Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin

NCT ID: NCT04215770

Last Updated: 2020-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-11-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Tonsillitis Streptococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

single blinded clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Inj Co-amoxiclav

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Inj Benzyl Penicillin

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

Other Intervention Names

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Group A and B

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Immunocompromised children
2. Children with known hypersensitivity to Penicillins (esp Coamoxiclav and Benzyl penicillin)
3. Children with liver or renal failure
4. Children who were already using any oral or parenteral antibiotics
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Combined Military Hospital, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Khan

ENT consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Khan, MBBS, FCPS

Role: PRINCIPAL_INVESTIGATOR

CMH Mardan

Locations

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CMH Mradan

Mardan, KPK, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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CMH-01-2019

Identifier Type: -

Identifier Source: org_study_id

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