Bacteriological Study of Acute Follicular Tonsillitis

March 24, 2020 updated by: Mena Wahby Dous Hana, Assiut University

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 :-

  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 ?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Alaa K Abd El Haleem, Professor of Otolaryngology
  • Phone Number: +201005534200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 58 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with acute follicular tonsillitis

Description

Inclusion criteria:

patients with acute follicular tonsillitis neither younger than five years nor older than 60 years old.

Exclusion Criteria:

  1. Other causes of tonsillitis that do not cause suppuration .
  2. Age below five , and above 60 years .
  3. Patients who received antibiotic one week before presentation .
  4. Immune compromised patients .
  5. Patients with quinsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (Actual)

March 25, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bacteriology of Tonsillitis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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