An Open-Label, Double Tympanocentesis Study of Levofloxacin Therapy in Children With, or at High Risk for, Recurrent or Persistent Acute Otitis Media

2006 ◽  
Vol 25 (12) ◽  
pp. 1102-1109 ◽  
Author(s):  
Adriano Arguedas ◽  
Ron Dagan ◽  
Michael Pichichero ◽  
Eugene Leibovitz ◽  
Jeffery Blumer ◽  
...  
Keyword(s):  
High Risk ◽  
Otitis Media ◽  
Acute Otitis Media ◽  
Open Label

A Multicenter, Open Label, Double Tympanocentesis Study of High Dose Cefdinir in Children With Acute Otitis Media at High Risk of Persistent or Recurrent Infection

2006 ◽  
Vol 25 (3) ◽  
pp. 211-218 ◽  
Author(s):  
Adriano Arguedas ◽  
Ron Dagan ◽  
Eugene Leibovitz ◽  
Alejandro Hoberman ◽  
Michael Pichichero ◽  
...  
Keyword(s):  
High Risk ◽  
Otitis Media ◽  
Acute Otitis Media ◽  
Recurrent Infection ◽  
High Dose ◽  
Open Label

scholarly journals Otitis media outcomes of a combined 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine and 13-valent pneumococcal conjugate vaccine schedule at 1-2-4-6 months: PREVIX_COMBO, a 3-arm randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Amanda Jane Leach ◽  
Edward Kim Mulholland ◽  
Mathuram Santosham ◽  
Paul John Torzillo ◽  
Peter McIntyre ◽  
...  
Keyword(s):  
Haemophilus Influenzae ◽  
Otitis Media ◽  
Conjugate Vaccine ◽  
Otitis Media With Effusion ◽  
Controlled Trial ◽  
Acute Otitis Media ◽  
Trial Registration ◽  
Open Label ◽  
Suppurative Otitis Media ◽  
Link Type

Abstract Background Aboriginal children living in Australian remote communities are at high risk of early and persistent otitis media, hearing loss, and social disadvantage. Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi) are the primary pathogens. We compared otitis media outcomes in infants randomised to either a combination of Synflorix™ (PHiD-CV10, with protein D of NTHi) and Prevenar13™ (PCV13, with 3, 6A, and 19A), with recommended schedules for each vaccine alone. We previously reported superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months. Methods In an open-label superiority trial, we randomised (1:1:1) Aboriginal infants at 28 to 38 days of age, to either Prevenar13™ (P) at 2–4-6 months (_PPP), Synflorix™ (S) at 2–4-6 months (_SSS), or Synflorix™ at 1–2-4 months plus Prevenar13™ at 6 months (SSSP). Ears were assessed using tympanometry at 1 and 2 months, combined with otoscopy at 4, 6, and 7 months. A worst ear diagnosis was made for each child visit according to a severity hierarchy of normal, otitis media with effusion (OME), acute otitis media without perforation (AOMwoP), AOM with perforation (AOMwiP), and chronic suppurative otitis media (CSOM). Results Between September 2011 and September 2017, 425 infants were allocated to _PPP(143), _SSS(141) or SSSP(141). Ear assessments were successful in 96% scheduled visits. At 7 months prevalence of any OM was 91, 86, and 90% in the _PPP, _SSS, and SSSP groups, respectively. There were no significant differences in prevalence of any form of otitis media between vaccine groups at any age. Combined group prevalence of any OM was 43, 57, 82, 87, and 89% at 1, 2, 4, 6, and 7 months of age, respectively. Of 388 infants with ear assessments at 4, 6 and 7 months, 277 (71.4%) had OM that met criteria for specialist referral; rAOM, pOME, or CSOM. Conclusions Despite superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months, there were no significant differences in prevalence of otitis media nor healthy ears throughout the first months of life. Trial registration ACTRN12610000544077 registered 06/07/2010 and ClinicalTrials.govNCT01174849 registered 04/08/2010.

scholarly journals Video Discharge Instructions for Acute Otitis Media in Children: A Randomized Controlled Open‐label Trial

2019 ◽  
Vol 26 (12) ◽  
pp. 1326-1335 ◽  
Author(s):  
Sheena Belisle ◽  
Andrei Dobrin ◽  
Sharlene Elsie ◽  
Samina Ali ◽  
Shaily Brahmbhatt ◽  
...  
Keyword(s):  
Otitis Media ◽  
Acute Otitis Media ◽  
Discharge Instructions ◽  
Open Label ◽  
Randomized Controlled ◽  
Open Label Trial

scholarly journals The clinical course of acute otitis media in high-risk Australian Aboriginal children: a longitudinal study

2005 ◽  
Vol 5 (1) ◽  
Author(s):  
Katherine B Gibney ◽  
Peter S Morris ◽  
Jonathan R Carapetis ◽  
Susan A Skull ◽  
Heidi C Smith-Vaughan ◽  
...  
Keyword(s):  
Longitudinal Study ◽  
High Risk ◽  
Otitis Media ◽  
Clinical Course ◽  
Acute Otitis Media ◽  
Australian Aboriginal ◽  
Aboriginal Children

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

2003 ◽  
Vol 22 (11) ◽  
pp. 943-949 ◽  
Author(s):  
EUGENE LEIBOVITZ ◽  
LOLITA PIGLANSKY ◽  
SIMON RAIZ ◽  
DAVID GREENBERG ◽  
KAMAL A. HAMED ◽  
...  
Keyword(s):  
Otitis Media ◽  
Clinical Efficacy ◽  
Acute Otitis Media ◽  
Open Label

scholarly journals Oral prednisolone for acute otitis media in children: protocol of a pilot randomised, open-label, controlled study (OPAL study)

2018 ◽  
Vol 4 (1) ◽  
Author(s):  
Respati W. Ranakusuma ◽  
Amanda R. McCullough ◽  
Eka D. Safitri ◽  
Yupitri Pitoyo ◽  
Widyaningsih ◽  
...  
Keyword(s):  
Otitis Media ◽  
Acute Otitis Media ◽  
Oral Prednisolone ◽  
Controlled Study ◽  
Open Label
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