TonsillectomyPhase 1/2NCT03491085
Role of Antibiotics Post Tonsillectomy
A Phase 1/2 study testing Amoxicillin/clavulanate in people with Tonsillectomy, run by Assiut University.
Trial summary
morbidity after tonsillictomy remains asignificant problem therefore they recommend prophylactic antibiotics to reduce it.in the other hand, the overuse of antimicrobial agents can lead to antimicrobial resistance ,adverse drug events,and unnecessary cost.so,the effectiveness and necessity of antibiotic following… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Tonsillectomy
- What is being tested?
- Amoxicillin/clavulanate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2018to 15 Mar 2020
- Phase
- Phase 1/2
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 200 patients who are scheduled for tonsillectomy with or without adenoidectomy, and their age are less than 18 years old of either gender will be included in our study
Who cannot join
- 1-Patients age ≥ 18 years.
- 2-Trials in which antibiotics was administrated locally or used in the immediate preoperative period (within seven days before surgery).
- 3. Medical comorbidity requiring treatment with antibiotics e.g. Rheumatic heart disease
- 4-Patients undergoing the following procedures:
- Unilateral tonsillectomy or biopsy.
- Tonsillectomy for known carcinoma.
- Tonsillectomy in conjunction with palatal surgery.
- Hot tonsillectomy for tonsillar abscess
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study Of The Antibiotic Role In Post Tonsillectomy Complications
morbidity after tonsillictomy remains asignificant problem therefore they recommend prophylactic antibiotics to reduce it.in the other hand, the overuse of antimicrobial agents can lead to antimicrobial resistance ,adverse drug events,and unnecessary cost.so,the effectiveness and necessity of antibiotic following tonsillictomy needs to be studied .
- Conditions
- Tonsillectomy
- Being tested
- Amoxicillin/clavulanate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin/clavulanateDrug
after tonsillectomy half of our patients will receive Amoxicillin /clavulanate for one week and the other half will not receive it.
| Study group | Role | What they receive |
|---|---|---|
| tonsillictomy with antibiotics | Active comparator | Not described Receives: Drug: Amoxicillin/clavulanate |
| tonsillictomy Without Antibiotics | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the morbidity after tonsillectomy between the group which receive antibiotics and the other group which not receive antibiotics
A questionnaire will be given to the parents on discharge to fill in the type of post-tonsillectomy morbidity of main concern including: fever, secondary bleeding, number of days with throat pain and the number of days to resume normal diet, incidence of abdominal pain, nausea \& vomiting.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start15 May 2018 (estimated)
- Primary completion15 Jan 2020 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ahmedz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491085
- Sponsor's protocol ID
- Antibiotics with tonsillectomy
- Status last verified
- May 2018
- First submitted
- 16 Mar 2018
- Last updated
- 17 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel A, Foden N, Rachmanidou A. Is weekend surgery a risk factor for post-tonsillectomy haemorrhage? J Laryngol Otol. 2016 Aug;130(8):763-7. doi: 10.1017/S0022215116008161. Epub 2016 Jun 13.
PubMed 27292442
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Of The Antibiotic Role In Post Tonsillectomy Complications
- ClinicalTrials.gov ID
- NCT03491085
- Acronym / sponsor ID
- Antibiotics with tonsillectomy
- Conditions
- Tonsillectomy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 May 2018 (estimated)
- Primary completion
- 15 Jan 2020 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 9 Apr 2018 (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.
morbidity after tonsillictomy remains asignificant problem therefore they recommend prophylactic antibiotics to reduce it.in the other hand, the overuse of antimicrobial agents can lead to antimicrobial resistance ,adverse drug events,and unnecessary cost.so,the effectiveness and necessity of antibiotic following tonsillictomy needs to be studied .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tonsillictomy with antibiotics | Active comparator | Drug: Amoxicillin/clavulanate |
| tonsillictomy Without Antibiotics | No intervention | – |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 200 patients who are scheduled for tonsillectomy with or without adenoidectomy, and their age are less than 18 years old of either gender will be included in our study
Key exclusion criteria (8 listed)
- 1-Patients age ≥ 18 years.
- 2-Trials in which antibiotics was administrated locally or used in the immediate preoperative period (within seven days before surgery).
- 3. Medical comorbidity requiring treatment with antibiotics e.g. Rheumatic heart disease
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 |
|---|---|---|
| Amoxicillin/clavulanateafter tonsillectomy half of our patients will receive Amoxicillin /clavulanate for one week and the other half will not receive it. | Drug | tonsillictomy with antibiotics |
Primary outcome
compare the morbidity after tonsillectomy between the group which receive antibiotics and the other group which not receive antibiotics
Time frame: 2 years
A questionnaire will be given to the parents on discharge to fill in the type of post-tonsillectomy morbidity of main concern including: fever, secondary bleeding, number of days with throat pain and the number of days to resume normal diet, incidence of abdominal pain, nausea \& vomiting.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Background: PubMed 27292442Patel A, Foden N, Rachmanidou A. Is weekend surgery a risk factor for post-tonsillectomy haemorrhage? J Laryngol Otol. 2016 Aug;130(8):763-7. doi: 10.1017/S0022215116008161. Epub 2016 Jun 13.
- Individual participant dataSharing planned: No
Related trials for Tonsillectomy
Not yet recruiting
Boyle-Davis Mouth Gag Timing in Pediatric Tonsil Surgery
Tonsillectomy and Adenotonsillectomy in Children
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium
Recruiting
Coblator Wand Comparative Analysis
Tonsillectomy, Adenoidectomy
Recruiting
Suprazygomatic Maxillary Nerve Block in Pediatric Tonsillectomy
Tonsillitis
Active, not recruiting
Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis
Tonsillitis Recurrent
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 1/2 study testing Amoxicillin/clavulanate in people with Tonsillectomy, run by Assiut University.
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 8 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 17 May 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 ahmed alhussaini, professor (00201220701447, alhussainiahmad@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the morbidity after tonsillectomy between the group which receive antibiotics and the other group which not receive antibiotics (time frame: 2 years). 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 NCT03491085, which also lists 1 linked publication.
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 17 May 2018.