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Clinical outcome in children with culture-negative acute otitis media.
Pediatr Infect Dis J 2009; 28(12):1105-10PI

Abstract

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.

Authors+Show Affiliations

Pediatric Infectious Diseases Unit, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer-Sheva, Israel. eugenel@bgu.ac.ilNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

19935271

Citation

Leibovitz, Eugene, et al. "Clinical Outcome in Children With Culture-negative Acute Otitis Media." The Pediatric Infectious Disease Journal, vol. 28, no. 12, 2009, pp. 1105-10.
Leibovitz E, Nakash E, Givon-Lavi N, et al. Clinical outcome in children with culture-negative acute otitis media. Pediatr Infect Dis J. 2009;28(12):1105-10.
Leibovitz, E., Nakash, E., Givon-Lavi, N., Greenberg, D., Satran, R., Raiz, S., ... Dagan, R. (2009). Clinical outcome in children with culture-negative acute otitis media. The Pediatric Infectious Disease Journal, 28(12), pp. 1105-10. doi:10.1097/INF.0b013e3181b20e7a.
Leibovitz E, et al. Clinical Outcome in Children With Culture-negative Acute Otitis Media. Pediatr Infect Dis J. 2009;28(12):1105-10. PubMed PMID: 19935271.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical outcome in children with culture-negative acute otitis media. AU - Leibovitz,Eugene, AU - Nakash,Eyal, AU - Givon-Lavi,Noga, AU - Greenberg,David, AU - Satran,Robert, AU - Raiz,Semion, AU - Piglansky,Lolita, AU - Leiberman,Alberto, AU - Dagan,Ron, PY - 2009/11/26/entrez PY - 2009/11/26/pubmed PY - 2010/3/3/medline SP - 1105 EP - 10 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 28 IS - 12 N2 - 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. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/19935271/Clinical_outcome_in_children_with_culture_negative_acute_otitis_media_ L2 - http://Insights.ovid.com/pubmed?pmid=19935271 DB - PRIME DP - Unbound Medicine ER -