Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin

Tonsillitis Streptococcal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04215770
• Other study ID #: CMH-01-2019
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: December 2019
• Source: Combined Military Hospital, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Tonsillitis
• Tonsillitis Streptococcal

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Pakistan	CMH Mradan	Mardan	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Combined Military Hospital, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

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