OtorrheaPhase 4NCT03347461
Otiprio Versus Ciprodex Tympanostomy Tube Outcomes
A Phase 4 study testing Otiprio and Ciprodex in people with Otorrhea and Otitis Media With Effusion in Children, run by Boston Medical Center at 1 site in United States.
Trial summary
Otolaryngologists routinely administer ear drops at the time of tympanostomy tube placement in order to prevent tube otorrhea; however, there is a lack of consensus as to which drops are the most effective, and whether a post-operative regimen should be used. Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Otorrhea, Otitis Media With Effusion in Children
- What is being tested?
- Otiprio and Ciprodex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2018to Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (6 months to 10 years)
- Clinical diagnosis of bilateral middle ear effusion or recurrent acute otitis media requiring tympanostomy tube placement
Who cannot join
- Patient having any other concurrent surgery
- History of mastoid surgery, chronic or recurrent bacterial infections
- Tympanic membrane perforations
- History of immunodeficiency disease
- Abnormalities of the tympanic membrane or middle ear
- Otic or systemic corticosteroid within 7 days of surgery
Show all 10Show fewer
- Topical or systemic antimicrobials or antifungal agents prior to their particular washout intervals
- Concurrent use of anti-inflammatory agents
- Allergy to the medications used in this study and their components
- Menarcheal or postmenarcheal female.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Otiprio Versus Ciprodex to Reduce Tympanostomy Tube Failure
Otolaryngologists routinely administer ear drops at the time of tympanostomy tube placement in order to prevent tube otorrhea; however, there is a lack of consensus as to which drops are the most effective, and whether a post-operative regimen should be used. Utilizing drops postoperatively places the onus of administration on parents who may have various difficulties in delivering the drops to their child's ears. Additionally, prescribing drops postoperatively is a health care cost. The purpose of this study is to determine if there is a difference in prevention of tympanostomy tube failure (defined as tube blockage or otorrhea) between Otiprio administered once intraoperatively, Ciprodex otic dropgs administered once intraoperatively, and Ciprodex otic drops administered intraoperatively with a postoperative course.
Read the detailed description
Tympanostomy tube placement is indicated in children with recurrent acute otitis media or chronic otitis media with effusion. Ear dishcarge, otorrhea, is the most common complication following tympanostomy tube placement and occurs in up to 25% of patients. Otorrhea can lead to tube obstruction, making the tube ineffective in ventilating the middle ear or improving hearing. Otolaryngologists routinely administer ear drops at the time of tympanostomy tube placement in order to prevent otorrhea and tube blockage; however, there is lack of consensus as to which drops are the most effective and what dosing regimen should be used.
Options for prevention of otorrhea and tympanostomy tube blockage include intraoperative single-dose application of topical drops or postoperative prolonged application of topical drops. One issue with the prolonged application of drops after surgery is the requirement of parents to administer the drops at home. Thus, the delivery of medication to the middle ear is variable given the difficulty of administering ear drops to a child. Another option exists as a one-time application at the time of surgery, but provides an extended duration of medication in the middle ear. Otiprio is a single-dose suspension of ciprofloxacin and has been FDA approved since February 2015 for use in pediatric patients with otitis media with effusion who require tympanostomy tube placement. Otiprio exists as a liquid at or below room temperature and transitions into a gel after exposure to body temperature in the middle ear. Administrated as an injection into the middle ear at the time of tympanostomy tube placement, Otipiro slowly releases antibiotic treatment over the course of a week, eliminating the need for parents to administer drops.
The study is a prospective, randomized (1:1:1), single-blind, trial of three treatment groups in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement. Approximately 300 subjects will be randomized: 100 randomized to receive Otiprio intraoperatively, 100 randomized to receive Ciprodex intraoperatively, and 100 randomized to receive Ciprodex intraoperatively with five days of Ciprodex drops postoperatively.
All participants will undergo tympanostomy tube placement in the operating room as clinically indicated by an Otolaryngologist. Prior to the surgery, the patient will be randomized to one of the three trial arms. During the operation, the surgeon, who will be blinded until completion of tube placement as to which arm the participant is randomized, will administer Otiprio as a one-time intratympanic injection or Ciprodex, by administering 3-5 drops into each ear canal. For the trial arm that includes a 5 day course of Ciprodex postoperatively, the patient's parents will be instructed on how to administer the drops. As per standard of care, all participants will be assessed at a postoperative visit 2-4 weeks post surgery. A blinded assessor to the randomized study arm will perform otoscopy (ear exam) during that visit to determine if there is presence of otorrhea or tympanostomy tube blockage.
- Conditions
- Otorrhea, Otitis Media With Effusion in Children
- Being tested
- Otiprio, Ciprodex
- Keywords
- Tympanostomy tube placement, Otiprio, Ciprodex drops, Ear drops, Middle ear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtiprioDrug
Also called ciprofloxacin otic suspension
Otiprio is a single-dose, physician-administered, sustained-exposure otic fluoroquinolone antibacterial for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement surgery. Otoprio (6% ciprofloxacin, 60 mg/mL) will be administered through the tube lumen by the otolaryngologist immediately after tympanostomy surgery.
CiprodexDrug
Also called ciprofloxacin and dexamethasone
Ciprodex is a combined antibiotic and steroid ear drop used to treat otitis media with tympanostomy tubes. Four drops of Ciprodex (0.14mL) instilled by the otolaryngologist into the affected ear immediately after tympanostomy surgery. Each mL of Ciprodex contains ciprofloxacin hydrochloride 0.3 % (equivalent to 3 mg ciprofloxacin base) and dexamethasone 0.1 % equivalent to 1 mg dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Otiprio by surgeon | Experimental | Otiprio will be administered through the tympanic membrane by the otolaryngologist immediately after tympanostomy placement. Receives: Drug: Otiprio |
| Ciprodex by surgeon | Active comparator | Ciprodex drops will be instilled by the otolaryngologist into the affected ear immediately after tympanostomy surgery. Receives: Drug: Ciprodex |
| Ciprodex by surgeon and parent | Active comparator | Ciprodex drops will be instilled by the otolaryngologist into the ear immediately after tympanostomy tube surgery. The parent or guardian will administer Ciprodex drops into the ears twice daily for five days after surgery. Receives: Drug: Ciprodex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative otorrhea
Otorrhea is drainage from the ear. Evaluation will be performed by a blind assessor via otoscopy.
Measured: Post operative visit 2-4 weeks after tube placement
Tympanostomy tube blockage
Tympanostomy tube blockage is when the placed tube becomes clogged or obstructed. Evaluation will be performed by a blind assessor via otoscopy.
Measured: Post operative visit 2-4 weeks after tube placement
Secondary outcomes (1)
Resolution of effusion post operatively
Effusion is the presence of middle ear fluid. Evaluation will be performed by a blind assessor via otoscopy.
Measured: Post operative visit 2-4 weeks after tube placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study startOct 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Why it stopped: Low use of Otiprio among otolaryngologists.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtorrheaStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Weber, MD, Study chair, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347461
- Sponsor's protocol ID
- H-37078
- Status last verified
- Sep 2018
- First submitted
- 16 Nov 2017
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Otiprio Versus Ciprodex to Reduce Tympanostomy Tube Failure
- ClinicalTrials.gov ID
- NCT03347461
- Acronym / sponsor ID
- H-37078
- Conditions
- Otorrhea, Otitis Media With Effusion in Children
- Keywords
- Tympanostomy tube placement, Otiprio, Ciprodex drops, Ear drops, Middle ear
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low use of Otiprio among otolaryngologists.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Otolaryngologists routinely administer ear drops at the time of tympanostomy tube placement in order to prevent tube otorrhea; however, there is a lack of consensus as to which drops are the most effective, and whether a post-operative regimen should be used. Utilizing drops postoperatively places the onus of administration on parents who may have various difficulties in delivering the drops to their child's ears. Additionally, prescribing drops postoperatively is a health care cost. The purpose of this study is to determine if there is a difference in prevention of tympanostomy tube failure (defined as tube blockage or otorrhea) between Otiprio administered once intraoperatively, Ciprodex otic dropgs administered once intraoperatively, and Ciprodex otic drops administered intraoperatively with a postoperative course.
Detailed description
Tympanostomy tube placement is indicated in children with recurrent acute otitis media or chronic otitis media with effusion. Ear dishcarge, otorrhea, is the most common complication following tympanostomy tube placement and occurs in up to 25% of patients. Otorrhea can lead to tube obstruction, making the tube ineffective in ventilating the middle ear or improving hearing. Otolaryngologists routinely administer ear drops at the time of tympanostomy tube placement in order to prevent otorrhea and tube blockage; however, there is lack of consensus as to which drops are the most effective and what dosing regimen should be used.
Options for prevention of otorrhea and tympanostomy tube blockage include intraoperative single-dose application of topical drops or postoperative prolonged application of topical drops. One issue with the prolonged application of drops after surgery is the requirement of parents to administer the drops at home. Thus, the delivery of medication to the middle ear is variable given the difficulty of administering ear drops to a child. Another option exists as a one-time application at the time of surgery, but provides an extended duration of medication in the middle ear. Otiprio is a single-dose suspension of ciprofloxacin and has been FDA approved since February 2015 for use in pediatric patients with otitis media with effusion who require tympanostomy tube placement. Otiprio exists as a liquid at or below room temperature and transitions into a gel after exposure to body temperature in the middle ear. Administrated as an injection into the middle ear at the time of tympanostomy tube placement, Otipiro slowly releases antibiotic treatment over the course of a week, eliminating the need for parents to administer drops.
The study is a prospective, randomized (1:1:1), single-blind, trial of three treatment groups in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement. Approximately 300 subjects will be randomized: 100 randomized to receive Otiprio intraoperatively, 100 randomized to receive Ciprodex intraoperatively, and 100 randomized to receive Ciprodex intraoperatively with five days of Ciprodex drops postoperatively.
All participants will undergo tympanostomy tube placement in the operating room as clinically indicated by an Otolaryngologist. Prior to the surgery, the patient will be randomized to one of the three trial arms. During the operation, the surgeon, who will be blinded until completion of tube placement as to which arm the participant is randomized, will administer Otiprio as a one-time intratympanic injection or Ciprodex, by administering 3-5 drops into each ear canal. For the trial arm that includes a 5 day course of Ciprodex postoperatively, the patient's parents will be instructed on how to administer the drops. As per standard of care, all participants will be assessed at a postoperative visit 2-4 weeks post surgery. A blinded assessor to the randomized study arm will perform otoscopy (ear exam) during that visit to determine if there is presence of otorrhea or tympanostomy tube blockage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Otiprio by surgeon | Experimental | Drug: OtiprioOtiprio will be administered through the tympanic membrane by the otolaryngologist immediately after tympanostomy placement. |
| Ciprodex by surgeon | Active comparator | Drug: CiprodexCiprodex drops will be instilled by the otolaryngologist into the affected ear immediately after tympanostomy surgery. |
| Ciprodex by surgeon and parent | Active comparator | Drug: CiprodexCiprodex drops will be instilled by the otolaryngologist into the ear immediately after tympanostomy tube surgery. The parent or guardian will administer Ciprodex drops into the ears twice daily for five days after surgery. |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children (6 months to 10 years)
- Clinical diagnosis of bilateral middle ear effusion or recurrent acute otitis media requiring tympanostomy tube placement
Key exclusion criteria (10 listed)
- Patient having any other concurrent surgery
- History of mastoid surgery, chronic or recurrent bacterial infections
- Tympanic membrane perforations
- History of immunodeficiency disease
- Abnormalities of the tympanic membrane or middle ear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OtiprioAlso: ciprofloxacin otic suspensionOtiprio is a single-dose, physician-administered, sustained-exposure otic fluoroquinolone antibacterial for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement surgery. Otoprio (6% ciprofloxacin, 60 mg/mL) will be administered through the tube lumen by the otolaryngologist immediately after tympanostomy surgery. | Drug | Otiprio by surgeon |
| CiprodexAlso: ciprofloxacin and dexamethasoneCiprodex is a combined antibiotic and steroid ear drop used to treat otitis media with tympanostomy tubes. Four drops of Ciprodex (0.14mL) instilled by the otolaryngologist into the affected ear immediately after tympanostomy surgery. Each mL of Ciprodex contains ciprofloxacin hydrochloride 0.3 % (equivalent to 3 mg ciprofloxacin base) and dexamethasone 0.1 % equivalent to 1 mg dexamethasone | Drug | Ciprodex by surgeon, Ciprodex by surgeon and parent |
Primary outcome
Post operative otorrhea
Time frame: Post operative visit 2-4 weeks after tube placement
Otorrhea is drainage from the ear. Evaluation will be performed by a blind assessor via otoscopy.
Tympanostomy tube blockage
Time frame: Post operative visit 2-4 weeks after tube placement
Tympanostomy tube blockage is when the placed tube becomes clogged or obstructed. Evaluation will be performed by a blind assessor via otoscopy.
1 secondary outcome
Resolution of effusion post operatively
Time frame: Post operative visit 2-4 weeks after tube placement
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Weber, MD study chair
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Otiprio and Ciprodex in people with Otorrhea and Otitis Media With Effusion in Children, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative otorrhea (time frame: Post operative visit 2-4 weeks after tube placement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018.