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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04321733
Other study ID # Bacteriology of Tonsillitis
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2020
Est. completion date October 2021

Study information

Verified date March 2020
Source Assiut University
Contact Mena W Dous, Principal investigator
Phone +201277170022
Email Dr_manoon@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 ?


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 66
Est. completion date October 2021
Est. primary completion date April 2021
Accepts healthy volunteers No
Gender All
Age group 5 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Amoxicillin Clavulanate
Intravenous drug intake of our drug.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (3)

Brook I. Overcoming penicillin failures in the treatment of Group A streptococcal pharyngo-tonsillitis. Int J Pediatr Otorhinolaryngol. 2007 Oct;71(10):1501-8. Epub 2007 Jul 17. Review. — View Citation

Casey 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. Epub 2007 Feb 9. Review. — View Citation

Sela 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Baseline

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