Skip to main content
OpenTrials
Completed

NCT Number: NCT04215770

Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tonsillitis Streptococcal Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases Tonsillitis

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CMH Mradan

Mardan, KPK, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Other names: Group A and B

Primary outcomes

  1. treatment efficacy

    Time frame: 10 days

    full recovery (Centor score became zero/nil)

Sponsors and collaborators

Lead sponsor

Combined Military Hospital, Pakistan

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2020
Registry last updated
Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.