Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04215770

Enrollment

310

Registered

2020-01-02

Start date

2018-01-01

Completion date

2019-11-01

Last updated

2020-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tonsillitis Streptococcal

Keywords

Co-amoxiclav, Benzyl Penicilli, Tonsillitis

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.

Interventions

DRUGinj 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Intervention model description

single blinded clinical trial

Eligibility

Sex/Gender

ALL

Age

5 Years to 15 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
treatment efficacy	10 days	full recovery (Centor score became zero/nil)

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026