NCT04321733

Brief Summary

The objective of the study is to answer the following questions :-

  1. 1.Is there an actual failure rate in tonsillitis treatment with amoxicillin clavulanate ? If yes,
  2. 2.What is (are) the possible reason(s) to explain it in our locality ?

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 19, 2020

Last Update Submit

March 24, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Intravenous drug intake of our drug.

Eligibility Criteria

Age5 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute follicular tonsillitis

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1016/j.ijporl.2007.06.006. Epub 2007 Jul 17.

    PMID: 17644191BACKGROUND
  • 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. doi: 10.1016/j.diagmicrobio.2006.12.020. Epub 2007 Feb 9.

    PMID: 17292576BACKGROUND
  • 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. doi: 10.3109/07853899908995895.

    PMID: 10574501BACKGROUND

Related Links

MeSH Terms

Interventions

Amoxicillin-Potassium Clavulanate Combination

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Central Study Contacts

Mena W Dous, Principal investigator

CONTACT

Alaa K Abd El Haleem, Professor of Otolaryngology

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 25, 2020

Study Start

April 1, 2020

Primary Completion

April 1, 2021

Study Completion

October 1, 2021

Last Updated

March 25, 2020

Record last verified: 2020-03