Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin

Not Applicable

Completed

• Conditions: Tonsillitis Streptococcal
• Interventions: Drug: inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day

• Registration Number: NCT04215770
• Lead Sponsor: Combined Military Hospital, Pakistan

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-29
• Study First Submitted QC: 2019-12-29
• Study First Posted: 2020-01-02
• Last Update Submitted: 2020-01-02
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inj Co-amoxiclav	inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day	Group A children were advised Inj Co-amoxiclav 50 units/kg/day in 3 divided doses daily
Inj Benzyl Penicillin	inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day	Group B patients were advised inj Benzyl Penicillin 25000 units/kg/day in 3 divided doses

Primary Outcome Measures

Name	Time	Method
treatment efficacy	10 days	full recovery (Centor score became zero/nil)

Trial Locations

Locations (1)

CMH Mradan; 🇵🇰 Mardan, KPK, Pakistan