Page last updated: 2024-10-25

ciprofloxacin and Middle Ear Effusion

ciprofloxacin has been researched along with Middle Ear Effusion in 25 studies

Ciprofloxacin: A broad-spectrum antimicrobial carboxyfluoroquinoline.
ciprofloxacin : A quinolone that is quinolin-4(1H)-one bearing cyclopropyl, carboxylic acid, fluoro and piperazin-1-yl substituents at positions 1, 3, 6 and 7, respectively.

Research Excerpts

ExcerptRelevanceReference
"To investigate the efficacy, safety, and microbiology of a thermosensitive otic suspension of ciprofloxacin (OTO-201) in children with bilateral middle ear effusion undergoing tympanostomy tube placement."9.22Phase 3 Trials of Thermosensitive Ciprofloxacin Gel for Middle Ear Effusion in Children with Tubes. ( Bear, M; LeBel, C; Moss, JR; Park, AH; White, DR, 2016)
" Safety was assessed for serious adverse events and treatment-emergent adverse events using audiometry, otoscopy, and tympanometry."6.82Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials. ( Bear, M; Don, D; Koempel, J; LeBel, C; Mair, EA; Park, AH, 2016)
"To investigate the efficacy, safety, and microbiology of a thermosensitive otic suspension of ciprofloxacin (OTO-201) in children with bilateral middle ear effusion undergoing tympanostomy tube placement."5.22Phase 3 Trials of Thermosensitive Ciprofloxacin Gel for Middle Ear Effusion in Children with Tubes. ( Bear, M; LeBel, C; Moss, JR; Park, AH; White, DR, 2016)
"This study demonstrated that treatment with a combination of topical ciprofloxacin and corticosteroid decreased the middle ear effusion when compared with the control group and that ciprofloxacin/dexamethasone suspension reduced the severity of LPS-induced experimental otitis media more than ciprofloxacin/hydrocortisone did."3.77Effect of ciprofloxacin/dexamethasone versus ciprofloxacin/hydrocortisone on lipopolysaccharide-induced experimental otitis media. ( Chung, YS; Dattaray, P; Jahng, P; Jung, T; Kim, YH; Martin, D; Nyc, MA; Pudrith, C; Wall, GM, 2011)
" Safety was assessed for serious adverse events and treatment-emergent adverse events using audiometry, otoscopy, and tympanometry."2.82Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials. ( Bear, M; Don, D; Koempel, J; LeBel, C; Mair, EA; Park, AH, 2016)
"Ciprofloxacin/dexamethasone treatment is also superior to improvement in clinical response by visit, absence of otorrhea by visit, and reduction of otorrhea volume by visit."2.71Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes. ( Anon, JB; Conroy, PJ; Dupre, SJ; Hogg, G; Kreisler, LS; Lanier, B; McLean, C; Potts, S; Reese, B; Roland, PS; Stroman, DW; Wall, GM, 2004)
"Twelve patients had no recurrence at 3 to 15 months after the study."1.30Efficacy of ototopical ciprofloxacin in pediatric patients with otorrhea. ( Hart, MC; Nahata, MC; Wintermeyer, SM, 1997)

Research

Studies (25)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's3 (12.00)18.2507
2000's10 (40.00)29.6817
2010's12 (48.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Gohil, RD1
Syed, MI1
Dombrowski, T1
Gabarain, G1
Baird, R1
Morisada, M1
Anne, S1
Hopkins, B1
Vazquez, A1
Blake, DM1
Jyung, RW1
Faramarzi, M1
Roosta, S1
Shishegar, M1
Abbasi, R1
Atighechi, S1
Mair, EA2
Moss, JR2
Dohar, JE4
Antonelli, PJ1
Bear, M3
LeBel, C3
Park, AH2
Don, D1
Koempel, J1
White, DR1
Yazici, A1
Naiboglu, B1
Oysu, C1
Toros, SZ1
Noseri, H1
Karaca, CT1
Egeli, E1
Dattaray, P1
Pudrith, C1
Nyc, MA1
Martin, D1
Kim, YH1
Jahng, P1
Chung, YS1
Wall, GM3
Jung, T1
Silva, RC1
Hebda, PA2
Lee, DH1
Roland, PS2
Kreisler, LS1
Reese, B1
Anon, JB1
Lanier, B1
Conroy, PJ2
Dupre, SJ2
Potts, S1
Hogg, G1
Stroman, DW1
McLean, C1
Nawasreh, O1
Al-Wedyan, IA1
Lanier, BJ1
Hekkenburg, R1
Lane, EM1
Potts, SL1
Kumar, VV1
Gaughan, J1
Isaacson, G1
Szeremeta, W1
Jang, CH1
Cho, YB1
Choi, CH1
Yuksel, S1
Jha, AK1
Singh, JB1
Dutta, D1
Wintermeyer, SM1
Hart, MC1
Nahata, MC1
Ozagar, A1
Koç, A1
Ciprut, A1
Tutkun, A1
Akdaş, F1
Sehitoğlu, MA1
Fontanel, JP1
Hartnick, CJ1
Shott, S1
Willging, JP1
Myer, CM1
Morpeth, JF1
Bent, JP1
Watson, T1

Clinical Trials (2)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, P3 Study of OTO-201 Given as a Single IT Injection For Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement[NCT01949142]Phase 3266 participants (Actual)Interventional2013-11-30Completed
Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, P3 Study of OTO-201 Given as a Single IT Injection For Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement[NCT01949155]Phase 3266 participants (Actual)Interventional2013-11-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Microbiological Response

Subjects whose samples tested positive for bacteria in either or both ears. (NCT01949142)
Timeframe: Day 15 - 2 weeks after dosing

Interventionpercentage of Microbiological response (Number)
OTO-20181
Sham41

Percentage of Participants Who Were Treatment Failures

"Cumulative proportion of treatment failures:~The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up." (NCT01949142)
Timeframe: Day 15 - 2 weeks after dosing

Interventionpercentage of treatment failures (Number)
OTO-20124.6
Sham44.8

Evaluation of Adverse Events, Otoscopic Exams, Audiometry, and Tympanometry

Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry, vital sign measurements, and physical examinations. (NCT01949142)
Timeframe: Up to one month

,
Interventionpercentage of ears (Number)
Otoscopic abnormal exams @ day 29-left earOtoscopic abnormal exams @ day 29-right earAudiometry Patent tubes @ day 29-left earAudiometry Patent tubes @ day 29-right earTympanometry Category of B (large) day 29-left earTympanometry Category of B (large)day 29-right ear
OTO-2011.10.698.396.089.291.0
Sham2.40.094.196.584.188.9

Microbiological Response

Subjects whose samples tested positive for bacteria in either or both ears at baseline with documented eradication or presumed eradication post-baseline. (NCT01949155)
Timeframe: Day 15 - 2 weeks after dosing

Interventionpercentage of Microbiological response (Number)
OTO-20183
Sham48

Percentage of Participants Who Were Treatment Failures.

"Cumulative proportion of treatment failures:~The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up." (NCT01949155)
Timeframe: Day 15 - 2 weeks after dosing

Interventionpercentage of treatment failures (Number)
OTO-20121.3
Sham45.5

Evaluation of Adverse Events, Otoscopic Exams, Audiometry and Tympanometry

Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry measurements. (NCT01949155)
Timeframe: Up to one month

,
Interventionpercentage of ears (Number)
Otoscopic abnormal exams @ day 29-left earOtoscopic abnormal exams @ day 29-right earAudiometry Patent tubes @ day 29 left earAudiometry Patent tubes @ day 29 right earTympanometry Category of B (large) day 29 left earTympanometry Category of B (large)day 29 right ear
OTO-2011.71.796.096.087.988.2
Sham2.43.510096.587.184.5

Trials

11 trials available for ciprofloxacin and Middle Ear Effusion

ArticleYear
    Laryngo- rhino- otologie, 2017, Volume: 96, Issue:10

    Topics: Anti-Bacterial Agents; Child; Child, Preschool; Ciprofloxacin; Drug Therapy, Combination; Female; Fl

2017
Early Otorrhea Rates: A Randomized Trial of Ciprofloxacin versus Saline Drops after Tympanostomy Tubes.
    The Annals of otology, rhinology, and laryngology, 2019, Volume: 128, Issue:8

    Topics: Administration, Topical; Anti-Bacterial Agents; Child, Preschool; Ciprofloxacin; Female; Humans; Inc

2019
The rationale for preventive treatments for early post-tympanostomy tube otorrhea in persistent otitis media with effusion.
    European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2016, Volume: 273, Issue:6

    Topics: Amoxicillin; Anti-Bacterial Agents; Child; Child, Preschool; Ciprofloxacin; Female; Humans; Incidenc

2016
Randomized Clinical Trial of a Sustained-Exposure Ciprofloxacin for Intratympanic Injection During Tympanostomy Tube Surgery.
    The Annals of otology, rhinology, and laryngology, 2016, Volume: 125, Issue:2

    Topics: Anti-Bacterial Agents; Child; Child, Preschool; Ciprofloxacin; Delayed-Action Preparations; Dose-Res

2016
Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials.
    JAMA otolaryngology-- head & neck surgery, 2016, 05-01, Volume: 142, Issue:5

    Topics: Adolescent; Anti-Bacterial Agents; Audiometry, Pure-Tone; Bone Conduction; Child; Child, Preschool;

2016
Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials.
    JAMA otolaryngology-- head & neck surgery, 2016, 05-01, Volume: 142, Issue:5

    Topics: Adolescent; Anti-Bacterial Agents; Audiometry, Pure-Tone; Bone Conduction; Child; Child, Preschool;

2016
Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials.
    JAMA otolaryngology-- head & neck surgery, 2016, 05-01, Volume: 142, Issue:5

    Topics: Adolescent; Anti-Bacterial Agents; Audiometry, Pure-Tone; Bone Conduction; Child; Child, Preschool;

2016
Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials.
    JAMA otolaryngology-- head & neck surgery, 2016, 05-01, Volume: 142, Issue:5

    Topics: Adolescent; Anti-Bacterial Agents; Audiometry, Pure-Tone; Bone Conduction; Child; Child, Preschool;

2016
Phase 3 Trials of Thermosensitive Ciprofloxacin Gel for Middle Ear Effusion in Children with Tubes.
    Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery, 2016, Volume: 155, Issue:2

    Topics: Adolescent; Anti-Bacterial Agents; Child; Child, Preschool; Ciprofloxacin; Double-Blind Method; Fema

2016
Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes.
    Pediatrics, 2004, Volume: 113, Issue:1 Pt 1

    Topics: Acute Disease; Administration, Topical; Anti-Infective Agents; Anti-Inflammatory Agents; Child; Chil

2004
Prophylactic ciprofloxacin drops after tympanostomy tube insertion.
    Saudi medical journal, 2004, Volume: 25, Issue:1

    Topics: Administration, Topical; Adolescent; Antibiotic Prophylaxis; Child; Child, Preschool; Ciprofloxacin;

2004
Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of granulation tissue in children with acute otitis media with otorrhea through tympanostomy tubes.
    Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery, 2004, Volume: 130, Issue:6

    Topics: Administration, Topical; Adolescent; Anti-Infective Agents; Anti-Inflammatory Agents; Cerebrospinal

2004
Effects of topical otic preparations on hearing in chronic otitis media.
    Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery, 1997, Volume: 117, Issue:4

    Topics: Administration, Topical; Adolescent; Adult; Aged; Anti-Bacterial Agents; Anti-Infective Agents; Audi

1997
A comparison of cortisporin and ciprofloxacin otic drops as prophylaxis against post-tympanostomy otorrhea.
    International journal of pediatric otorhinolaryngology, 2001, Nov-01, Volume: 61, Issue:2

    Topics: Administration, Topical; Chi-Square Distribution; Child; Child, Preschool; Ciprofloxacin; Confidence

2001

Other Studies

14 other studies available for ciprofloxacin and Middle Ear Effusion

ArticleYear
The SIGN 104 guideline (2014) for topical antibiotic prophylaxis during grommet insertion: Misguided?
    Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery, 2018, Volume: 43, Issue:1

    Topics: Administration, Topical; Anti-Bacterial Agents; Antibiotic Prophylaxis; Ciprofloxacin; Clinical Prot

2018
Eosinophilic otitis media.
    Ear, nose, & throat journal, 2014, Volume: 93, Issue:2

    Topics: Adrenal Cortex Hormones; Anti-Inflammatory Agents; Ciprofloxacin; Dexamethasone; Eosinophilia; Femal

2014
Ciprofloxacin (Otiprio) for tympanostomy tube insertion.
    The Medical letter on drugs and therapeutics, 2016, May-23, Volume: 58, Issue:1495

    Topics: Adolescent; Anti-Bacterial Agents; Antibiotic Prophylaxis; Bacterial Infections; Cerebrospinal Fluid

2016
Effect of ototopical ciprofloxacin-dexamethasone on myringotomy in a rat model.
    International journal of pediatric otorhinolaryngology, 2009, Volume: 73, Issue:2

    Topics: Administration, Topical; Animals; Anti-Infective Agents; Anti-Inflammatory Agents; Ciprofloxacin; De

2009
Effect of ciprofloxacin/dexamethasone versus ciprofloxacin/hydrocortisone on lipopolysaccharide-induced experimental otitis media.
    Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery, 2011, Volume: 145, Issue:2

    Topics: Administration, Topical; Animals; Anti-Infective Agents; Anti-Inflammatory Agents; Chinchilla; Cipro

2011
Novel rat model of tympanostomy tube otorrhea.
    International journal of pediatric otorhinolaryngology, 2012, Volume: 76, Issue:2

    Topics: Animals; Anti-Infective Agents; Ciprofloxacin; Cytokines; Dexamethasone; Disease Models, Animal; Eus

2012
Reply to: Novel rat model of tympanostomy tube otorrhea.
    International journal of pediatric otorhinolaryngology, 2012, Volume: 76, Issue:7

    Topics: Animals; Anti-Infective Agents; Ciprofloxacin; Dexamethasone; Disease Models, Animal; Male; Middle E

2012
Oxymetazoline is equivalent to ciprofloxacin in preventing postoperative otorrhea or tympanostomy tube obstruction.
    The Laryngoscope, 2005, Volume: 115, Issue:2

    Topics: Administration, Topical; Adolescent; Adrenergic alpha-Agonists; Anti-Infective Agents; Antibiotic Pr

2005
Structural features of tympanostomy tube biofilm formation in ciprofloxacin-resistant Pseudomonas otorrhea.
    International journal of pediatric otorhinolaryngology, 2007, Volume: 71, Issue:4

    Topics: Anti-Infective Agents; Biofilms; Child; Ciprofloxacin; Drug Resistance, Bacterial; Female; Humans; I

2007
Effects of ciprofloxacin-dexamethasone on myringotomy wound healing.
    The Laryngoscope, 2007, Volume: 117, Issue:3

    Topics: Animals; Anti-Infective Agents; Ciprofloxacin; Dexamethasone; Disease Models, Animal; Drug Combinati

2007
Microorganisms present in discharging otitis media in a group of patients in Kathmandu.
    Nepal Medical College journal : NMCJ, 2007, Volume: 9, Issue:3

    Topics: Acute Disease; Adolescent; Adult; Amikacin; Ciprofloxacin; Female; Gentamicins; Humans; Klebsiella p

2007
Efficacy of ototopical ciprofloxacin in pediatric patients with otorrhea.
    Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery, 1997, Volume: 116, Issue:4

    Topics: Administration, Topical; Adolescent; Anti-Infective Agents; Child; Child, Preschool; Ciprofloxacin;

1997
[Role of ciprofloxacin in the treatment of chronic otitis media].
    Presse medicale (Paris, France : 1983), 1998, Oct-03, Volume: 27, Issue:29

    Topics: Administration, Oral; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; A

1998
Methicillin-resistant Staphylococcus aureus otorrhea after tympanostomy tube placement: an emerging concern.
    Archives of otolaryngology--head & neck surgery, 2000, Volume: 126, Issue:12

    Topics: Administration, Oral; Administration, Topical; Adolescent; Adult; Anti-Bacterial Agents; Anti-Infect

2000