Acute Follicular TonsillitisNCT04321733
Bacteriological Study of Acute Follicular Tonsillitis
An observational study of Acute Follicular Tonsillitis, run by Assiut University.
Trial summary
The objective of the study is to answer the following questions :- 1. Is there an actual failure rate in tonsillitis treatment with amoxicillin clavulanate ? If yes, 2. What is (are) the possible reason(s) to explain it in our locality ? Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Acute Follicular Tonsillitis
- What is being tested?
- Amoxicillin Clavulanate
- Type of treatment
- Injection or infusion
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Oct 2021
- Phase
- Observational
- 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 5 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with acute follicular tonsillitis
Who may be able to join
- patients with acute follicular tonsillitis neither younger than five years nor older than 60 years old.
Who cannot join
- Other causes of tonsillitis that do not cause suppuration .
- Age below five , and above 60 years .
- Patients who received antibiotic one week before presentation .
- Immune compromised patients .
- Patients with quinsy.
Trial locations and contacts
No sites are listed yet.
Alaa K Abd El Haleem, Professor of Otolaryngology contact
About this study
Official title: Bacteriological Study of Acute Follicular Tonsillitis in Patients Attending the ENT Outpatient Clinic of Assiut University Hospital
The objective of the study is to answer the following questions :-
- Is there an actual failure rate in tonsillitis treatment with amoxicillin clavulanate ? If yes,
- What is (are) the possible reason(s) to explain it in our locality ?
Read the detailed description
Tonsillitis is one of the most common diseases in the throat that occurs in the younger age group .
The predominant bacteria causing tonsillitis are group A b-haemolytic streptococci (GABHS), which are highly susceptible to the penicillin group of antibiotics.
It has been reported in the literature that the rate of penicillin failure has consistently increased from about 7% in the 1950s to almost 40% in the 2000s.
Authors propose many reasons to explain such failure rates e.g. the coexistence of oropharyngeal beta-lactamase producing bacteria .
Although there were no documented reports, it was observed that there are rising reports of failure in treatment of acute follicular tonsillitis by amoxicillin clavulanate.
- Conditions
- Acute Follicular Tonsillitis
- 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
Intravenous drug intake of our drug.
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of the isolated organism to amoxicillin clavulanate according to culture and sensitivity test
throat swabs that will be taken from the tonsillar exudate, placed in sterile bottles and brought to the laboratory for Bacteriological culture of the organism and Antibiotic sensitivity tests will be done for the isolated organism(s).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study startApr 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Follicular TonsillitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mena Wahby Dous Hana, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321733
- Sponsor's protocol ID
- Bacteriology of Tonsillitis
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2020
- Last updated
- 25 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brook I. Overcoming penicillin failures in the treatment of Group A streptococcal pharyngo-tonsillitis. Int J Pediatr Otorhinolaryngol. 2007 Oct;71(10):1501-8. doi: 10.1016/j.ijporl.2007.06.006. Epub 2007 Jul 17.
PubMed 17644191Casey JR, Pichichero ME. The evidence base for cephalosporin superiority over penicillin in streptococcal pharyngitis. Diagn Microbiol Infect Dis. 2007 Mar;57(3 Suppl):39S-45S. doi: 10.1016/j.diagmicrobio.2006.12.020. Epub 2007 Feb 9.
PubMed 17292576Sela S, Barzilai A. Why do we fail with penicillin in the treatment of group A streptococcus infections? Ann Med. 1999 Oct;31(5):303-7. doi: 10.3109/07853899908995895.
PubMed 10574501
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacteriological Study of Acute Follicular Tonsillitis in Patients Attending the ENT Outpatient Clinic of Assiut University Hospital
- ClinicalTrials.gov ID
- NCT04321733
- Acronym / sponsor ID
- Bacteriology of Tonsillitis
- Conditions
- Acute Follicular Tonsillitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 25 Mar 2020 (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 objective of the study is to answer the following questions :-
- Is there an actual failure rate in tonsillitis treatment with amoxicillin clavulanate ? If yes,
- What is (are) the possible reason(s) to explain it in our locality ?
Detailed description
Tonsillitis is one of the most common diseases in the throat that occurs in the younger age group .
The predominant bacteria causing tonsillitis are group A b-haemolytic streptococci (GABHS), which are highly susceptible to the penicillin group of antibiotics.
It has been reported in the literature that the rate of penicillin failure has consistently increased from about 7% in the 1950s to almost 40% in the 2000s.
Authors propose many reasons to explain such failure rates e.g. the coexistence of oropharyngeal beta-lactamase producing bacteria .
Although there were no documented reports, it was observed that there are rising reports of failure in treatment of acute follicular tonsillitis by amoxicillin clavulanate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with acute follicular tonsillitis
Key inclusion criteria (1 listed)
- patients with acute follicular tonsillitis neither younger than five years nor older than 60 years old.
Key exclusion criteria (5 listed)
- Other causes of tonsillitis that do not cause suppuration .
- Age below five , and above 60 years .
- Patients who received antibiotic one week before presentation .
- Immune compromised patients .
- Patients with quinsy.
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 ClavulanateIntravenous drug intake of our drug. | Drug | – |
Primary outcome
The sensitivity of the isolated organism to amoxicillin clavulanate according to culture and sensitivity test
Time frame: Baseline
throat swabs that will be taken from the tonsillar exudate, placed in sterile bottles and brought to the laboratory for Bacteriological culture of the organism and Antibiotic sensitivity tests will be done for the isolated organism(s).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Background: PubMed 17644191Brook I. Overcoming penicillin failures in the treatment of Group A streptococcal pharyngo-tonsillitis. Int J Pediatr Otorhinolaryngol. 2007 Oct;71(10):1501-8. doi: 10.1016/j.ijporl.2007.06.006. Epub 2007 Jul 17.
- Background: PubMed 17292576Casey JR, Pichichero ME. The evidence base for cephalosporin superiority over penicillin in streptococcal pharyngitis. Diagn Microbiol Infect Dis. 2007 Mar;57(3 Suppl):39S-45S. doi: 10.1016/j.diagmicrobio.2006.12.020. Epub 2007 Feb 9.
- Background: PubMed 10574501Sela S, Barzilai A. Why do we fail with penicillin in the treatment of group A streptococcus infections? Ann Med. 1999 Oct;31(5):303-7. doi: 10.3109/07853899908995895.
- Individual participant dataSharing planned: Undecided
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.
Alaa K Abd El Haleem, Professor of Otolaryngology contact
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Follicular Tonsillitis, 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 5 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 25 Mar 2020. 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.
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 Mena W Dous, Principal investigator (+201277170022, Dr_manoon@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity of the isolated organism to amoxicillin clavulanate according to culture and sensitivity test (time frame: Baseline). 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 NCT04321733, which also lists 3 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 25 Mar 2020.