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Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin

Primary Purpose

Tonsillitis Streptococcal

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Tonsillitis Streptococcal focused on measuring Co-amoxiclav, Benzyl Penicilli, Tonsillitis

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

CMH Mradan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Inj Co-amoxiclav

Inj Benzyl Penicillin

Arm Description

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

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

Outcomes

Primary Outcome Measures

treatment efficacy

full recovery (Centor score became zero/nil)

Secondary Outcome Measures

Full Information

NCT ID

NCT04215770

First Posted

December 29, 2019

Last Updated

January 2, 2020

Sponsor

Combined Military Hospital, Pakistan

1. Study Identification

Unique Protocol Identification Number

NCT04215770

Brief Title

Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin

Official Title

Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin in Children With Severe Tonsillitis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

November 1, 2019 (Actual)

Study Completion Date

November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Combined Military Hospital, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

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

Detailed Description

Efficacy was measured through improvement (decrease in fever, settling lymphadenopathy and disappearance of tonsillar exudate) in Centor Criteria score on daily basis. Improvement i.e reduction in Centor Criteria score was recorded for all children till full recovery. Safety was measured by frequency of hypersensitivity reactions or severe side effects of antibiotics necessitating stoppage of the drug. All the children in both Groups were given test dose of the antibiotic before giving full dose of antibiotic prescribed. Cost effectiveness was compared in terms of total cost of injections (Co-amoxiclav versus Benzyl penicillin) which were administered to children in both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tonsillitis Streptococcal

Keywords

Co-amoxiclav, Benzyl Penicilli, Tonsillitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

single blinded clinical trial

Masking

Participant

Allocation

Randomized

Enrollment

310 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inj Co-amoxiclav

Arm Type

Active Comparator

Arm Description

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

Arm Title

Inj Benzyl Penicillin

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Group A and B

Intervention Description

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

Primary Outcome Measure Information:

Title

treatment efficacy

Description

full recovery (Centor score became zero/nil)

Time Frame

10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Khan, MBBS, FCPS

Organizational Affiliation

CMH Mardan

Official's Role

Principal Investigator

Facility Information:

Facility Name

CMH Mradan

City

Mardan

State/Province

KPK

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

It will not be shared

Learn more about this trial

Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin

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