM recurred and 29/41 (71%) were culture-positive. Pulsed field gel electrophoresis identity between pathogens at recurrence and those persisting on day 4-6 was found in 19/29 (66%) compared with 31/86 (36%) of the evaluable patients with recurrence and culture-negative MEF on day 4-6 (P = 0.005). CONCLUSIONS: (1) Failure to eradicate MEF pathogens during antibiotic treatment is associated with clinical recurrences, even in patients showing clinical improvement/cure at end of treatment; (2) these recurrences are mostly caused by pathogens initially present in MEF and persisting during treatment.

Conservative nonsurgical treatment of a child with otogenic lateral sinus thrombosis.

We present the case of a 5-year-old boy with otogenic lateral sinus thrombosis that developed after acute mastoiditis, with no prior ear disease. He was treated with myringotomy and antibiotics alone, with no surgical intervention. This approach was followed owing to his good general condition, the prompt response to the antimicrobial treatment, and no evidence of suppurative disease. Sinus recanalization was evident on the follow-up computed tomography 4 months later. We believe that in selected cases of otogenic lateral sinus thrombosis, secondary to an acute ear infection with early response to antibiotic therapy, conservative treatment may be considered and surgical intervention may be withheld.

A prospective randomized double-blind trial of fibrin glue for reducing pain and bleeding after tonsillectomy.

OBJECTIVES: Varying surgical techniques as well as a large selection of analgesics and other medications have been evaluated over the years in the hopes of reducing post-tonsillectomy pain. Several publications in recent years have demonstrated the efficacy of fibrin glue in reducing post-tonsillectomy bleeding and pain. The objectives of this study were to evaluate the effect of fibrin glue on pain and bleeding after tonsillectomy. STUDY DESIGN: A prospective randomized double-blind study was performed on 168 consecutive patients undergoing tonsillectomy for obstructive sleep apnea and chronic tonsillitis. METHODS: Patients were randomly assigned to the treatment protocol. In the study group, the tonsillar beds were coated with fibrin glue (Quixil, OMRIX biopharmaceuticals) at the end of the operation. Patients in the controlled group underwent tonsillectomy without the use of fibrin glue. The patients were then monitored for postoperative bleeding, and a patient-based pain assessment instrument was used to evaluate pain, ability to eat and analgesics consumption for 10 days after surgery. RESULTS: Ninety-six patients returned for postoperative follow up and filled in the questionnaire. As our medical center is the only hospital in the southern district of Israel and we hospitalize every person who presents with post-tonsillectomy bleeding, we can assume that any patient from either group who presented with post-tonsillectomy bleeding would be familiar to us. Analysis showed that no statistically significant differences relating to postoperative pain, bleeding, use of analgesics and postoperative eating resumption were detected between the patients treated with fibrin glue and controls. CONCLUSIONS: We cannot substantiate a significant beneficial effect of fibrin glue in post-tonsillectomy pain control, prevention of bleeding or facilitating eating and thus find no indication for the routine use of fibrin glue in tonsillectomy.

Failure to achieve early bacterial eradication increases clinical failure rate in acute otitis media in young children.

BACKGROUND: The objective of this study was to determine the association between early bacteriologic failure and clinical failure in acute otitis media (AOM). METHODS: Children with AOM aged 3-35 months enrolled in studies documenting both bacteriologic outcomes by tympanocentesis on day 4-6 and clinical outcomes on day 11-16 (immediate posttreatment visit) constituted our study group. Bacteriologic outcomes were studied for children with AOM caused by Streptococcus pneumoniae, nontypeable Haemophilus influenzae or both. The relative risk (RR) for clinical failure of children with bacteriologic failure compared with children with bacteriologic eradication was the main outcome measure. RESULTS: Nine hundred seven episodes were analyzed. Clinical failure occurred in 7.3% of 660 patients with bacterial eradication versus 32.8% of 247 patients with bacteriologic failures. The overall RR (95% confidence interval) for clinical failure was 4.41 (95% CI: 3.19-6.11), with little variation between pathogens. After correction for age, gender, ethnic origin, previous otitis history, and previous antibiotic treatment, the rate was 6.52 (95% CI: 4.26-9.99). Across clinical studies with 8 antibiotic drug regimens for AOM, the rate of clinical failure correlated with bacteriologic failure (r = 0.8967; P = 0.003). CONCLUSIONS: In young children with culture-positive AOM, failure to eradicate the pathogen from middle ear fluid within the first few days of treatment leads to a significant risk for clinical failure.

Is bilateral acute otitis media clinically different than unilateral acute otitis media?

BACKGROUND: Information regarding the specific characteristics of bilateral acute otitis media (BAOM) versus unilateral acute otitis media (UAOM) is lacking. OBJECTIVES: To compare the epidemiologic, microbiologic, and clinical characteristics of BAOM with UAOM in children. PATIENTS AND METHODS: 1026 children aged 3-36 months (61%, <1 year of age) with AOM were enrolled during 1995-2003. All patients had tympanocentesis and middle ear fluid (MEF) culture at enrollment. Clinical status was determined by a clinical/otologic score evaluating severity (0 = absent to 3 = severe, maximal score 12) of patient's fever and irritability and tympanic membrane redness and bulging. Multivariate logistic regression models were used to estimate the risk of BAOM and UAOM presenting with a high severity score (> or =8). RESULTS: Six-hundred twenty-three (61%) patients had BAOM. Positive MEF cultures were recorded in 786 (77%) patients. More patients with BAOM had positive MEF cultures than patients with UAOM (517 of 623, 83% versus 269 of 403, 67%; P < 0.01). Nontypable Haemophilus influenzae was more common in BAOM than in UAOM (390 of 623, 63% versus 170 of 430, 42%; P < 0.01). Overall, the clinical/otologic score showed higher severity in culture-positive than in culture-negative patients (8.2 +/- 2.0 versus 7.7 +/- 2.2; P < 0.001) and in BAOM than in UAOM (8.3 +/- 2.1 versus 7.8 +/- 2.1; P = 0.001). Clinical/otologic score of > or =8 was more frequent in BAOM than in UAOM patients (371, 61.8% versus 200, 51.3%; P = 0.001). The estimated risk for BAOM patients (compared with UAOM patients) to present with a score > or =8 was 1.5. The association between BAOM and clinical/otologic score > or = 8 was maintained after adjustment for age, previous AOM history, and culture results at enrollment. CONCLUSIONS: (1) BAOM is frequent; (2) Nontypable H. influenzae is more frequently involved in the etiology of BAOM than of UAOM; (3) The clinical picture of BAOM is frequently more severe than that of UAOM, but overlap of clinical symptoms is common.

The effect of adenotonsillectomy on children suffering from obstructive sleep apnea syndrome (OSAS): the Negev perspective.

OBJECTIVE: To present the Negev perspective in recent decades as to the effect of adenotonsillectomy regarding clinical and polysomnographic features, cardiopulmonary morbidity, growth, neurocognitive function, health care services utilization, and enuresis by reviewing current related literature. METHODS: All relevant published data by the Soroka University Medical Center and related community medical services were reviewed and compared to MEDLINE linked literature regarding aspects of childhood obstructive sleep apnea published through November 2005. RESULTS: Published data support a significant effect of adenotonsillectomy on the associated co morbidities: adenotonsillectomy resulted in the reduction of pulmonary hypertension, improved growth as a result of an increase in growth hormone secretion, improvement of neurocognitive function to the normal range, reduction in nocturnal enuresis, as well as reducing general morbidities, as reflected by the reduction in health care utilization. However, there are still uncertainties relating to major aspects. There is no specific definition for OSAS grading, or for generating a guideline for surgical treatment and refinement of the indications of T&A. CONCLUSIONS: Adenotonsillectomy has a beneficial effect on children with OSAS, however, further research is required before recommendations for the treatment of OSAS in children can be formulated.

Adenotonsilectomy improves enuresis in children with obstructive sleep apnea syndrome.

OBJECTIVES: To evaluate the prevalence of nocturnal enuresis (NE) in children diagnosed with obstructive sleep apnea syndrome (OSAS) and the effect of tonsillectomy and adenoidectomy on enuresis. DESIGN, SETTING, AND PARTICIPANTS: All children 4-18 years of age who underwent polysomnography (PSG) between January 2003 and May 2004 were included (n=161). The evaluation was based on a retrospective review of a standard sleep questionnaire and a full overnight PSG, followed by an additional structured telephone questionnaire performed 9 months after adenotonsillectomy (T&A) (range 5-14). RESULTS: We identified 144 (89%) children with an apnea hypopnea index >1. Of these 144 children, 42 [29.2% (95% CI, 21.8-36.6)] were reported to have enuresis, 27 of these 42 underwent T&A. Among the 27 enuretic children who had undergone adenotonsillectomy, 74.1% had 3 or more wet nights per week before the procedure compared to 37%, 1 month after [n=27 (chi2=3.308, McNemar pv<0.0001)]. Of the 27 children who underwent adenotonsillectomy, any decrease in enuresis severity was reported by 70.4% (95% CI 53.2-87.62), while in 56% of these 27 (95% CI 41.96-70.06) it occurred 1 month postoperatively. In 11/27 children (41%), enuresis totally disappeared within 1 month, while in 3/27 (11%) enuresis disappeared throughout the remaining time of follow-up. CONCLUSIONS: Obstructive sleep apnea in children is frequently associated with nocturnal enuresis. Adenotonsillectomy has a favorable therapeutic effect on enuresis in children with obstructive sleep apnea presenting this symptom.

Acute otitis media caused by Streptococcus pyogenes in children.

BACKGROUND: Streptococcus pyogenes, or group A beta -hemolytic Streptococcus (GAS), is an important causative agent of bacterial pharyngotonsillititis and skin, soft-tissue, and invasive infections. Although it is also an important pathogen in acute otitis media (AOM), its exact role has not been determined. METHODS: Patients aged 0-18 years with AOM, from whom a specimen of middle-ear fluid was obtained and cultured during 1999-2003, were enrolled. Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and GAS were considered pathogens. Information collected included demographic characteristics, clinical history, and signs and symptoms. RESULTS: GAS otitis was observed in 350 (3.1%) of 11,311 episodes (of which 117 were also culture-positive for other pathogens). The other 10,961 episodes involved H. influenzae only (n = 2507), S. pneumoniae only (n = 2131), dual infection with H. influenzae and S. pneumoniae (n = 1290), M. catarrhalis only (n = 129), and other combinations of pathogens (n = 271). Increased age and Jewish ethnicity were independent, significant, positive risk factors for GAS AOM, and fall season was a negative risk factor. Episodes of GAS infection were less frequently bilateral, febrile, and accompanied by other systemic findings than were other episodes of other types of infection. Most patients with GAS AOM presented with acute drainage from the ears. A lower proportion of cases of AOM were due to GAS in children with recurrent AOM and in patients recently treated with antibiotics, compared with patients with AOM who did not have these factors. The risk for mastoiditis was highest among patients with GAS AOM, compared with patients infected with other pathogens: 11.6 episodes per 1000 episodes of GAS AOM, compared with 2.2, 0.3, and 0 episodes of mastoiditis per 1000 episodes of AOM due to S. pneumoniae, H. influenzae, and M. catarrhalis, respectively. CONCLUSION: Compared with AOM caused by pathogens other than GAS, GAS AOM is characterized by older age and higher local aggressiveness manifested by lower rates of fever and respiratory symptoms and higher rates of tympanic perforation and mastoiditis.

Acute otitis media-diagnosis and treatment in the era of antibiotic resistant organisms: updated clinical practice guidelines.

The treatment of children with AOM has to rely on an accurate diagnosis and a clear discrimination between AOM and serous otitis media. The last decade has seen major changes in the epidemiology of AOM with an earlier onset of disease and a greater proportion of children with recurrent/complicated AOM. The processes of changing susceptibility of bacterial pathogens added a major problem in treatment selection. Tastier, more efficient, safe and conveniently-dosing as well as cost effective drugs are required to achieve adherence to therapy. The recent published guidelines for the treatment of AOM in the present era of pneumoccocal resistance represent a major step forward in the approach to the management of this disease by establishing a clear hierarchy among the various therapeutic agents. A 48-72 h observation option without use of antibacterial therapy in selected children with uncomplicated AOM should be promoted. Immunization against S. pneumoniae with the heptavalent pneumococcal conjugated vaccines was showed to result in a decrease in the frequency of AOM caused by this pathogen, including AOM caused by antibiotic-resistant S. pneumoniae.

Nasopharyngeal carriage of Streptococcus pneumoniae at the completion of successful antibiotic treatment of acute otitis media predisposes to early clinical recurrence.

OBJECTIVE: We sought to investigate the role of Streptococcus pneumoniae (SP) nasopharyngeal (NP) colonization after successful antibiotic treatment (Rx) of acute otitis media (AOM) in recurrent AOM (RAOM). PATIENTS AND METHODS: NP cultures were obtained from 494 (93%) of 530 patients at the end of antibiotic treatment (EOT). RESULTS: At enrollment, middle ear fluid (MEF) cultures in 418 (79%) of 530 patients were positive for pathogens. At EOT, NP cultures in 208 (42%) of 494 patients were positive for SP. RAOM was found in 130 (26%) of 494 patients: 66 (32%) of 208 with SP-positive NP and 64 of 286 (22%) without SP-positive NP at EOT (P=.026). MEF was positive for SP during RAOM in 34 (61%) of 56 patients with SP-positive NP and 17 (36%) of 47 patients without SP-positive NP at EOT (P=.022). The same serotype was identified in 24 (80%) of 30 SP pairs; complete identity was found between isolates in 22 (96%) of 23 SP pairs. CONCLUSIONS: Early RAOM was more commonly caused by SP if the organism was present in NP at EOT during the initial AOM episode. Most SP-RAOM episodes were caused by SP isolates present in NP at EOT during the previous AOM episode.

Gelfoam plug tympanoplasty concomitant with removal of retained ventilation tubes.

OBJECTIVE: To review the charts of patients treated using a gelfoam plug and to determine the efficacy of its use as a grafting material for prevention of perforation when removing retained ventilation tubes. METHOD: Following removal of the retained tube, excision and debridement of the rim of the perforation, the perforation was plugged with gelfoam material. Between February 1998 and July 2002, we used this procedure in 27 patients aged 15 years and younger, on a total of 36 ears. RESULTS: In all 27 cases, complete healing of the perforation was attained. CONCLUSION: A minimal tympanoplastic procedure using gelfoam graft concomitantly with tube removal is effective in prevention of perforation resulting from delayed spontaneous extrusion.

An improved device for posterior rhinomanometry to measure nasal resistance.

Rhinomanometry is a method for measuring nasal resistance for the purpose of providing an objective evaluation of nasal patency. Posterior rhinomanometry is accomplished without the use of a mask, thus allowing the patient to breathe naturally. Here, we report on the improvements we have made to the existing posterior rhinomanometry system. In this system, nasal airflow is measured indirectly by measuring the pressure differential across a small mesh window in the body plethysmograph. We have calibrated this measurement and developed software that automatically provides the correct values for all airflow rates. Also, we have developed software that automatically corrects for the phase shift caused by the plethysmograph structure. These refinements should provide more accurate values for nasal resistance.

Relationship among peripheral leukocyte counts, etiologic agents and clinical manifestations in acute otitis media.

OBJECTIVES: To analyze the peripheral leukocyte counts of children with acute otitis media (AOM) in relation to etiology, age, clinical symptoms and signs, prior antibiotic treatment, previous AOM history and pathogen eradication during antibiotic therapy. PATIENTS AND METHODS: Leukocyte counts were determined at diagnosis and on days 4 to 6 of therapy in patients age 3 to 36 months with AOM enrolled in double tympanocentesis studies. Clinical status was determined by a clinical score evaluating severity of fever, irritability and tympanic membrane redness and bulging. RESULTS: Of 771 enrolled patients, culture-positive middle ear fluid was reported in 590 (77%): 294 (50%) Haemophilus influenzae; 150 (25%) Streptococcus pneumoniae; 127 (21%) H. influenzae and S. pneumoniae together; 9 (2%) Moraxella catarrhalis; and 10 (2%) others. Mean leukocyte count +/- sd in patients with AOM caused by S. pneumoniae (15.7 +/- 6.7 cells x 10/mm) was significantly higher than those of patients with AOM caused by H. influenzae (13.7 +/- 5.8 cells x 10/mm) and patients with culture-negative AOM (13.8 +/- 5.6 cells x 10/mm), P < 0.01 for each comparison. Mean absolute neutrophil count (ANC) +/- sd was higher in patients with AOM caused by S. pneumoniae (8.6 +/- 5.1 cells x 10/mm) than in patients with AOM caused by H. influenzae (6.5 +/- 4.0 cells x 10/mm) or culture-negative patients (6.5 +/- 4.4 cells x 10/mm), P < 0.05 for each comparison. When multivariant regression analysis was used, S. pneumoniae etiology and fever (body temperature > or = 38 degrees Celsius) were independent factors, each significantly associated with leukocyte and ANCs. A significant correlation was found between leukocyte and ANCs and higher clinical scores in patients with pneumococcal AOM (P = 0.01, r = 0.21 and P < 0.01, r = 0.27, respectively). The mean leukocyte count on Days 4 to 6 was lower than on Day 1 (11.5 +/- 4.1 compared with 14.2 +/- 6.0 cells x 10/mm, P < 0.01). When paired (Day 1 and Days 4 to 6) examinations were analyzed, the leukocyte counts were lower on Days 4 to 6 irrespective of bacterial eradication or persistence. CONCLUSIONS: Significantly higher leukocyte counts and ANCs were found in pneumococcal AOM than in AOM caused by H. influenzae or in culture-negative AOM. A significant decrease in leukocyte counts was found during antibiotic therapy for AOM, regardless of etiology and bacteriologic outcome. Isolation of S. pneumoniae and fever were each significantly associated with increased peripheral leukocyte and ANCs.

Bacteriologic and clinical efficacy of oral gatifloxacin for the treatment of recurrent/nonresponsive acute otitis media: an open label, noncomparative, double tympanocentesis study.

BACKGROUND: Gatifloxacin is an 8-methoxyfluoroquinolone with good activity against respiratory pathogens. OBJECTIVES: To document the bacteriologic and clinical efficacy of gatifloxacin in recurrent/nonresponsive acute otitis media (AOM). METHODS: One hundred sixty patients 6 to 48 months of age with recurrent/nonresponsive AOM received gatifloxacin suspension (10 mg/kg once daily for 10 days). Recurrent AOM was defined as > or =3 AOM episodes during the previous 6 months or > or =4 AOM episodes during the previous 12 months. Nonresponsive AOM was defined as AOM occurring < or =14 days after completing antibiotic treatment or not improving after > or =48 h of therapy. Middle ear fluid (MEF) obtained by tympanocentesis pretreatment (Day 1) and 3 to 5 days after initiation of treatment (Days 4 to 6) was cultured. Additional MEF cultures were obtained if clinical failure or recurrence of AOM occurred. Bacteriologic failure was defined by culture-positive MEF during treatment. Patients were followed until Days 22 to 28. Susceptibility was determined by broth microdilution. RESULTS: One hundred twenty-eight (80%) patients completed treatment, and 32 discontinued the study prematurely (adverse events, 17; lost to follow-up, 10; consent withdrawal, 3; and laboratory abnormalities, 2). From 89 patients (median age, 1 year; median number of prior AOM episodes, 4; range, 0 to 12), 121 pathogens were recovered: Haemophilus influenzae, 74 (61%); Streptococcus pneumoniae, 36 (30%); Moraxella catarrhalis, 9 (7%); and Streptococcus pyogenes, 2 (2%). The 36 S. pneumoniae isolates were susceptible to gatifloxacin (MIC50 0.25 microg/ml); 26 of 36 (72%) were penicillin-nonsusceptible (15 fully resistant). All 74 H. influenzae isolates were susceptible to gatifloxacin (MIC < or = 0.03 mg/ml). Fourteen of 74 (19%) and 9 of 9 (100%) H. influenzae and M. catarrhalis isolates, respectively, produced beta-lactamase. Bacteriologic eradication was achieved for 118 of 121 (98%) pathogens: 74 of 74 H. influenzae; 34 of 36 (94%) S. pneumoniae; 9 of 9 M. catarrhalis; and 1 of 2 S. pyogenes. Clinical improvement/cure at end of treatment was seen in 103 of 114 (90%) clinically evaluable patients. Clinical recurrence of AOM after completion of therapy occurred in 31 patients. Of the 27 recurrent AOM cases in which tympanocentesis was performed, there were 16 (59%) new infections, 4 (15%) culture-negative results and only 7 (26%) true bacteriologic relapses. Adverse events were recorded in 21 of 160 (13%) patients: vomiting, 16; diarrhea, 3; maculopapular rash, 2. No articular adverse events were recorded. CONCLUSION: Gatifloxacin is efficacious and safe for the treatment of recurrent/nonresponsive AOM.