Mastoiditis; AcutePhase 3COSMICNCT04828525
Corticosteroids as an Additional Treatment for Mastoiditis In Children
A Phase 3 study testing Dexamethasone and normal saline in people with Mastoiditis; Acute, run by ori snapiri.
Trial summary
The aim of the study is to assess the influence of adjuvant corticosteroid treatment in acute mastoiditis in children. we expect a better outcome in children treated with both corticosteroids and antibiotics including lower rates in complications and earlier decline in fever and inflammatory markers. Read more about this study
- Who is it for?
- Ages 6 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Mastoiditis; Acute
- What is being tested?
- Dexamethasone and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 31 Jul 2024
- Phase
- Phase 3
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- acute mastoiditis
Who cannot join
- immunodeficiency (congenital or acquired)
- significant chronic disease
- hypertension
- recurrent mastoiditis
Trial locations and contacts
No sites are listed yet.
About this study
The aim of the study is to assess the influence of adjuvant corticosteroid treatment in acute mastoiditis in children. we expect a better outcome in children treated with both corticosteroids and antibiotics including lower rates in complications and earlier decline in fever and inflammatory markers.
Read the detailed description
The research is a multi-centered, prospective, placebo-control, randomized controlled trial. The study group will be comprised of children diagnosed with acute mastoiditis and hospitalized in a pediatric medical center.
The participating patients will be randomized divided into two groups. Research group will be given dexamethasone treatment (course of 16 doses, 0.15 mg/kg/dose every 6 hours) in addition to antibiotic treatment. Control group will be given 16 doses of 0.9% normal saline in addition to antibiotic treatment. Management and treatment will be conducted according to clinical condition and laboratory findings as for routine institution protocols. It should be noted that the regular institutional management of children enrolled for the study will not be changed due to our research.
- Conditions
- Mastoiditis; Acute
- Being tested
- Dexamethasone, normal saline
- Keywords
- mastoiditis, children, corticosteroids
- Medical subject headings
- Mastoiditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
adjuvant dexamethasone treatment
normal salineDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | participants will be given corticosteroids in addition to conventional treatment Receives: Drug: Dexamethasone |
| Placebo | Placebo comparator | participants will be given normal saline in addition to conventional treatment Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from the beginning of the treatment until clinical and laboratory findings are within normal limits
fever, crp levels
Measured: during hospitalization, anticipated 1-2 weeks
Secondary outcomes (1)
Complication rates
sinus vein thrombosis, intracranial collection or abscess, need for surgery
Measured: during hospitalization, anticipated 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 Apr 2021 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mastoiditis; AcuteStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research is a multi-centered, prospective, placebo-control, randomized controlled trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ori snapiri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ori snapiri, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828525
- Sponsor's protocol ID
- 0702-20-RMC
- Acronym
- COSMIC
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin HW, Shargorodsky J, Gopen Q. Clinical strategies for the management of acute mastoiditis in the pediatric population. Clin Pediatr (Phila). 2010 Feb;49(2):110-5. doi: 10.1177/0009922809344349. Epub 2009 Sep 4.
PubMed 19734439Groth A, Enoksson F, Hultcrantz M, Stalfors J, Stenfeldt K, Hermansson A. Acute mastoiditis in children aged 0-16 years--a national study of 678 cases in Sweden comparing different age groups. Int J Pediatr Otorhinolaryngol. 2012 Oct;76(10):1494-500. doi: 10.1016/j.ijporl.2012.07.002. Epub 2012 Jul 23.
PubMed 22832239Delgado-Noguera MF, Forero Delgadillo JM, Franco AA, Vazquez JC, Calvache JA. Corticosteroids for septic arthritis in children. Cochrane Database Syst Rev. 2018 Nov 21;11(11):CD012125. doi: 10.1002/14651858.CD012125.pub2.
PubMed 30480764Aljebab F, Choonara I, Conroy S. Systematic review of the toxicity of short-course oral corticosteroids in children. Arch Dis Child. 2016 Apr;101(4):365-70. doi: 10.1136/archdischild-2015-309522. Epub 2016 Jan 14.
PubMed 26768830Brouwer MC, McIntyre P, Prasad K, van de Beek D. Corticosteroids for acute bacterial meningitis. Cochrane Database Syst Rev. 2015 Sep 12;2015(9):CD004405. doi: 10.1002/14651858.CD004405.pub5.
PubMed 26362566
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroids as an Additional Treatment for Mastoiditis In Children
- ClinicalTrials.gov ID
- NCT04828525
- Acronym / sponsor ID
- COSMIC / 0702-20-RMC
- Conditions
- Mastoiditis; Acute
- Keywords
- mastoiditis, children, corticosteroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ori snapiriUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 2 Apr 2021 (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.
The aim of the study is to assess the influence of adjuvant corticosteroid treatment in acute mastoiditis in children. we expect a better outcome in children treated with both corticosteroids and antibiotics including lower rates in complications and earlier decline in fever and inflammatory markers.
Detailed description
The research is a multi-centered, prospective, placebo-control, randomized controlled trial. The study group will be comprised of children diagnosed with acute mastoiditis and hospitalized in a pediatric medical center.
The participating patients will be randomized divided into two groups. Research group will be given dexamethasone treatment (course of 16 doses, 0.15 mg/kg/dose every 6 hours) in addition to antibiotic treatment. Control group will be given 16 doses of 0.9% normal saline in addition to antibiotic treatment. Management and treatment will be conducted according to clinical condition and laboratory findings as for routine institution protocols. It should be noted that the regular institutional management of children enrolled for the study will not be changed due to our research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The research is a multi-centered, prospective, placebo-control, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Dexamethasoneparticipants will be given corticosteroids in addition to conventional treatment |
| Placebo | Placebo comparator | Drug: normal salineparticipants will be given normal saline in addition to conventional treatment |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- acute mastoiditis
Key exclusion criteria (4 listed)
- immunodeficiency (congenital or acquired)
- significant chronic disease
- hypertension
- recurrent mastoiditis
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 |
|---|---|---|
| Dexamethasoneadjuvant dexamethasone treatment | Drug | Experimental |
| normal salineplacebo | Drug | Placebo |
Primary outcome
Time from the beginning of the treatment until clinical and laboratory findings are within normal limits
Time frame: during hospitalization, anticipated 1-2 weeks
fever, crp levels
1 secondary outcome
Complication rates
Time frame: during hospitalization, anticipated 1-2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Background: PubMed 19734439Lin HW, Shargorodsky J, Gopen Q. Clinical strategies for the management of acute mastoiditis in the pediatric population. Clin Pediatr (Phila). 2010 Feb;49(2):110-5. doi: 10.1177/0009922809344349. Epub 2009 Sep 4.
- Background: PubMed 22832239Groth A, Enoksson F, Hultcrantz M, Stalfors J, Stenfeldt K, Hermansson A. Acute mastoiditis in children aged 0-16 years--a national study of 678 cases in Sweden comparing different age groups. Int J Pediatr Otorhinolaryngol. 2012 Oct;76(10):1494-500. doi: 10.1016/j.ijporl.2012.07.002. Epub 2012 Jul 23.
- Background: PubMed 30480764Delgado-Noguera MF, Forero Delgadillo JM, Franco AA, Vazquez JC, Calvache JA. Corticosteroids for septic arthritis in children. Cochrane Database Syst Rev. 2018 Nov 21;11(11):CD012125. doi: 10.1002/14651858.CD012125.pub2.
- Background: PubMed 26768830Aljebab F, Choonara I, Conroy S. Systematic review of the toxicity of short-course oral corticosteroids in children. Arch Dis Child. 2016 Apr;101(4):365-70. doi: 10.1136/archdischild-2015-309522. Epub 2016 Jan 14.
- Background: PubMed 26362566Brouwer MC, McIntyre P, Prasad K, van de Beek D. Corticosteroids for acute bacterial meningitis. Cochrane Database Syst Rev. 2015 Sep 12;2015(9):CD004405. doi: 10.1002/14651858.CD004405.pub5.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone and normal saline in people with Mastoiditis; Acute, run by ori snapiri.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ori Snapiri, Dr (+972547242654, orisnapiri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from the beginning of the treatment until clinical and laboratory findings are within normal limits (time frame: during hospitalization, anticipated 1-2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04828525, which also lists 5 linked publications.
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 6 Apr 2021.