NCT04215770

Brief Summary

To compare intravenous Co-amoxiclav versus Benzyl penicillin in children with severe streptococcal tonsillitis in terms of efficacy, safety and cost effectiveness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
Last Updated

January 3, 2020

Status Verified

December 1, 2019

Enrollment Period

1.8 years

First QC Date

December 29, 2019

Last Update Submit

January 2, 2020

Conditions

Tonsillitis Streptococcal

Keywords

Co-amoxiclavBenzyl PenicilliTonsillitis

Outcome Measures

Primary Outcomes (1)

  • treatment efficacy

    full recovery (Centor score became zero/nil)

    10 days

Study Arms (2)

Inj Co-amoxiclav

ACTIVE COMPARATOR

Group A children were advised Inj Co-amoxiclav 50 units/kg/day in 3 divided doses daily

Drug: inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day

Inj Benzyl Penicillin

ACTIVE COMPARATOR

Group B patients were advised inj Benzyl Penicillin 25000 units/kg/day in 3 divided doses

Drug: inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day

Interventions

inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/dayDRUG

Patients of both groups were examined and compared in terms of efficacy of treatment, safety and cost effectiveness

Also known as: Group A and B
Inj Benzyl PenicillinInj Co-amoxiclav

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children who had 3 or 4 score according to Centor Criteria for tonsillitis/pharyngotonsillitis, were included in study
  • Children between ages of 5 to 15 years
  • Children with positive Rapid Antigen detection Test (RADT) for Streptococcus Pyogenes

You may not qualify if:

  • Immunocompromised children
  • Children with known hypersensitivity to Penicillins (esp Coamoxiclav and Benzyl penicillin)
  • Children with liver or renal failure
  • Children who were already using any oral or parenteral antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMH Mradan

Mardan, KPK, Pakistan

Location

MeSH Terms

Conditions

Tonsillitis

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Ahmed Khan, MBBS, FCPS

    CMH Mardan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: single blinded clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ENT consultant

Study Record Dates

First Submitted

December 29, 2019

First Posted

January 2, 2020

Study Start

January 1, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

January 3, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

It will not be shared

Locations

PA(1)