Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin

Study Overview
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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.

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

Conditions
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Tonsillitis Streptococcal

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single blinded clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inj Co-amoxiclav<br>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<br>* Patients of both groups were examined and compared in terms of efficacy of treatment, safety and cost effectiveness<br>* Other names: Group A and B;|
| Active Comparator: Inj Benzyl Penicillin<br>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<br>* Patients of both groups were examined and compared in terms of efficacy of treatment, safety and cost effectiveness<br>* Other names: Group A and B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment efficacy | full recovery (Centor score became zero/nil) | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Co-amoxiclav, Benzyl Penicilli, Tonsillitis